Process Validation of Sterile Liquid Products

Size: px
Start display at page:

Download "Process Validation of Sterile Liquid Products"

Transcription

1 Process Validation of Sterile Liquid Products By Weerayut Chirarutsami 23/08/2006 1

2 Process Validation Process validation is establishing documented evidence which demonstrate that the manufacturing process will consistently produce a product meeting its predetermined specifications and quality Characteristics. New Product <==> Trial Batch, Development Batch Transferred Product <==> Products produced at the sending site Revalidation Product <==> The original product before revalidation 2

3 Process Validation Type of Process Validation Prospective Conducted prior to market the product Concurrent Based on information generated during actual implementation of the process (each batch will be released separately) Retrospective (Not recommended for sterile product) Based on accumulated historical production, testing and control data Generally requires data from batches Use data only from batches made by the same process 3

4 Sterile Product : The Products which free of any viable organisms. Sterility : Viable microorganisms are absent. Bioburden : Total number of viable microorganisms on or in pharmaceutical product prior to sterilization. 4

5 Terminal Sterilization : Operation whereby the product is sterilized separately by autoclave after filled and packaged using sterilized containers and closures in critical processing zones. Aseptic Operation: Operation whereby the product is sterilized separately by filtering through 0.2 µ or less filter, then filled and packaged using sterilized containers and closures in critical processing zones. 5

6 Validation Team: Production, QC, QA, Engineer,Planner To prepare the validation protocol Verify the calibration and maintenance status of equipment Perform qualification for equipments and system Verify change control Schedule the validation activities Training production operators Conduct validation study Monitor the critical steps in manufacturing process Assure that the approved testing standard is being used Evaluate all test results, Prepare the validation report. 6

7 Pre-validation Requirements : Preventive Maintenance for Facilities and Utilities Calibration of Equipment Cleaning Validation Equipment & System Qualification Raw Materials/Components/Test Methods Process Justification Change Control Training operators All must be proven suitable and reliable for the manufacturing process before the process can be validated 7

8 Process Justification: To identify critical process steps & process parameter of Mixing process To determine the suitable Hold time Period To confirm the analytical tests that will have to be performed To define the optimal parameters throughout the overall ampoule filling process to consistently produce the finished products(filled ampoules) which meet the established specifications. To assure that the product is sterile after sterilization process 8

9 Validation Protocol A document stating how validation will be conducted, including test parameters, product characteristics, production equipment to be used and decision points on what constitutes acceptable test results 9

10 Validation Protocol should contain : Title Page, Review/Approval Page Purpose and Overview Equipment List Ingredients and Component List Qualification List of Equipment and System Process Flow Diagram and Description Equipment Critical Process Parameter Process Validation Sampling Plan/Testing Requirements Acceptance Criteria Stability Requirements Process for evaluation of any deviations occurring during validation Conclusion 10

11 Equipment Critical Process Parameter: Mixing Speed Mixing Time Gas flushing time Type and size of filter Filtering Time and Pressure used Filling Speed Temperature and Duration for Terminal Sterilization Critical Manufacturing Step Dissolving Step ph adjustment step Final mixing step Filtering Step Filling Step Terminal Sterilization Step Leak Test Step 11

12 Critical Processing Parameter Mixing Speed Mixing Time Flushing Time ph 12

13 Critical Processing Steps Dissolved Active Ingredient ph Adjustment Final Mixing Filtration Filling Sterilization 13

14 Acceptance Criteria Dissolved Active Ingredient Clear Solution ph Adjustment ph with in specification Final Mixing ph, Appearance, Assay Content, Bioburden, Holdtime Filtration Filter Integrity, Sterility, ph, Holdtime 14

15 Acceptance Criteria Filling Sterilization Appearance, Bioburden, Holdtime, Oxygen Headspace Sterility, Assay, ph, Endotoxin etc. Leak Test No. of Leaked products Visual Inspection No. of Defected products 15

16 Product Testing Validation testing of bulk and F/G must be based on testing standard release criteria and in-process testing criteria Typically involves non-routine sampling/testing throughout the entire process, with special emphasis on critical process parameters. Routine QC release testing should be performed on a routine sample. These samples should be taken separately from the validation samples. 16

17 Validation Batch: New product and product transfer, Prospective validation is required Manufacturing Process, Formula, Equipment and Batch Size have to be fixed during the validation trials. Batch Size should be the same size as commercial production batch The batch size must be fixed for production. Different lots but same manufacturer of active ingredients should be used during validation trials. 17

18 Validation Batch: Bulk Sampling and Testing Samples may be taken by Collecting during Transfer Using a sampling device Take at least 2 samples at top, middle and bottom Individual Testing of sample must be done and the result must meet the testing standard specification 18

19 Qualification of Maximum Bulk Hold Time The maximum period of time which the bulk can be held prior to filter, Fill and/or Sterilization It will be counted after finished final mixing step until transfer to filter, finished filter until start filling and/or finished filling until start sterilization One full scale batch should be held for most practical maximum time period prior to filter, fill and/or sterilization If there is not enough support information / qualification done. The period of 24 hours will be used Hold time qualification must simulate actual storage condition 19

20 Finish Product Testing after Sterilization Uniformity of filled volume Perform testing on filled containers. Sterility 10 samples from each of the beginning and end of the filling run. Samples must represent all filling nozzles. Visual Evaluation Appearance, Color of solution Other Testing Assay, ph, Density, Pyrogen or Endotoxin etc. 20

21 Validation Report Validation Team must prepare the report Report must be reviewed and approved by QA. Written Notification or either successful completion or failure of the process validation must be issued to top management. In case of failure, an investigation must be completed and documented prior to repeat the validation study. 21

22 Changes and Revalidation Change of any of the following may need revalidation Formula Composition Raw Material Source Manufacturing Process Manufacturing Location Equipments Batch Size Testing Specification 22

23 Changes Minor: It seems to have no impact on formulation It is not necessary to validate Intermediate : It could have significant impact on formulation Depend on case-by-case (A minimum of 1 trial) Major : It is likely to have significant impact on formulation Revalidation is required (A minimum of 3 trials) 23

24 Minor Change Qualitative inactive excipient change deemed minor by change control review Process change deemed minor by change control review Manufacturing location change with in same building, same equipment, personnel, procedure and utilities are used Equipment change but same design, configuration 24

25 Intermediate Change Active ingredient source or synthesis change deemed intermediate by change control review Qualitative inactive excipient change deemed intermediate by change control review Manufacturing location change to a different building on the same site and same utilities, same equipment, personnel, and procedure are used 25

26 Intermediate Change Process changes, such as mixing times or operating speeds for solutions. Change in release specification to a tighter limit caused original validation results to be out of specification Extension of the qualified in process hold time for intermediate or finished product prior to packaging Equipment change deemed intermediate by change control review 26

27 Major Changes Quantitative or qualitative formulation change deemed major by change control review Inactive excipient or active ingredient source change deemed major by change control review Transfer product from on site to another Significant change in process Equipment change to a different design, configuration or operating principle. 27

28 Major Changes New Dosage Rework Procedure Process changes deemed major by change control review such as mixing times or operating speeds for suspensions. Change in release specification to a tighter limit caused original validation results and routine production results to be out of specification 28

29 Conclusion Validation Protocol identifies critical process parameters to be evaluated and predetermined acceptance criteria Process must be continually monitored and change control used to identify need for process revalidation Production and QA have to review and approve the validation result Product must be held until the validation get approval 29

30 Re-validation Regular performance of process simulation studies Monitoring of environment, disinfection procedures, equipment cleaning and sterilisation (including containers and closures) Routine maintenance and re-qualification of equipment, e.g. autoclaves, ovens, HVAC (heating, ventilation and air conditioning) systems, water systems, etc. Regular integrity testing of product filters, containers, closures and vent filters Re-validation after changes 30

31 Process simulation studies (media fills) Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media. Simulations are made to ensure that the regular process for commercial batches repeatedly and reliably produces the finished product of the required quality. However, each process simulation trial is unique and so it is not possible to extrapolate these results directly to actual production contamination rates. 31

32 Process simulation studies (media fills) Where filling takes place over extended periods, i.e. longer than 24 hours, the process simulation test should extend over the whole of the standard filling period. In order to prevent excessively high numbers of units being filled it is usually acceptable to just run the machine for a reasonable time, if the validity of the simulation is not diminished by this procedure. The fill volume of the containers should be sufficient to enable contact of all the container-closure seal surfaces when the container is inverted and also sufficient to allow the detection of microbial growth. 32

33 Process simulation studies (media fills) Where filling takes place over extended periods, i.e. longer than 24 hours, the process simulation test should extend over the whole of the standard filling period. In order to prevent excessively high numbers of units being filled it is usually acceptable to just run the machine for a reasonable time, if the validity of the simulation is not diminished by this procedure. The fill volume of the containers should be sufficient to enable contact of all the container-closure seal surfaces when the container is inverted and also sufficient to allow the detection of microbial growth. 33

34 Process simulation studies (media fills) Incubation Temperature It is generally accepted to incubate at C for a minimum of 14 days without having collected data to support this incubation schedule. It is similarly acceptable for firms who prefer a two temperature incubation schedule to incubate at C for a minimum of 7 days followed immediately by incubation at a higher temperature range not to exceed 35 C for a total minimum incubation time of 14 days. 34

35 Process simulation studies (media fills) Acceptance Criteria Ideally the contamination rate should be zero. However currently the accepted contamination rate should be less than 0.1 % with a 95 % confidence level according to the Annex I to the EU/PIC/S Guide to GMP. 35

36 Acceptance Criteria FILL MUST MEET THE ACCEPTANCE LIMITS FROM THE FOLLOWING TABLE: MAXIMUM ACCEPTABLE CONTAMINATED UNITS NUMBER OF GOOD OBSERVED IN THE LOT VIALS INCUBATED

VALIDATION OF ASEPTIC PROCESSES

VALIDATION OF ASEPTIC PROCESSES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 007-6 1 January 2011 RECOMMENDATION ON THE VALIDATION OF ASEPTIC PROCESSES PIC/S January 2011 Reproduction prohibited

More information

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control

More information

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 In-process control In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 Here you will find answers to the following questions: What are the in-process control tasks? Where

More information

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION 1 US FDA Form 483: A Case Study DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION DEVELOPED BY FRAN RABE 2 Introduction This case study is intended to extract portions of information

More information

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 *

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PS/INF 11/2015 1 April 2015 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * * Entry into force:

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

Media fills Periodic performance qualification (Re-Validation)

Media fills Periodic performance qualification (Re-Validation) Media fills Periodic performance qualification (Re-Validation) Minimum number of Simulations Number of units Contaminated Units Action a Two per Year (Retrospective & Prospective Validation) < 5000 5000

More information

Microbiology and Auditing. Don Singer

Microbiology and Auditing. Don Singer Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning

More information

FDA and the Compounding Pharmacy

FDA and the Compounding Pharmacy FDA and the Compounding Pharmacy Scott Sutton, Ph.D. scott.sutton@microbiol.org 41 Overview of Presentation The Recent Events GCP and GMP Basics the 483 Review H.R. 3204 Outsourcing Facility Preparation

More information

GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS

GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 032-2 8 January 2010 RECOMMENDATION GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE

More information

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

Annex 4 Supplementary guidelines on good manufacturing practices: validation

Annex 4 Supplementary guidelines on good manufacturing practices: validation World Health Organization WHO Technical Report Series, No. 937, 2006 Annex 4 Supplementary guidelines on good manufacturing practices: validation 1. Introduction 2. Scope 3. Glossary 4. Relationship between

More information

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services

More information

*XLGHIRULQVSHFWLRQRI PDQXIDFWXUHUVRIELRORJLFDOSURGXFWV

*XLGHIRULQVSHFWLRQRI PDQXIDFWXUHUVRIELRORJLFDOSURGXFWV WHO/VSQ/97.03 Original: English Distribution: General *XLGHIRULQVSHFWLRQRI PDQXIDFWXUHUVRIELRORJLFDOSURGXFWV 3UHSDUHGE\*LOOLDQ&KDORQHU/DUVVRQ3K'*&/%LRFRQVXOW 2WWDZD&DQDGD /LQNWR&RQWHQWVSDJH GLOBAL PROGRAMME

More information

Case Study Neubau einer Parenteralia Fabrik 3. GMP-Forum, Kirchzarten 28. September 2012, Basel. Philip Schneider, F.

Case Study Neubau einer Parenteralia Fabrik 3. GMP-Forum, Kirchzarten 28. September 2012, Basel. Philip Schneider, F. 3. GMP-Forum, Kirchzarten 28. September 2012, Basel Philip Schneider, F. Hoffmann-La Roche Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing

More information

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Guidance for Industry Current Good Manufacturing Practice Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act DRAFT GUIDANCE This guidance document is

More information

[See Rules 74,74-A, 74-B, 78 and 78-A] A. SUBSTANCES OTHER THAN PARENTERAL IN PREPARATIONS IN GENERAL

[See Rules 74,74-A, 74-B, 78 and 78-A] A. SUBSTANCES OTHER THAN PARENTERAL IN PREPARATIONS IN GENERAL 29 [SCHEDULE U [See Rules 74,74-A, 74-B, 78 and 78-A] I. Particulars to the shown in /manufacturing Records A. SUBSTANCES OTHER THAN PARENTERAL IN PREPARATIONS IN GENERAL 1. Serial number. 2. Name of the

More information

Particle Monitoring Requirements in Pharmaceutical Cleanrooms

Particle Monitoring Requirements in Pharmaceutical Cleanrooms Particle Monitoring Requirements in Pharmaceutical Cleanrooms All drugs must be manufactured in accordance with the current Good Manufacturing Practice (cgmp) regulations. Pharmaceutical manufacturers

More information

Guideline on Process Validation

Guideline on Process Validation 1 2 3 4 29 March 2012 EMA/CHMP/CVMP/QWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 Draft Draft Agreed by CHMP /

More information

SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES (GMP): VALIDATION

SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES (GMP): VALIDATION WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE Working document QAS/03.055/Rev.2 RESTRICTED SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES (GMP): VALIDATION This document has followed

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

PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION

PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION April 2013 RESTRICTED 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES:

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

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

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union. EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 03 February 2010 ENTR/F/2/AM/an D(2010) 3374 EudraLex The Rules Governing Medicinal Products in

More information

AN OVERVIEW OF PHARMACEUTICAL VALIDATION: QUALITY ASSURANCE VIEW POINT

AN OVERVIEW OF PHARMACEUTICAL VALIDATION: QUALITY ASSURANCE VIEW POINT INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY Available online at www.ijrpc.com Review Article AN OVERVIEW OF PHARMACEUTICAL VALIDATION: QUALITY ASSURANCE VIEW POINT L. Nandhakumar*, G. Dharmamoorthy,

More information

ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products

ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/380/95 ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products

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

Aseptic preparations, including TPN, for a limited number of patients

Aseptic preparations, including TPN, for a limited number of patients Aseptic preparations, including TPN, for a limited number of patients Group F (TPN) 1 Objective Presentation of our business case: setting up an aseptic TPN production in the Hilton Pharmacy instead of

More information

Cleaning validation of cleanrooms and preparation equipments

Cleaning validation of cleanrooms and preparation equipments Cleaning validation of cleanrooms and preparation equipments Head of production Central Pharmacy, Geneva University Hospitals EAHP Foundation Seminar: Patient Safety; More About Compounding" 23-25 May,

More information

Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants

Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants September 1999 Table of contents 1. Foreword...... 2 2. Objective...... 3 3. Scope........ 4 4. Potential residues... 5 5. Current

More information

GMP AUDIT CHECKLIST (AS PER WHO GUIDELINES) Page 1 of 32 INSPECTION OF:

GMP AUDIT CHECKLIST (AS PER WHO GUIDELINES) Page 1 of 32 INSPECTION OF: GMP AUDIT CHECKLIST (AS PER WHO GUIDELINES) Page 1 of 32 Full Address of Company: Products manufactured Location of production Inspection type: mark all that apply external { } routine { } concise { }

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

GENERAL GUIDANCE FOR INSPECTORS ON HOLD-TIME STUDIES

GENERAL GUIDANCE FOR INSPECTORS ON HOLD-TIME STUDIES February 2013 RESTRICTED GENERAL GUIDANCE FOR INSPECTORS ON HOLD-TIME STUDIES DRAFT FOR COMMENT Should you have any comments on the attached text, please send these to Dr Sabine Kopp, Manager, Medicines

More information

Steam Sterilization and the 2007 Revision of PDA Technical Report 1

Steam Sterilization and the 2007 Revision of PDA Technical Report 1 Steam Sterilization and the 2007 Revision of PDA Technical Report 1 14 November 2007 Presented By: Mike Finger (Tunnell Consulting) Don Drew (Abbott Bioresearch Center) Agenda: Introduction Sterilization

More information

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the

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 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION

More information

Expectations for Data to Support Clinical Trial Drugs

Expectations for Data to Support Clinical Trial Drugs Expectations for Data to Support Clinical Trial Drugs Presentation to: APEC Advanced Workshop on Review of Drug Development in Clinical Trials Bangkok Thailand Feb 2-6 2009 Willem Stevens Ph.D., Chief

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

Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant

Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives Barry A. Friedman, Ph.D. Consultant FDA Overview FDA is a consumer protection agency within the Department of Health & Human

More information

Cleanroom. For. Sterile Manufacturing Facilities

Cleanroom. For. Sterile Manufacturing Facilities Cleanroom For Sterile Manufacturing Facilities Praphon Angtrakool Food and Drug Administration 1 WHO TRS No. 823 Annex 1, 1992 (1) General 17.1 The production of sterile preparations should be carried

More information

ISSN 2347-9531 (Print)

ISSN 2347-9531 (Print) Scholars Academic Journal of Pharmacy (SAJP) Sch. Acad. J. Pharm., 2014; 3(2): 178-190 Scholars Academic and Scientific Publisher (An International Publisher for Academic and Scientific Resources) www.saspublisher.com

More information

GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS

GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS MAIN PRINCIPLES First Edition, 2014 Addis Ababa, Ethiopia

More information

Guidance on Qualification of existing facilities, systems, equipment and utilities

Guidance on Qualification of existing facilities, systems, equipment and utilities QUALIFICATION_EXISTING_EQUIPMENT_FINAL page 1 / 16 1. Acknowledgement...3 2. Introduction...3 3. Scope...4 4. Regulatory requirements...4 5. Guidance...4 5.1 Risk Assessment... 4 5.2 Procedure... 7 5.3

More information

Manufacturing process of biologics

Manufacturing process of biologics Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:

More information

Guideline on stability testing for applications for variations to a marketing authorisation

Guideline on stability testing for applications for variations to a marketing authorisation 21 March 2014 EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on stability testing for applications

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products For questions on the content of the guidance,

More information

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1)

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY

More information

Annex 6. Guidance on variations to a prequalified product dossier. Preface

Annex 6. Guidance on variations to a prequalified product dossier. Preface Annex 6 Guidance on variations to a prequalified product dossier Preface This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifi

More information

Environmental Water Testing: Surface Water, Groundwater, Hard Water, Wastewater, & Seawater

Environmental Water Testing: Surface Water, Groundwater, Hard Water, Wastewater, & Seawater Document: AND Sol Env 08 2013 Environmental Water Testing: Surface Water, Groundwater, Hard Water, Wastewater, & Seawater Matrix specific sample preparation and testing methods for environmental waters

More information

Journal of Chemical and Pharmaceutical Research

Journal of Chemical and Pharmaceutical Research Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(2):892-898 World Health Organization s Guidelines for

More information

White paper: FDA Guidance for Industry Update Process Validation

White paper: FDA Guidance for Industry Update Process Validation White paper: FDA Guidance for Industry Update Process Validation In January 2011, the FDA released the final version of its long-awaited update to its Process Validation Guidance for Industry. Since then,

More information

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of

More information

Sterile Cleanroom Management

Sterile Cleanroom Management Sterile Cleanroom Management Lynn Stanard, Sr. Quality Manager, Berkshire Corporation When manufacturing in an aseptic environment, it is critical to ensure that the various cleanroom consumables, such

More information

Elastomeric Components for Pharmaceutical Applications - Actual Quality Trends - Claudia Petersen. -Senior Manager Biotechnology-

Elastomeric Components for Pharmaceutical Applications - Actual Quality Trends - Claudia Petersen. -Senior Manager Biotechnology- Elastomeric Components for Pharmaceutical Applications - Actual Quality Trends - Claudia Petersen -Senior Manager Biotechnology- 2005 by West Pharmaceutical Services, Inc., Lionville, PA All rights reserved.

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Q2B Validation of Analytical Procedures: Methodology November 1996 ICH Guidance for Industry Q2B Validation of Analytical Procedures: Methodology Additional copies are available from:

More information

ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING

ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING For More Information on Submission of an ANDA in Electronic Common Technical Document (ectd) Format

More information

Library Guide: Pharmaceutical GMPs

Library Guide: Pharmaceutical GMPs Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA

More information

WHO GUIDELINE ON TRANSFER OF TECHNOLOGY

WHO GUIDELINE ON TRANSFER OF TECHNOLOGY September 2009 RESTRICTED WHO GUIDELINE ON TRANSFER OF TECHNOLOGY DRAFT DOCUMENT FOR COMMENT The need for new WHO guidance for transfer of technology was discussed at the fortysecond meeting of the WHO

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) European Medicines Agency Inspections London, 19 May 2005 CPMP/QWP/4359/03 EMEA/CVMP/205/04 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)

More information

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER DISCUSSION IN THE HMPWG 2003-2005 RELEASE FOR CONSULTATION December 2005 DEADLINE

More information

What is Process Validation?

What is Process Validation? What is Process Validation? Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process

More information

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

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 November 2008 (rev.) EudraLex The Rules Governing Medicinal Products in the European Union Volume

More information

Validation and Calibration. Definitions and Terminology

Validation and Calibration. Definitions and Terminology Validation and Calibration Definitions and Terminology ACCEPTANCE CRITERIA: The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an

More information

Top 10 considerations when validating an autoclave

Top 10 considerations when validating an autoclave Top 10 considerations when validating an autoclave Validating an autoclave is a daunting and time-consuming task. This white paper details the tricks, tips and traps to such a validation project from how

More information

MEDICINES CONTROL COUNCIL

MEDICINES CONTROL COUNCIL MEDICINES CONTROL COUNCIL Site Master File GUIDELINES FOR PREPARATION OF SITE MASTER FILE This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master

More information

Hazard Analysis and Critical Control Points (HACCP) 1 Overview

Hazard Analysis and Critical Control Points (HACCP) 1 Overview Manufacturing Technology Committee Risk Management Working Group Risk Management Training Guides Hazard Analysis and Critical Control Points (HACCP) 1 Overview Hazard Analysis and Critical Control Point

More information

Terminal Sterilization. vs. Aseptic Processing

Terminal Sterilization. vs. Aseptic Processing Terminal Sterilization vs. Aseptic Processing Praphon Angtrakool Food and Drug Administration 1 Sterile Drug Products Produced by Aseptic Processing It is a well-accepted principle that sterile drugs should

More information

Implementing New USP Chapters for Analytical Method Validation

Implementing New USP Chapters for Analytical Method Validation Implementing New USP Chapters for Analytical Method Validation March 2010 Ludwig Huber Fax.: +49 7243 602 501 E-mail: Ludwig_Huber@labcompliance.com Today s Agenda Handling Method Changes vs. Adjustments

More information

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation Quality Assurance Disclosure for Lilli Møller Andersen No relevant financial relationships exist for any issue mentioned in this presentation Agenda Quality Assurance Quality Management System Quality

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

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories

More information

Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA

Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs

More information

Corden Pharma Latina S.p.A. 5/20/16

Corden Pharma Latina S.p.A. 5/20/16 Corden Pharma Latina S.p.A. 5/20/16 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 Via UPS Warning Letter 320-16-14 Return Receipt Requested

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

ENVIRONMENTAL MONITORING

ENVIRONMENTAL MONITORING ENVIRONMENTAL MONITORING Assessment and verification of the adequacy of the aseptic compounding environment is essential. Environmental monitoring programs are designed to promptly identify potential sources

More information

FDA Guidance for Industry Update - Process Validation

FDA Guidance for Industry Update - Process Validation FDA Guidance Update: Process Validation: General Principles and Practices White Paper FDA Guidance for Industry Update - Process Validation The changing face of Validation; are IQ, OQ and PQ really dead

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

FILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS

FILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS FILTRATION SOLUTIONS Pharmaceutical Manufacturing filtration specialists Delivering quality filtration products As one of Europe s leading manufacturers of process filters, Amazon Filters is able to offer

More information

Guideline on dossier requirements for Type IA and IB notifications

Guideline on dossier requirements for Type IA and IB notifications Guideline on dossier requirements for Type IA and IB notifications In accordance with Regulation (EC) No 726/2004 and Directives 2001/83/EC and 2001/82/EC, a common approach to the procedures for variations

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

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

GEA Niro Pharmaceutical GMP Spray Drying facility. Spray drying process development and contract manufacturing. engineering for a better world

GEA Niro Pharmaceutical GMP Spray Drying facility. Spray drying process development and contract manufacturing. engineering for a better world GEA Niro Pharmaceutical GMP Spray Drying facility Spray drying process development and contract manufacturing engineering for a better world GEA Process Engineering 2 GEA Niro PSD-4 Chamber cone in clean

More information

The FDA recently announced a significant

The FDA recently announced a significant This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction

More information

PROCESS VALIDATION OF TABLETS: AN OVERVIEW

PROCESS VALIDATION OF TABLETS: AN OVERVIEW PROCESS VALIDATION OF TABLETS: AN OVERVIEW Vikas Verma 1*, Ujjwal Nautiyal 1, M. Senthil Kumar 1, Chandra Kant 1 1 Department of Pharmacy, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India. ABSTRACT

More information

Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing

Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing 1. Introduction 2. Scope 3. Glossary 4. Organization

More information

Liquids Suspensions Gels

Liquids Suspensions Gels Liquids Suspensions Gels EMCM: your product development and manufacturing partner Centre of excellence European Medical Contract Manufacturing (EMCM) is the centre of excellence in developing and manufacturing

More information

P.O.N. RICERCA E COMPETITIVITA' 2007-2013 - Azione II "Interventi di sostegno alla ricerca industriale"

P.O.N. RICERCA E COMPETITIVITA' 2007-2013 - Azione II Interventi di sostegno alla ricerca industriale P.O.N. Ricerca & Competitività 2007-2013 per le Regioni della convergenza Codice Progetto PON01_02464 cofinanziato a valere sull Asse I - Sostegno ai mutamenti strutturali; Obiettivo operativo 4.1.1.1

More information

Process Validation Protocol (Reference: SOP )

Process Validation Protocol (Reference: SOP ) Project Name Equipment Manufacturer Process Line/Location Project Number Serial Number Model Number Protocol number [Enter Product Title, Number & Strength] MULTI VITAMIN TABLETS PRODUCT CODE: Name: Position:

More information

Comparison of EU GMP guidelines with WHO guidelines Identification of the cost-intensive requirements

Comparison of EU GMP guidelines with WHO guidelines Identification of the cost-intensive requirements Comparison of EU GMP guidelines with WHO guidelines Identification of the cost-intensive requirements Dr. Dirk Feldmann Prof. Dr. Hans-Jörg Müller Aim of the study I.) Comparison of the EU and WHO GMP

More information

Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle

Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle Process Performance Qualification Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle A LIFECYCLE Approach to Process Validation? Lifecycle [ICH Q8(R2)]: All phases

More information

GUIDELINES FOR THE VALIDATION OF ANALYTICAL METHODS FOR ACTIVE CONSTITUENT, AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS.

GUIDELINES FOR THE VALIDATION OF ANALYTICAL METHODS FOR ACTIVE CONSTITUENT, AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS. GUIDELINES FOR THE VALIDATION OF ANALYTICAL METHODS FOR ACTIVE CONSTITUENT, AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS October 2004 APVMA PO Box E240 KINGSTON 2604 AUSTRALIA http://www.apvma.gov.au

More information

How Tight is a Syringe? PDA: A Global. CCI Case Studies From. Association. Development and Manufacturing. Dr. Derek Duncan Director Product Line

How Tight is a Syringe? PDA: A Global. CCI Case Studies From. Association. Development and Manufacturing. Dr. Derek Duncan Director Product Line How Tight is a Syringe? PDA: A Global CCI Case Studies From Association Development and Manufacturing Dr. Derek Duncan Director Product Line Presentation Outline Setting up syringe CCI studies using laser-based

More information

PRODUCT DEVELOPMENT GUIDE

PRODUCT DEVELOPMENT GUIDE PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. The order of performing

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

IMPURITIES IN NEW DRUG PRODUCTS

IMPURITIES IN NEW DRUG PRODUCTS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current

More information

STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS

STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS RESTRICTED STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS Discussions are currently ongoing with the WHO Eastern Mediterranean Region towards a synergistic approach in developing a

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center

More information

Combination Products. Presented by: Karen S. Ginsbury For: IFF March 2014. PCI Pharma

Combination Products. Presented by: Karen S. Ginsbury For: IFF March 2014. PCI Pharma Combination Products Presented by: Karen S. Ginsbury For: IFF March 2014 Types of products Biological and medical device (freeze dried + syringe dual volume) Medical device and plasma devised product (syringe)

More information

ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION

ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION TABLE OF CONTENTS 1. INTRODUCTION... 2 2. SCOPE... 2 3. DATA SUBMISSION REQUIREMENTS... 2 4. CONTENT OF DEVELOPMENT

More information

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Kevin O Donnell PhD Market Compliance Manager, IMB PDA / FDA Conference Pharmaceutical

More information