Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products

Size: px
Start display at page:

Download "Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products"

Transcription

1 Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Version 1.3 Drug Office, Department of Health.

2 Contents list 1. QUALITY MANAGEMENT PERSONNEL PREMISES MATERIALS CONTROL GOOD PRACTICES IN SECONDARY PACKAGING QUALITY CONTROL DOCUMENTATION STOCK HANDLING AND STOCK CONTROL REJECTED AND RETURNED GOODS PRODUCT COMPLAINTS PRODUCT RECALL SELF INSPECTION CONTRACT PACKAGING OR ANALYSIS ARRANGEMENTS Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 2

3 PURPOSE OF THIS GUIDANCE This document serves to provide guidance to companies conducting secondary packaging but it is not meant to replace the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The PIC/S Guide to Good Manufacturing Practice for Medicinal Products would be the standard used during the GMP inspection of all manufacturers (including secondary packaging manufacturers) of pharmaceutical products. DEFINITION Secondary packaging is a manufacturing step and means the labelling, relabelling, cartoning, re cartoning or adding additional information (including inserts) to pharmaceutical products which are already enclosed in the container in which they are to be sold or supplied. SCOPE This document applies to any company carrying out the secondary packaging of pharmaceutical products in Hong Kong. Secondary packaging operations involving the application of a supplementary label that does not obliterate, change or display information relating to the original name, list of ingredients, dosage instructions, batch number or expiry date of the pharmaceutical product are exempted from the requirements of this Good Manufacturing Practice (GMP) Guide. Full compliance with the Hong Kong GMP Guidelines for Pharmaceutical Products applies to packaging of a bulk product to become a finished product which involves the use of primary packaging materials. Primary packaging materials are packaging materials that are intended to be in direct contact with the products. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 3

4 1. QUALITY MANAGEMENT 1.1 Companies carrying out secondary packaging of pharmaceutical products should establish and maintain a Quality System setting out responsibilities, organisational structure, resources, processes, procedures and other activities necessary to ensure confidence in the quality of the products released for supply after secondary packaging. 1.2 The Quality System should be fully documented and its effectiveness monitored on a regular basis. All Quality System related activities should be defined and documented. A Quality Manual or equivalent documentation approach should be established and maintained. 1.3 Management should appoint a Quality Assurance Officer who should have defined responsibilities for ensuring that a Quality System is implemented and maintained. 1.4 A system should be established and maintained to approve suppliers of packaging materials to be used in secondary packaging. In the case of critical materials such as printed packaging materials, the reliability of the suppliers may need to be verified by the Quality Assurance Officer conducting on site audits. 1.5 The Quality System should ensure that: a. Management responsibilities are clearly defined. b. A system of change control is in place to document and manage any changes that may impact the quality of the final product. c. Appropriate corrective and preventative actions (commonly known as CAPA) are taken (and documented) to correct deviations and prevent their re occurrence. 2. PERSONNEL Key Personnel 2.1 Key personnel include Person in charge of secondary packaging and Quality Assurance Officer. They must be independent from each other. There should be a staff organisation chart showing this independence. 2.2 The company should appoint a Person in charge of secondary packaging to be responsible for the following activities: a. Establish and maintain the company s Quality System, and coordinate regular reviews of the effectiveness of the Quality System. b. Supervise the secondary packaging operations. c. Ensure that products are packaged and stored according to the appropriate documentation in order to obtain the required quality. d. Approval of documentation and procedures relating to secondary packaging operations. e. Check the maintenance of premises and equipment. f. Coordination of self inspections. g. Ensure that the required training of his department personnel is carried out and adapted according to need. 2.3 The company should also appoint a Quality Assurance Officer to be responsible for the following activities: a. Establish and maintain the company s Quality System, and coordinate regular reviews of the effectiveness of the Quality System. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 4

5 b. Approval of products received for secondary packaging. c. Approval of packaging materials, including printed packaging materials, before they are used in secondary packaging operations. d. Approval of documentation and procedures relating to quality control. e. Certification that each batch of pharmaceutical product that is subject to secondary packaging has been processed and controlled in accordance with the requirements set out in this guidance document before the batch is released for sale or supply. f. Establish and maintain a list of approved suppliers of packaging materials, including printed packaging materials, to be used in secondary packaging operations. g. Coordination of self inspections. h. Coordination of the handling of complaints and recalls. i. Approval of contract agreements. j. Ensure that the required training of his department personnel is carried out and adapted according to need. Qualifications of Key Personnel 2.4 The Person in charge of secondary packaging operations should have adequate academic qualification, sufficient experience in pharmaceutical manufacture and/or secondary packaging, and necessary knowledge in the principle of GMP, to enable an understanding of the risks associated with the activities being undertaken and the regulatory environment. 2.5 The Quality Assurance Officer should have adequate academic qualification and the necessary knowledge in the principles of GMP and legislation related to pharmaceutical products. This person should have sufficient experience in secondary packaging of pharmaceutical products and should have a clear understanding of the risks associated with the activities being undertaken in the regulatory environment. Training 2.6 Adequate training should be provided for all personnel whose activities could affect the quality of the final products. Training programs should be available and its practical effectiveness should be periodically assessed. Records of training provided to personnel should be maintained. Personal Hygiene 2.7 Every person entering the secondary packaging area(s) should wear protective garments appropriate to the operations to be carried out which includes at least a hair cover and clean protective garments. 2.8 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the packaging and storage areas should be prohibited. In general, any unhygienic practice within the packaging areas or in any other area where the product might be adversely affected should be forbidden. 2.9 Visitors or untrained personnel should, preferably, not be taken into the secondary packaging area(s). If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 5

6 3. PREMISES 3.1 Premises used for secondary packaging should be specifically designed, constructed and laid out to avoid product mix up and cross contamination. 3.2 The size of the secondary packaging area(s) should reflect the volume of work involved. The adequacy of the working space or work bench for secondary packaging should permit the orderly and logical positioning of equipment and materials so as to avoid confusion and to minimize the risk of mix up between different pharmaceutical products and their components. 3.3 Secondary packaging areas and associated storage areas should be well lit and effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled and to the operations undertaken within them. Temperature and humidity should be monitored regularly, and record made in a logbook. 3.4 There should be adequate storage areas with general good housekeeping. The storage areas should be designed and equipped to prevent the entry of insects, rodents and other animals. 3.5 There should be a pest control program to control the entry of insects, rodents and other animals. Appropriate records should be kept. 3.6 Segregated areas should be provided for the storage of approved, quarantined, rejected, recalled and returned materials or products. 3.7 Rest and refreshment rooms should be separate from the secondary packaging area(s). 3.8 Adequate toilet facilities should be available and should be kept clean and in good order. Toilets should not open directly into the secondary packaging area(s). 3.9 Premises should be cleaned and, where applicable, disinfected according to detailed written procedures. Appropriate records should be kept. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 6

7 4. MATERIALS CONTROL Products subject to Secondary Packaging 4.1 For each delivery of pharmaceutical product received for secondary packaging, the containers should be checked for identity, integrity of package and seal, and correspondence between the delivery note and the supplier s labels, and for compliance with product quality specifications. 4.2 Pharmaceutical products held in the storage area should be appropriately labelled. There should be appropriate procedures or measures to assure the identity of the contents of each container of the products. 4.3 All pharmaceutical products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation. 4.4 Those products requiring special storage conditions (for example specific temperature and humidity conditions) should be placed in separate areas constructed and equipped to provide the specified conditions. The storage conditions should be continuously monitored and recorded. Packaging Materials 4.5 Materials to be used in secondary packaging, including printed packaging materials, should only be obtained from approved suppliers named in the relevant specification for that material. 4.6 Each delivery or batch of labels and printed packaging materials received should be examined and approved by the Quality Assurance Officer, and given a specific reference number for traceability purposes. Only starting materials which have been released by the Quality Assurance Officer should be used. 4.7 Particular attention should be given to the handling and control of labels and printed packaging materials, including the need for them to be: a. Purchased from approved suppliers named in the relevant specification. b. Stored in adequately secure conditions such as to exclude unauthorized access. c. Stored in separate, closed containers so as to avoid mix ups. d. Issued for use only by authorized personnel following an approved and documented procedure. e. Transported to the secondary packaging area in separate, closed containers so as to avoid mix ups. 4.8 Out dated or obsolete printed packaging material should be destroyed and their disposal recorded. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 7

8 5. GOOD PRACTICES IN SECONDARY PACKAGING 5.1 The appropriate registered particulars of the pharmaceutical products that are subject to secondary packaging should be complied with and, where necessary, the approval of the holder of the Certificate of Drug/Product Registration should be sought if there is any variation to the registered particulars. 5.2 When setting up a program for the secondary packaging operations, particular attention should be given to minimizing the risk of cross contamination, mix ups or substitutions. The secondary packaging of different products should not be carried out in close proximity unless there is physical segregation. 5.3 Special care should be taken when using cut labels and when over printing is carried out off line. Roll feed labels are preferable to cut labels in helping to avoid mix ups. 5.4 Written procedures should be available for the handling of any spillage or breakage involving pharmaceutical products containing highly active substances (e.g. cytotoxics, steroids, hormones, etc.) or highly sensitising substances (e.g. penicillins, cephalosporins, etc.). 5.5 All products and materials used for secondary packaging operations should be checked before use by a designated person for quantity, identity and conformity with the Packaging Instructions. 5.6 Line clearance checks should be performed prior to commencement of each secondary packaging operation. Steps should be taken to ensure that the working area, packaging lines, printing machines and other equipment are clean and free from any products, materials or documents previously used, if these are not required for the current operation. 5.7 Each batch of product produced must be assigned a unique batch number which may incorporate the original manufacturer s batch number and a suffix to identify each separate packaging run. Alternative batch numbering systems that provide full traceability to each packaging run may be accepted. 5.8 The correct performance of any printing operation (for example batch number coding and expiry dating) should be checked and recorded. Attention should be paid to printing by hand which should be re checked at regular intervals. 5.9 Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing On line control of the product during secondary packaging should, where applicable, include checking the following: a. General appearance of packages. b. Completeness of packages. c. Correctness of products and packaging materials used. d. Correctness of over printing, e.g. batch number, expiry date. e. Correctness of supplementary labels applied to products Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it should be approved in writing by the Quality Assurance Officer Any significant or unusual discrepancy observed during reconciliation of the amount of printed packaging materials used and the number of units produced should be investigated and satisfactorily accounted for before release for sale or supply Upon completion of a secondary packaging operation, any unused batch coded packaging materials should be destroyed and their destruction recorded. A documented procedure should be followed if un coded printed materials are returned to stock. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 8

9 5.14 Finished products should be held under quarantine and stored under suitable conditions until their final release. 6. QUALITY CONTROL 6.1 There should be a designated and independent person in charge of Quality Control (QC). This may be the Quality Assurance Officer or another, independent person. 6.2 The identity, authenticity and quality of each batch of pharmaceutical product that is to be the subject of secondary packaging should be verified upon receipt by visual examination of the products and check against documentation such as delivery notes, certificates of analysis, established specifications, as well as the integrity of packaging/seals. These checks should be documented. 6.3 If a valid certificate of analysis is not available for a batch of pharmaceutical product, it should be tested for compliance with established specifications by an appropriately accredited laboratory before it is approved for secondary packaging. 6.4 Where unlabelled containers of pharmaceutical products are received for secondary packaging, the identity of each batch should be verified by representative samples tested by an appropriately accredited laboratory using specific chemical or instrumental techniques (irrespective of the availability of a certificate of analysis for the batch). Furthermore, unlabelled containers of pharmaceutical products should be subject to secondary packaging in a single packaging run to minimise the risk of mix up of remaining unlabelled containers. 6.5 The identity and quality of packaging materials to be used in secondary packaging, including printed packaging materials, should be verified against established specifications. These checks should be documented. 6.6 Finished product assessment should embrace all relevant factors, including production conditions, results of in process testing, a review of packaging documentation, compliance with finished product specification and examination of the final finished pack. 6.7 Reference samples should be representative of the batch of materials or products from which they are taken and should be of a size sufficient to permit at least a full reexamination. 6.8 Reference sample and/or retention samples from each batch of finished products should be retained till one year after the expiry date. Finished product retention samples should be kept in their final packaging and stored under the recommended conditions. Where a batch is packaged in two, or more, distinct packaging operations, at least one retention sample should be taken from each individual secondary packaging operation. 6.9 Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 9

10 7. DOCUMENTATION General Requirements 7.1 Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant statutory requirements for licensed manufacturers and holders of the Certificate of Drug/Product Registration. 7.2 Documents should be approved, signed and dated by appropriate and authorised persons. 7.3 Documents should have unambiguous contents; title, nature and the purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process. 7.4 Documents should be regularly reviewed and kept up to date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents. 7.5 Documents should not be hand written; although, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries. 7.6 Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded. 7.7 The records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the packaging of pharmaceutical products are traceable. 7.8 Batch documentation must be kept for one year after the expiry of the batch to which it relates or at least five years after certification of the batch by the Quality Assurance Officer, whichever is the longer. 7.9 Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorised persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records electronically stored should be protected by back up transfer on magnetic tape, microfilm, paper or other means. It is particularly important that the data are readily available throughout the period of retention. Secondary Packaging Documents 7.10 All packaging materials used in secondary packaging operations should have approved specifications which serve as the basis for quality evaluation by the Quality Assurance Officer upon their receipt Written receipt, release and rejection procedures should be available for materials and products, and in particular for the release for sale or supply of the finished product by the Quality Assurance Officer. Records of receipt, release and rejection should be maintained for materials and products. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 10

11 Packaging Instructions 7.12 There should be formally authorised Packaging Instructions for each product, pack size and type. These should normally include, or have a reference to, the following: a. name of the product; b. description of its pharmaceutical form, and strength where applicable; c. the pack size expressed in terms of the number, weight or volume of the product in the final container; d. a complete list of all the packaging materials required, including quantities, sizes and types, with the code or reference number relating to the specifications of each packaging material; e. where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and shelf life of the product; f. checks that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations (line clearance), and that equipment is clean and suitable for use; g. special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin; h. a description of the packaging operation, including any significant subsidiary operations, and equipment to be used; and i. details of in process controls with instructions for sampling and acceptance limits. Batch Packaging Records 7.13 A Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions. The batch packaging record should contain the following information: a. the name and batch number of the product; b. the date(s) and times of the packaging operations; c. identification (initials) of the operator(s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations; d. records of checks for identity and conformity with the Packaging Instructions including the results of in process controls; e. details of the packaging operations carried out, including references to equipment and the packaging lines used; f. samples of printed packaging materials used, including specimens of the batch coding, expiry dating and any additional overprinting; g. notes on any special problems or unusual events including details, with signed authorisation for any deviation from the Packaging Instructions; h. the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation. Where there are robust electronic controls in place during packaging there may be justification for not including this information; i. approval by the person responsible for the packaging operations. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 11

12 8. STOCK HANDLING AND STOCK CONTROL Stock Rotation and Control 8.1 Comprehensive records should be maintained showing all receipt and issue of products (for secondary packaging) according to batch number. 8.2 Periodic stock reconciliation should be performed comparing the actual and recorded stocks. In any event, this should be performed when each batch is totally used up. All significant stock discrepancies should be subjected to investigation as a check against inadvertent mix ups and wrong issues. 8.3 The issue of products for secondary packaging should normally observe the principle of stock rotation, i.e. first in first out. 8.4 Products with broken seals, damaged packaging or suspected of possible contamination must not be sold or supplied. 8.5 Goods bearing an expiry date must not be received or supplied after their expiry date or so close to their expiry date that this date is likely to occur before the goods are used by the customer. 8.6 All labels and containers of products should not be altered, tampered or changed. The legislative requirements relating to labels and containers for pharmaceutical products should be complied with at all times. Delivery of Finished Products 8.7 Before delivery, each consignment should be checked against the relevant documentation and physically verified by label description, type and quantity, against the order. 8.8 Records should be maintained of the distribution of each batch of the product packaged in order to facilitate the recall of the batch if necessary. 9. REJECTED AND RETURNED GOODS Rejected Goods 9.1 Rejected materials and products should be clearly marked as being rejected and stored separately in a locked area with restricted access. They should be either returned to the suppliers or destroyed. Whatever action is taken should be recorded and approved by the Quality Assurance Officer. 9.2 All pharmaceutical products must be destroyed or disposed of in accordance with the provisions of the relevant legislative requirements. Returned Goods 9.3 There should be a Standard Operating Procedure (SOP) for the handling of returned products. Records of all returns goods should be kept. 9.4 All returned products should be kept apart from saleable stock until a decision has been reached regarding their disposal. 9.5 Products should only be returned to saleable stock if: a. The goods are in their original unopened containers and in good condition; b. It is known that the goods have been stored and handled under proper conditions; c. The remaining shelf life period is acceptable; and Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 12

13 d. The goods have been examined and assessed by the Quality Assurance Officer. This assessment should take into account the nature of the product, any special storage conditions required, and the time which had elapsed since it was distributed. Special attention should be given to thermo labile products. 9.6 The returned products should be formally Assurance Officer. released to the saleable stock by the Quality 10. PRODUCT COMPLAINTS 10.1 An SOP describing the actions to be taken for the handling of all written and oral complaints regarding a product should be available. The SOP should ensure that the complaints received are investigated and followed through, that corrective actions are taken to prevent repeated complaints, and, where a decision is made to recall the product, the details of the recall There should be a record for each individual complaint. Investigations 10.3 The Quality Assurance Officer should initiate the investigation immediately and all investigation should be documented in writing. The investigation should take into consideration the condition and circumstances under which the product was distributed, stored and used If a product defect is discovered or suspected in a batch, consideration should be given to determine whether other batches are also affected An investigation report should be prepared with all corrective/preventive actions clearly stated. 11. PRODUCT RECALL 11.1 There should be an SOP for all urgent and non urgent product recalls In the event of a recall, all customers to whom the product has been distributed should be informed with the appropriate degree of urgency The recall message should indicate whether the recall needs to be carried out at the retail level, and whether there is a need to remove all recalled products immediately from the shelves, and prevent their mixing with other saleable stocks If the product is exported, the overseas counterparts and/or regulatory authorities must be informed of the recall All actions taken in connection with the recall must be approved by the company and/or regulatory authorities, and recorded. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 13

14 12. SELF INSPECTION 12.1 Self inspections should be conducted in order to monitor the implementation and compliance with the requirements of this Guidance Document and to propose necessary corrective measures Personnel matters, premises, equipment, documentation, assembly, quality control, distribution of the pharmaceutical products, arrangements for dealing with complaints and recalls should be examined at intervals following a pre arranged program Self inspections should be conducted in an independent and detailed way by designated competent persons. Independent audits by external experts may also be useful All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded. 13. CONTRACT PACKAGING OR ANALYSIS ARRANGEMENTS 13.1 Where secondary packaging or analysis of pharmaceutical products is carried out under contract, a written contract agreement between the Contract Giver and the Contract Receiver should be available to describe the arrangements and responsibilities of both parties The arrangements and responsibilities for any contracted activities should be consistent with the requirements of Chapter 7 of the PIC/S GMP Guide. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 14

Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products

Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products December 2014 Pharmacy and Poisons Board Pharmacy and Poisons Board of Hong Kong Version 2.1. Contents

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064587 EudraLex The Rules Governing Medicinal Products

More information

Guidance for Industry: Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products

Guidance for Industry: Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products for Industry: Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products Version 2.1 Drug Office Department of Health. Contents PURPOSE... 3 SCOPE... 3 GLOSSARY... 3 GUIDANCE FOR INDUSTRY...

More information

Annex 9 Guide to good storage practices for pharmaceuticals 1

Annex 9 Guide to good storage practices for pharmaceuticals 1 World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals 1 1. Introduction 125 2. Glossary 126 3. Personnel 128 4. Premises and facilities

More information

HONG KONG GOOD MANUFACTURING PRACTICES GUIDELINES FOR PHARMACEUTICAL PRODUCTS PHARMACY AND POISONS BOARD OF HONG KONG

HONG KONG GOOD MANUFACTURING PRACTICES GUIDELINES FOR PHARMACEUTICAL PRODUCTS PHARMACY AND POISONS BOARD OF HONG KONG HONG KONG GOOD MANUFACTURING PRACTICES GUIDELINES FOR PHARMACEUTICAL PRODUCTS 1995 PHARMACY AND POISONS BOARD OF HONG KONG CONTENTS General considerations Glossary Part One: Section 1 Section 2 Section

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Ref. Ares(2013)148102-05/02/2013 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, SANCO/D/6/SF/mg/ddg1.d.6(2013)179367

More information

Example of a food company quality

Example of a food company quality Appendix A manual Example of a food company quality Contents Date: 13/03/95 RME-QLMN-OO Page 1 of 3 Section Title ISO 9001 reference 01 In trod uction 02 Purpose 03 Scope 04 Definitions 05 Management responsibility

More information

Guide to Master Formulae WHO/FWC/IVB/QSS/VQR

Guide to Master Formulae WHO/FWC/IVB/QSS/VQR WHO/FWC/IVB/QSS/VQR 2011 This guidance document GUIDE TO MASTER FORMULAE is one of a series developed by WHO/FWC/IVB Quality, Safety & Standards team upon request from the manufacturers members of the

More information

MINISTRY OF HEALTH ORDINANCE

MINISTRY OF HEALTH ORDINANCE MINISTRY OF HEALTH 1798 Pursuant to Article 74, paragraphs 2 and 3, Article 83, paragraph 5 and Article 89 of the Medicinal Products Act (Official Gazette 76/2013), the Minister of Health hereby issues

More information

of Medicinal Products

of Medicinal Products Code Guidelines of Practice on Good Distribution for QUALIFIED Practices PERSONS of Medicinal Products EUROPEAN INDUSTRIAL PHARMACISTS GROUP GUIDELINES ON GOOD DISTRIBUTION PRACTICES OF MEDICINAL PRODUCTS

More information

GUIDELINE ON GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY PREMIXES (1 ST EDITION)

GUIDELINE ON GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY PREMIXES (1 ST EDITION) GUIDELINE ON GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY PREMIXES (1 ST EDITION) JANUARY 2015 NATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA www.bpfk.gov.my Introduction The implementation

More information

ASEAN GUIDELINE ON GOOD MEDICINES AND HEALTH SUPPLEMENTS MANUFACTURING PRACTICE FOR TRADITIONAL. Version 1

ASEAN GUIDELINE ON GOOD MEDICINES AND HEALTH SUPPLEMENTS MANUFACTURING PRACTICE FOR TRADITIONAL. Version 1 Association of South East Asian Nations (ASEAN) ASEAN GUIDELINE ON GOOD MANUFACTURING PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS Version 1 INTRODUCTION Good Manufacturing Practice (GMP)

More information

ANNEX VIII - ASEAN GUIDELINES ON GOOD MEDICINES AND HEALTH SUPPLEMENTS MANUFACTURING PRACTICE FOR TRADITIONAL. Version 1

ANNEX VIII - ASEAN GUIDELINES ON GOOD MEDICINES AND HEALTH SUPPLEMENTS MANUFACTURING PRACTICE FOR TRADITIONAL. Version 1 Association of South East Asian Nations (ASEAN) ANNEX VIII - ASEAN GUIDELINES ON GOOD MANUFACTURING PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS Version 1 INTRODUCTION Good Manufacturing Practice

More information

Guide to Good Manufacturing Practice of Cosmetic Products

Guide to Good Manufacturing Practice of Cosmetic Products Guide to Good Manufacturing Practice of Cosmetic Products IA-G0048-2 2 APRIL 2016 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS

More information

ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE

ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE APPENDIX VI ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE PREAMBLE The GMP Guidelines have been produced to offer assistance to the

More information

1 OF 6 3. SUBMISSION REQUIREMENTS FOR APPLICATION FOR APPROVAL TO OPERATE A PHARMACEUTICAL BUSINESS

1 OF 6 3. SUBMISSION REQUIREMENTS FOR APPLICATION FOR APPROVAL TO OPERATE A PHARMACEUTICAL BUSINESS 1 OF 6 D R U G S R E G U L A T O R Y U N I T Ministry of Health M i n i s t r y o f H e a l t h H e a d q u a r t e r s F l o o r 3, B l o c k D G o v e r n ment E n c l a ve P / B a g 0 0 3 8 G a b o

More information

Pharmaceutical Wholesaler Site Inspection Checklist

Pharmaceutical Wholesaler Site Inspection Checklist Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:

More information

EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4

EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4 Ref. Ares(2015)283695-23/01/2015 PT CHAPTER 5 PRODUCTION EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy EudraLex

More information

COMMISSION DIRECTIVE 2003/94/EC

COMMISSION DIRECTIVE 2003/94/EC L 262/22 COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal

More information

Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers

Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices ( cgmps or GMPs ) for pharmaceutical manufacturers provide the methods and controls

More information

GUIDELINES FOR IMPLEMTING GMP IN FOOD PROCESSING

GUIDELINES FOR IMPLEMTING GMP IN FOOD PROCESSING GUIDELINES FOR IMPLEMTING GMP IN FOOD PROCESSING 2.Storage Facilities 2.1 Use of off site facilities - are they controlled 2.1.1 Where the manufacturer commissions the services of (or contracts to) off

More information

GOOD MANUFACTURING PRACTICES GUIDANCE DOCUMENT

GOOD MANUFACTURING PRACTICES GUIDANCE DOCUMENT GOOD MANUFACTURING PRACTICES GUIDANCE DOCUMENT Natural Health Products Directorate August 2006 Version 2.0 Our mission is to help the people of Canada maintain and improve their health, while respecting

More information

GUIDELINES TO GOOD MANUFACTURING PRACTICES (G.M.P.) IN PHARMACEUTICAL MANUFACTURING

GUIDELINES TO GOOD MANUFACTURING PRACTICES (G.M.P.) IN PHARMACEUTICAL MANUFACTURING Pakistan Journal of Pharmaceutical Sciences Vol. 8(1), January 1995, pp.63.67 SHORT COMMUNICATION GUIDELINES TO GOOD MANUFACTURING PRACTICES (G.M.P.) IN PHARMACEUTICAL MANUFACTURING RIAZ HUSSAIN SHAIKH

More information

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS 1 WHAT IS A SITE MASTER FILE? A Site Master File (SMF) is a document prepared by the manufacturer containing specific

More information

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013)

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) January 2013 RESTRICTED PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) DRAFT FOR COMMENTS Please address any comments on this proposal

More information

GMP Inspection report

GMP Inspection report Inspected site(s): Activities Carried out: GMP Inspection report Manufacture of Active Substance Manufacture of Finished Medicinal Product Packaging Importing Laboratory Testing Batch Control and Batch

More information

Draft guidance for registered pharmacies preparing unlicensed medicines

Draft guidance for registered pharmacies preparing unlicensed medicines Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies

More information

Annex 5 WHO good distribution practices for pharmaceutical products

Annex 5 WHO good distribution practices for pharmaceutical products World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 5 WHO good distribution practices for pharmaceutical products 1. Introduction 2. Scope of the document 3. Glossary 4. General

More information

GUIDELINES ON GOOD MANUFACTURING PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS FIRST EDITION

GUIDELINES ON GOOD MANUFACTURING PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS FIRST EDITION GUIDELINES ON GOOD MANUFACTURING PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS FIRST EDITION KUALA LUMPUR, MALAYSIA 2008 Guidelines on Good Manufacturing Practice Page 1 of 86 GUIDELINES ON

More information

Annex 2 Good trade and distribution practices for pharmaceutical starting materials

Annex 2 Good trade and distribution practices for pharmaceutical starting materials World Health Organization WHO Technical Report Series, No. 917, 2003 Annex 2 ood trade and distribution practices for pharmaceutical starting materials Introductory note 36 Scope 37 eneral considerations

More information

ISO/IEC 17025 QUALITY MANUAL

ISO/IEC 17025 QUALITY MANUAL 1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4

More information

GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)

GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) MEDICAL DEVICE CONTROL DIVISION Ministry of Health, Malaysia Regulatory Requirements for Medical Device Safety & Performance GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) DRAFT DRAFT 1 September

More information

Synopse: EU-GMP-Leitfaden Kapitel 4 Documentation

Synopse: EU-GMP-Leitfaden Kapitel 4 Documentation Synopse: EU-GMP-Leitfaden Kapitel 4 Documentation Am 3. Januar 2011 wurde die neue Fassung 4 Documentation durch die Europäische Kommission freigegeben. Das Kapitel wurde vollständig überarbeitet und viele

More information

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Safeguarding public health New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Tony Orme, Senior GDP Inspector Inspection, Enforcement and Standards Division

More information

Food Safety and Quality Management System

Food Safety and Quality Management System Introduction The company has planned, established, documented and implemented a food safety and quality management system for the site, which is maintained in order to continually improve its effectiveness

More information

Version 1.0 November 2013 Developed by: Working group of the HPAI Aseptic Services Special Interest Group (ASSIG)

Version 1.0 November 2013 Developed by: Working group of the HPAI Aseptic Services Special Interest Group (ASSIG) (H-PIC\S) Version 1.0 November 2013 Developed by: Working group of the HPAI Aseptic Services Special Interest Group (ASSIG) The working group of the HPAI ASSIG was chaired by: Aisling Collins BSc (Pharm),

More information

[SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS.

[SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. [SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. Note: - To achieve the objectives listed below, each

More information

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments:

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: Sample SUPPLIER AUDIT REPORT Supplier / Factory Name: Address: Date of Visit: Tel: Fax: Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: The suppliers signature

More information

Community Guide to Good Practice For Feed Additive and Premixture Operators

Community Guide to Good Practice For Feed Additive and Premixture Operators Community Guide to Good Practice For Feed Additive and Premixture Operators INTRODUCTION This European Guide of Practice for Animal Feed Additive and Premixture Operators ( Guide ) responds to the Regulation

More information

Producing, Storing and Supplying Animal Feeds

Producing, Storing and Supplying Animal Feeds Producing, Storing and Supplying Animal Feeds EC Feed Hygiene Regulation (183/2005) The Feed Hygiene Regulation (EC 183/2005) came into effect on the 1st January 2006. The Regulation applies to businesses

More information

Guide to Quality System for General Sale Wholesale Distributors

Guide to Quality System for General Sale Wholesale Distributors Guide to Quality System for General Sale Wholesale Distributors IA-G0038-2 1 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.

More information

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005)

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,

More information

SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS

SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS GAZETTE OF INDIA EXTRAORDINARY, PART II-SECTION 3, SUB-SECTION (i)] MINISTRY OF HEALTH

More information

Annex 2. WHO good manufacturing practices for pharmaceutical products: main principles 1

Annex 2. WHO good manufacturing practices for pharmaceutical products: main principles 1 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and

More information

Summary of ISO additional requirements

Summary of ISO additional requirements ISO 15189:2012 Clause 4.1.1.3.d 4.1.1.4 4.1.2.1h 4.1.2.4 4.2.1 4.3 4.6 4.9 4.1 4.11 4.13 Summary of ISO 15189 additional requirements Ethical conduct Procedures to deal with disposal of human samples,

More information

RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE. Quality Manual

RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE. Quality Manual RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Quality Manual AS9100 & ISO9001: 2000 NTI/QM/001 CONTENTS Clauses of the standard Pg. # 1. Scope 4 1.1 General 4 1.2 Permissible exclusions 4

More information

ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE

ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE THIS POLICY OUTLINES THE TOP LEVEL REQUIREMENTS TO SUPPORT PRODUCT QUALITY IN THE DEVELOPMENT, MANUFACTURE AND DISTRIBUTION OF ACTIVE PHARMACEUTICAL

More information

Site visit inspection report on compliance with HTA minimum standards. Belfast Cord Blood Bank. HTA licensing number 11077.

Site visit inspection report on compliance with HTA minimum standards. Belfast Cord Blood Bank. HTA licensing number 11077. Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export

More information

Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles

Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles Introduction 37 General considerations 39 Glossary

More information

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066 Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of

More information

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205 www.schweppesaustralia.com.au Quality Management Systems 1. Quality Management Systems develop, implement, verify

More information

MANUAFACTURERS AND WHOLESALERS CHAPTER TABLE OF CONTENTS

MANUAFACTURERS AND WHOLESALERS CHAPTER TABLE OF CONTENTS MANUAFACTURERS AND WHOLESALERS CHAPTER 1140-9 (Rule 1140-9-.05, continued) RULES OF THE TENNESSEE BOARD OF PHARMACY Formatted CHAPTER 1140-9 MANUFACTURERS AND WHOLESALERS/DISTRIBUTORS TABLE OF CONTENTS

More information

GOOD DRUG STORAGE AND DISTRIBUTION APPROVED CODE OF PRACTICE (ACOP) FOR HEALTHCARE OPERATORS

GOOD DRUG STORAGE AND DISTRIBUTION APPROVED CODE OF PRACTICE (ACOP) FOR HEALTHCARE OPERATORS GOOD DRUG STORAGE AND DISTRIBUTION APPROVED CODE OF PRACTICE (ACOP) FOR HEALTHCARE OPERATORS GSDP ACOP 1 of 17 Jun09 Table of Contents 1 Section 1: Introduction... 3 2 Section 2: Applicability... 4 3 Section

More information

Working Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice

Working Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex

More information

Quality Information. Buchs Manufacturing Site

Quality Information. Buchs Manufacturing Site Buchs Manufacturing Site Related Documents Buchs ISO 9001:2008 Certificate Buchs cgmp Certificate Buchs ISO 13485:2012 Certificate Buchs ISO 17025:2005/ ISO Guide 34 Certificate Buchs Management System

More information

PRODUCT CERTIFICATION REQUIREMENTS

PRODUCT CERTIFICATION REQUIREMENTS PRODUCT CERTIFICATION REQUIREMENTS SIRIM QAS International Product Certification Page 1 of 14 QUALITY SYSTEM 1. GENERAL 1.1 This document defines the responsibilities and obligations of the Licensee with

More information

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc.

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration & Preventative Maintenance Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration: A comparison of two instruments or measuring devices one of which is a standard of known

More information

Annex 4. Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection

Annex 4. Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection Annex 4 Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection 1. Introduction 294 2. Purpose 294 3. Scope 294 4. Assessment tool 295 293 WHO

More information

"How to do"- Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE

How to do- Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE Cefic/APIC "How to do" Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE GDP for APIs: How to do Document Interpretation of the WHO Guideline GOOD TRADE AND DISTRIBUTION PRACTICES FOR PHARMACEUTICAL

More information

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006 Basic Understanding of Good Manufacturing Practices Requirements and Execution Minda Chiang Hong Kong Society for Quality Jan 2006 1 Outline 1 To know why GMP 2 To know what GMP is 3 To know how to comply

More information

E- Mail:

E- Mail: Company Registered Number: 5045144 VAT Registration Number: 833 2781 27 Contact Name: Ian Parris Company Address: Units 1-6 The Old Station Higham Bury St Edmunds Suffolk IP28 6NL Tel: 01284 812520 Fax:

More information

HOKLAS Supplementary Criteria No. 40

HOKLAS Supplementary Criteria No. 40 Page 1 of 10 HOKLAS Supplementary Criteria No. 40 Chinese Medicine Test Category Identification of Chinese Materia Medica by Microscopic Examination in accordance with the Hong Kong Chinese Materia Medica

More information

Guide to Good Distribution Practice of Medicinal Products for Human Use

Guide to Good Distribution Practice of Medicinal Products for Human Use Guide to Good Distribution Practice of Medicinal Products for Human Use IA-G0046-2 10 APRIL 2014 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes

More information

BRC/IoP Global Standard

BRC/IoP Global Standard BRC/IoP Global Standard Food Packaging and Other Packaging Materials A guide to the revisions contained in Issue 2 of the Standard The purpose of this guide is to help companies obtain a quick overview

More information

BRC Food Safety and Quality Management System. New Issue 7

BRC Food Safety and Quality Management System. New Issue 7 New Issue 7 This is an ideal package for Food Manufacturers looking to meet BRC Global Standard for Food Safety (Issue 7 2015) for Food Safety Quality Management Systems. Our BRC Food Safety Quality Management

More information

HSB REGISTRATION SERVICES ISO 9001:2000 AUDIT CHECKLIST

HSB REGISTRATION SERVICES ISO 9001:2000 AUDIT CHECKLIST HSB REGISTRATION SERVICES ISO 9001:2000 AUDIT CHECKLIST COMPANY NAME: AUDIT LOCATION: AUDIT DATE(S): EAC CODE: AUDIT SCOPE: Exclusions / Notes: AUDIT TEAM INFORMATION: Lead Auditor: Auditor(s): ISO FO

More information

Recent Updates on European Requirements and what QPs are expected to do

Recent Updates on European Requirements and what QPs are expected to do Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status

More information

Company Quality Manual Document No. QM Rev 0. 0 John Rickey Initial Release. Controlled Copy Stamp. authorized signature

Company Quality Manual Document No. QM Rev 0. 0 John Rickey Initial Release. Controlled Copy Stamp. authorized signature Far West Technology, Inc. ISO 9001 Quality Manual Document No.: QM Revision: 0 Issue Date: 27 August 1997 Approval Signatures President/CEO Executive Vice President Vice President/CFO Change Record Rev

More information

Checklist. Standard for Medical Laboratory

Checklist. Standard for Medical Laboratory Checklist Standard for Medical Laboratory Name of hospital..name of Laboratory..... Name. Position / Title...... DD/MM/YY.Revision... 1. Organization and Management 1. Laboratory shall have the organizational

More information

Guidelines for drafting a Site Master File (SMF)

Guidelines for drafting a Site Master File (SMF) Guidelines for drafting a Site Master File (SMF) A Site Master File for each manufacturing site listed in a product dossier, must be submitted to World Health Organization, HTP/EDM/QSM, 20 Ave Appia, 1211

More information

EAEPC Good Parallel Distribution Practice Guidelines for Medicinal Products

EAEPC Good Parallel Distribution Practice Guidelines for Medicinal Products EAEPC Good Parallel Distribution Practice Guidelines for Medicinal Products Due to its role in the production and handling of products related to public health, the Community pharmaceutical sector operates

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL

More information

EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE

EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE TABLE OF CONTENTS Page 1. Document History... 1 2. Introduction... 1 3. Purpose... 2 4. Scope... 2 5. Site Master File... 2

More information

Version 6.0. FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing, Documenting, Implementing, Maintaining and Auditing the Program (Edition 6.

Version 6.0. FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing, Documenting, Implementing, Maintaining and Auditing the Program (Edition 6. Version 6.0 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing, Documenting, Implementing, Maintaining and Auditing the Program (Edition 6.0) PREFACE FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing,

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal

More information

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September

More information

11 MEDICATION MANAGEMENT

11 MEDICATION MANAGEMENT 1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,

More information

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES UOW SAFE@WORK WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES HRD-WHS-GUI-213.8 WHS Auditing Guidelines 2016 September Page 1 of 17 Contents 1 Purpose... 1 2 Scope... 1 3 Definitions... 1 4 Responsibilities...

More information

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and

More information

CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS

CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS Overview 6.1 This chapter sets out the Review Committee s findings and recommendations on procurement

More information

White paper: The 10 Golden Rules of GMP

White paper: The 10 Golden Rules of GMP White paper: The 10 Golden Rules of GMP The Good Manufacturing Practice regulations that govern pharmaceutical and medical device manufacturing can seem overwhelming. Use these ten golden rules to drive

More information

Guide to Distribution of Cosmetic Products in Ireland

Guide to Distribution of Cosmetic Products in Ireland Guide to Distribution of Cosmetic Products in Ireland ADV-G0012-2 17 JUNE 2013 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS

More information

State Meat and Poultry Inspection (MPI) Program Laboratory Quality Management System Checklist

State Meat and Poultry Inspection (MPI) Program Laboratory Quality Management System Checklist This checklist is intended to help laboratories improve the quality of their testing programs with regard to meat and poultry testing samples, in order to ensure those laboratories are at least equal to

More information

Annex 7 Guidelines on pre-approval inspections

Annex 7 Guidelines on pre-approval inspections World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the

More information

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES WHS UNIT WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES Contents 1 Purpose... 1 2 Scope... 1 3 Definitions... 1 4 Responsibilities... 1 4.1 WHS Unit... 1 4.2 Auditor(s)... 1 4.3 Managers of Faculties

More information

Supplier Requirements Packaging

Supplier Requirements Packaging Purpose To ensure packaging suppliers are aware of The Coca-Cola Company requirements for quality and food safety. These requirements support the Coca-Cola supplier authorization process, including facility

More information

Audits must be conducted with due concern for employee safety and environmental protection.

Audits must be conducted with due concern for employee safety and environmental protection. Standard Operating Procedure Title: GMP Audit Procedure Related Documents TEM-080 Internal Audit Report Template TEM-120 Vendor Audit Report Template Form-385 Vendor Audit Questionnaire Form-445 EHS Workplace

More information

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS About this document This document is a guide to show what the Inspectorate may look for during an inspection visit. It is intended for use by the GPhC

More information

Quality Management System Manual

Quality Management System Manual Quality Management System Manual Assurance ISO / AS Manual Quality Management System EXCEEDING ALL EXPECTATIONS Since our inception in 1965, Swiss-Tech has supplied the medical, aerospace, hydraulic, electronic

More information

ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. Step 5

ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. Step 5 European Medicines Agency November 2000 CPMP/ICH/4106/00 ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 NOTE FOR GUIDANCE ON GOOD MANUFACTURING PRACTICE FOR ACTIVE

More information

- 1 - First Time Pharmacy Managers (Revised 02/02/2011)

- 1 - First Time Pharmacy Managers (Revised 02/02/2011) State of Connecticut Department of Consumer Protection Commission of Pharmacy 165 Capitol Avenue, Room 147 Hartford, CT 06106 - Telephone: 860-713-6070 ALL FIRST-TIME PHARMACY MANAGERS ARE REQUIRED TO

More information

Standards for pharmacy owners, superintendent pharmacists and pharmacy professionals in positions of authority

Standards for pharmacy owners, superintendent pharmacists and pharmacy professionals in positions of authority Standards for pharmacy owners, superintendent pharmacists and pharmacy professionals in positions of authority April 2010 Standards for pharmacy owners, superintendent pharmacists and pharmacy professionals

More information

Quality Management System Policy Manual

Quality Management System Policy Manual Quality Management System Burns Engineering, Inc. 10201 Bren Road East Minnetonka, MN 55343 4. 4.1 General Requirements The Quality Manual consists of the quality system policy documents and the quality

More information

GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS

GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE Working document QAS/04.068/Rev.2 RESTRICTED GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS This document has followed the steps

More information

Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK

Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK Report of an accreditation event, 19 November 2010 Introduction The General Pharmaceutical Council (GPhC) is the statutory regulator

More information

UNICEF s Quality Assurance System for procurement of medicines

UNICEF s Quality Assurance System for procurement of medicines UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September

More information

NC General Statutes - Chapter 106 Article 12A 1

NC General Statutes - Chapter 106 Article 12A 1 Article 12A. Wholesale Prescription Drug Distributors. 106-145.1. Purpose and interpretation of Article. This Article establishes a State licensing program for wholesale distributors to enable wholesale

More information

Sample Food Safety Audit Checklist

Sample Food Safety Audit Checklist Sample Internal Food Safety Audit The purpose of this audit is for the Co-ordinator to conduct an assessment of hygiene standards in all aspects of the food handling procedures carried out in the facility

More information

GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS

GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS SECTION 1 SCOPE CAC/GL 47-2003 1. This document provides a framework for the development and operation of an import control system to protect consumers and facilitate

More information

This guide describes the core components of a SMF suitable for a company holding an importer s or wholesaler s licence.

This guide describes the core components of a SMF suitable for a company holding an importer s or wholesaler s licence. Introduction The purpose of the SMF is to provide the Inspector with an introduction to the company and its activities prior to the commencement of the inspection and to demonstrate to the Inspector that

More information