Conducting a Gap Analysis on your Change Control System. Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc.

Size: px
Start display at page:

Download "Conducting a Gap Analysis on your Change Control System. Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc."

Transcription

1 Conducting a Gap Analysis on your Change Control System Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc.

2 Standards, Regulations, Guidelines related to Change Control Management Systems 21 CFR CFR 820 FDA Guideline ICH Q7 GMPs for APIs FDA Guidelines on Pharma. Development (ICH Q8) and PAT FDA Guideline - Quality Risk Management (ICH Q9) FDA Guideline QS Approach to Drug GMPs 2

3 21 CFR 211 Change Control References 21 CFR 211 FDA considers that the requirement for Change Control is implied across the regulations: Archiving of obsolete procedures is necessary Every function and operation requiring documentation should function under a formal change control procedure 21 CFR : Procedures, including any changes, are drafted and approved by the organizational units and reviewed and approved by the quality control unit 21 CFR : Scientifically sound specifications, standards, sampling plans, test procedures and other laboratory control procedures and any changes should be drafted by the appropriate organization and approved by Q.C. 21 CFR (e) Annual review to determine whether changes in specification or manufacturing procedures are needed 3

4 Change Control Statutory and GMP References: Section 506A(b) FD&C Act, Manufacturing Changes, post marketing report requires validation of the effects of a change on the identity, strength, quality, purity and potency FDA Compliance Program Guidance Manual : Post Approval Audit Inspection: A centralized approach could also be used for auditing records of the QC Unit s s change control operations. For those changes identified for products of inspectional interest, the records and supplements related to the changes would be audited for compliance with the requirements 4

5 21 CFR 820 QSR (Device GMPs) Requirements for Change Control Design Changes - Establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation Document Changes: Changes to documents shall be reviewed and approved by individuals in the same function or organization that performed the original review and approval, unless otherwise specified. Approved changes shall be communicated to appropriate personnel in a timely manner. Maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signatures of the approving individuals, the approval date, and the date the change becomes effective. 5

6 21 CFR 820 QSR (Device GMPs) Requirements for Change Control Production and Process Controls: Establish and maintain procedures for changes to a specification, method, process, or procedure. Changes shall be verified or validated before implementation and the activities shall be documented. Changes shall be approved in accordance with document control requirements. Process Validation: When changes or process deviations occur, the process shall be reviewed and evaluated. Revalidation should be performed where appropriate. These activities shall be documented. 6

7 ICH Q7 for API s a formal change control system should be established to evaluate all changes that may affect the production and control of the intermediate or API the potential impact of the proposed change on the quality of the intermediate should be evaluated. A classification procedure may help in determining the level of testing, validation and documentation needed to justify changes to a validated process. Changes may be classified (e.g. minor or major) depending on the nature and extent of changes, and the effects these changes may impart on the process 7

8 ICH Q8 Guideline on Pharmaceutical Development The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space*, specifications, and manufacturing controls. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space. 8

9 Q8 Concept on Design Space The design space is the established range of process parameters that has been demonstrated to provide assurance of quality. In some cases design space can also be applicable to formulation attributes. Working within the design space is not generally considered as a change of the approved ranges for process parameters and formulation attributes. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. 9

10 FDA on Design Space The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality Traditional one dimensional process range doesn t meet Q8 definition and will not lead to regulatory flexibility Working within the design space is not considered as a change Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process Design space is proposed by the applicant and is subject to regulatory assessment and approval 10

11 Quality Risk Management (ICH-Q9) relation to Change Control Use Risk analysis to determine requirements after change implementation Use Impact (Direct, Indirect) concepts to determine impact and requirements/tests Make that evaluation part of the Change Control procedure and documentation rationale for decision Evaluation that changes did not create new hazards 11

12 Quality Systems Approach to Pharmaceutical GMP s Guidance from FDA (Sept. 2006) Implementation of Quality Systems, when coupled with manufacturing process and product knowledge, can handle changes without a need for regulatory submissions - changes in facility, equipment or even processes Quality by Design Concept Application of risk analysis Change Control must be controlled and documented: managing change to prevent unintended consequences Warranted when data analysis reveals areas for improvement Effect evaluated after implementation According to CGMP regulations, the QCU has the responsibility of reviewing and approving all initial design criteria and procedures pertaining to facilities and equipment and any subsequent changes (see (c)) If design issues are found during process experience, the entire design (facility/equipment/process/laboratory controls) has to be evaluated 12

13 Personnel Training under the Quality Systems Personnel should also understand the effect of their activities on the product and the customer. Quality personnel should be selected based on their scientific and technical understanding, product knowledge, process knowledge and/or risk assessment abilities to appropriately execute certain quality functions Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior). 13

14 Quality Systems - Elements Management Responsibilities: Commitment Structure roles and responsibilities Environment Communication Formal process for change requests Continuous Improvement Resources: Training/Qualifications Manufacturing Operations changes to improve controls over sources of variability a manufacturer is empowered to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product s lifecycle. Evaluation Activities (Management): Change Control Management Effectiveness Revise procedures as needed Resulting action plans may involve changes 14

15 ICH Q10 QS Elements Knowledge Management and Risk Management as Enablers of QS change management will be dependent on the knowledge management and adequate process/product knowledge Quality Manual Policy, Scope, Structure of QS and Management Responsibilities Management Responsibility as Ultimate Responsible for QS Commitment, Quality Policy, Planning, Resources, Communication and Review Continual Improvement of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review Continual Improvement of the Pharmaceutical Quality System 15

16 What is Change Control? Change Control is the implementation of, and adherence to, a formal process that documents any change to a (specified/qualified/validated/approved) piece of equipment, system, process or document that can affect the identity, strength, quality or purity of a drug product. 16

17 Why is Change Control Important? COMMON SENSE Change Control is a key component of the Quality System of an organization (systems based approach to FDA inspections and QS Guideline) managing change to prevent unintended consequences Encouraging change towards continual improvement Need to evaluate effect of changes starting at the specifications level for the Direct and Indirect Impact Systems Changes must be documented for future reference even during Design and earlier Qualification stages 17

18 When Should Change Control Be Implemented? Need a policy for Change Control Management which will include applications at different points Define application for new and/or modifications to facilities, utilities, equipment and systems Formal QA Change Control procedures MUST be implemented upon completion of the Qualification / Validation Implement change control for all Direct and Indirect Impact systems level of detail/depth of impact determination will be commensurate with the impact level of the system/process Once the system / equipment is identified and specified (approved documents), it falls under some level of change control 18

19 Change Control Levels early in Projects Impact Determinations and Application of Risk Direct Impact Systems more documentation required and a formal risk assessment done for changes Indirect Impact Systems basic procedure and form to be completed. No need for formal risk assessment as part of the change impact analysis. Responsibilities must be defined for each project phase User functions to be involved Quality (at a defined level) 19

20 Change Control Policy/Procedure Requirements with respect to Specifications, Design, Construction, Commissioning and Qualification Purpose/Objective Scope Responsibilities Procedure: Describe Change and Impact Approval Implementation Verification Forms for each stage in the process or a generic form Summary Report at project completion including changes to specifications 20

21 Applications of a formal QA Change Control System Documents SOPs, Qualification/Validation documents, batch production records, regulatory filings Facilities Utilities, systems (WFI, HVAC, etc.), environmental conditions Equipment Control systems, mechanical systems, computer systems (software), instrument calibration, maintenance Processes Cleaning (not SOPs changes in products/formulas), analytical methods, manufacturing, packaging 21

22 Developing a formal QA Change Control SOP SOPs Should Be: Clear Concise Designed to prevent problems Sufficiently detailed to ensure everyone performs his/her part in a reasonably consistent manner Different SOPs for types of changes documents versus equipment/systems? 22

23 Developing a formal QA Change Control SOP Components Responsibilities How initiated? Who reviews? Who approves? Who trains? Who owns? 23

24 Developing a formal QA Change Control SOP Components (cont.) What is a change? Like for Like Definition is it applied consistently? Planned vs. Unplanned Normal vs. Emergency Temporary Changes careful! How to complete forms? Information to be recorded 24

25 Developing a formal QA Change Control SOP Components (cont.) How to track changes? Unique identifier Track from start to finish Constant monitoring of open changes Filing / archiving system 25

26 Developing a formal QA Change Control SOP Components (cont.) How to define system? Required information How to document change? Detailed description of change Level and degree of testing required Identify any special procedures that need to be followed during change implementation 26

27 Developing a formal QA Change Control SOP Components (cont.) Is there additional impact? Documentation Equipment Systems What is the closure mechanism? Qualification/Validation summary report Final approval of change control form 27

28 Developing a formal QA Change Control SOP Components (cont.) What is the appropriate notification system? Timely and appropriate Change implementation successful Final approvals / Release for production Required QA/QC pre- and post-approval Impact assessment 28

29 Developing a formal QA Change Control SOP Less is Better One corporate policy vs. one for each site/department May need specific site procedures for each type of change Assures consistency Document control is less burdensome Present a clear message of upper management commitment 29

30 Normal Situations Initiate Change Control Form Document equip/system affected Identify needed change Sign/date form Route proposed change for review and approval 30

31 Normal Situations (cont.) Determine whether change requires revalidation Substantiated like for like changes may not require revalidation Once approved, implement change Test changed system as required 31

32 Normal Situations (cont.) Generate final report Change control form Qualification/Validation summary report Route for final approval Archive change control documentation 32

33 Emergency Situations Preparation Prevents Problems Follow guidelines established in SOP Fill in as much information as possible Identify problem / change required sign/date form Notify as many approvers as possible Gain verbal approval Continue with Change / testing Document all steps QUARANTINE system 33

34 Emergency Situations Emergency changes must be closed appropriately Within specified time limit provided by procedure Provide Identifier Formal routing procedure Continued tracking Proper approval, closure and notification through appropriate channels 34

35 Implement the Program Have Qualification / Validation baseline in place Provide comprehensive training - level of comprehension assessment detail will be commensurate with level of control Provide Effective Date for SOPs 35

36 How to Determine the level of competency assessment required for training on change control? Based on Product Quality Impact and other risk considerations: Is the operation/process affected by change purely manual? Are there detection capabilities to verify effectiveness of process/procedure execution? Who Reviews/Approves the change before implementation? Is there a physical barrier or control impeding change implementation? Need to include the decisions on formal training plans 36

37 Changes in Documentation Categorization of SOPs different levels of changes Operational SOPs critical versus non-critical steps/operations Maintenance critical pieces of equipment/systems Cleaning Manual versus automated Quality Functions basic responsibilities Specifications: Critical quality Attributes Raw materials/components critical impact on process 37

38 Changes in Process Batch Manufacturing Controls commensurate with criticality parameters and steps Design space in or out Regulatory submittal 38

39 Change Control - Equipment Weaker system level of control is personnel dependent Adequate and Effective training and fullcommitment are keys to the program Pre and post approval of changes by pertinent functions Apply process appropriately for each type of change definitions are critical Impact of Change determined adequate personnel to evaluate Documentation of results and modified documents and drawings included in package Quality review Change does not require requalification - evaluation of change impact will determine need for it or any additional validation test 39

40 Definitions How to Verify their Application Like for Like versus Change: Verify Work Orders for replacements, repairs Definitions clear in procedure interview related personnel to verify interpretation Planned versus Un-Planned Changes: Verify forms for compliance with procedure approvals by pertinent functions, timing, completion Training evaluation if previous areas show gaps 40

41 Changes on Software Upgrades or Updates Specific (per system or control type) procedure to handle those changes Procedure/Forms to address frequent types of changes in consistent manner 41

42 Maintaining the Program Provide reinforcement training to address deficiencies in the correct use of the change control system Provide separate Procedures for the conduct of annual review of all system changes to determine if the system should be subjected to a full or modified revalidation 42

43 Maintaining the Program (cont.) Annual QA/QC Review Production Problems / Failures Process Changes Assess impact on product quality Identify otherwise undetected changes Determine when revalidation is necessary When changes affecting the process are not controlled, the process may no longer be truly valid 43

44 Gap Analysis Process

45 Gap Analysis Definition The assessment of differences or discrepancies between a set of standards (regulations/guidelines) and the current procedures in place to determine the criticality of such and the actions required for remediation (Risk Based decisions) Evaluation of a specific program or process to determine how it compares to a pre-defined set of objectives, goals, or standards. Defining the specific objectives or expectations to be met is the most difficult part of the GAP Analysis. Required or Recommended? Gap Analysis is usually conducted in order to determine the steps needed to bring a system into compliance with the applicable regulations/guidelines/policies 45

46 Then, What is it? The GAP Analysis is simply a comparison of the current system, its supporting documentation, and the people/resources qualifications/training against the defined requirements.

47 Gap Analysis Process Identify standards (Quality Systems Guides/Regs. Or internal policies) and familiarize with requirements: Change Control Management Policy/Procedures Provide training on conducting a Gap Analysis and the specific requirements to be verified define responsibilities Assess current practices against standards Identify needs for remediation plans (immediate and long term action plans) based on criticality/risk Implement remediation plans 47

48 Gap Analysis Team Gap Analysis Team Selection qualified members and lead person Develop Checklist provide reference material to team members (regulatory and industry standards, local policies and procedures) Discuss adequate Documentation - record what was reviewed, what was seen, who was talked to, observations made, etc Discuss procedure for documentation of observations/gaps, handling of response and communication of results to management Define priorities and criticality levels for gaps 48

49 Gap Analysis Process General Things to Assess for each defined Requirement Do the Procedures, Policies, Forms and Templates for the system/program meet the defined requirements per the standard? (establish) Have the requirements been met in actual practices? Documentation shows that the procedure is being executed as written (implement) Do employees understand the program, expectations, etc? Are they trained? Are resources necessary to support the program appropriate (support) 49

50 How to Conduct the Gap Analysis Conduct an opening meeting with areas to be verified/assessed and the gap analysis team Discuss the process, times, deliverables List the areas, processes to be assessed based on the selected priorities Discuss and document the categorization strategy for the observations and remediation plans Ensure people will be available when needed Ensure that documentation will be available Conduct a Wrap-Up meeting at the end of the audit 50

51 GAP Analysis DOs and DON TS The gap analyst: Do prepare. Know the objectives and scope Do be objective, but thorough Do get opinions and ideas from the employees in the area effected Don't go beyond the scope Don't be judgmental Don't focus on listing errors or defects, but determine why the errors or defects occurred Employees in the area being analyzed: Do communicate problems or quality issues that you know about to the analyst, so they can be recorded and corrected Do provide open and honest answers Do share ideas for improvements Don't be defensive Don't place blame 51

52 Focus of review Change Control Procedures: Adequate Compliant Effective Personnel is committed to perform as described Reviewed/Updated Training: Effective Comprehension Assessment Tool Properly documented Execution: Adequate Documentation Handling of Deviations/Exceptions Required Reviews/Approvals 52

53 Classification of Observations gathered during the assessment Critical: The procedure or program is considered inadequate lacks basic elements or requirements The gap could place the product quality on risk of being nonconforming Major: The procedure needs revisions to make it compliant but the gap will not have a significant effect on product quality or the effectiveness of the overall system Minor: Documentation has to be corrected Procedure must be modified without a critical effect on the systems/process or product quality 53

54 Example Outcomes Typical Observations: Lack of Standards, Processes, Procedures or those are not applied at all Failure to comply with Standards, Regulations, guidance documents, Processes, Procedures not being executed as written Shortfalls in documentation and records Lack or inadequate reviews/impact assessment/approvals Procedures state one way, but documentation reflects a different action Lack of or inadequate definitions of roles and responsibilities Definitions are not used consistently changes versus like-for-like, etc. 54

55 Typical Areas of Concern - Outsourcing Suppliers changes in their process/materials Contract Manufacturers change control management within their operation and communication to process owner (Contract giver) Contract Services providers: Laboratories Calibrations Keys to control: Agreements key contacts/responsibilities Internal Quality System/Function and Adequate Procedures Responsiveness Communication and Trust Planning Audits Filing (if applicable) 55

56 Gap Analysis Assessment Report, Remediation Plan and Follow-up The Gap Analysis team leader shall issue a report within a reasonable time after completion of the assessment The report should describe the findings in sufficient detail to assure corrective action can be accomplished by the organization The responsible manager investigates the cause of the problem noted as a noncompliance and proposes a remediation action to be taken (plan) Indicates the date by which the remediation will be fully implemented The team leader reviews and approves the proposed action Report the effectiveness of the program to management Re-audit areas of concern or deficiencies. 56

57 Remediation Plans Critical gaps versus action plans for longer term resolutions SOP non-conformances revise as needed to comply with the standards Revise Documentation to reflect what the SOP requires Training adequate implementation of the revisions and changes due to the remediation actions 57

58 Conclusions Change Control Management will be a critical enabler of the new Quality Systems approach to GMPs as the FDA expects the industry to manage changes internally with the application of your process/product knowledge and the objective to continuously improve your processes Procedure, Training and Documentation are the key to an effective Change Control Management System Apply a risk factor after the gap analysis/assessment to determine the need for immediate resolutions versus a long term remediation plan 58

59 Questions? 59

60 Interactive Exercise Develop Gap Analysis Checklists for: SOP Change Control System Facility/Utilities/Equipment Change Control System Manufacturing Batch Record Change Control System 60

61 THANK YOU!!! Contact Info.: Miguel Montalvo Expert Validation Consulting, Inc. Mobile Phone +1(407)

Change Control. A Key Element of a Quality System

Change Control. A Key Element of a Quality System IVT 9 th Annual Conference Change Control Change Control A Key Element of a Quality System Jerry Lanese Ph.D. CMC The Lanese Group, Inc. 2011 The Lanese Group 1 Will discuss A Quality System What is it

More information

COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS

COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance

More information

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing

More information

GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme

GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme Contents 1. Why good documentation is essential? 2. What constitutes

More information

LIBRARY GUIDE: Pharmaceutical GMPs

LIBRARY GUIDE: Pharmaceutical GMPs LIBRARY GUIDE: Pharmaceutical GMPs Table of Contents Overview............................................................................ 3 Courses Listed by Functional Area....................................................

More information

Corrective and Preventive Actions

Corrective and Preventive Actions Corrective and Preventive Actions A Five Step Approach Topics to Be Covered What is CAPA? Governing authority Five steps to a good CAPA process Where companies have difficulty Example citations Recap What

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

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE STANDARD OPERATING PROCEDURE Title: Discrepancy Report Procedure Effective Date: Approvals (Signature and Date): Responsible Department Head Technical Authority QA/QC 1. PURPOSE 1.1 To describe a method

More information

Quality Program, CAPA and Audits

Quality Program, CAPA and Audits Quality Program, CAPA and Audits 3 rd Annual FDA and the Changing Paradigm for HCT/P Regulation January 25, 2007 Mary Malarkey, Director, OCBQ, CBER Summary CGTP CGMP QS Regulation Quality comparison CAPA

More information

Change Management in Development White Paper

Change Management in Development White Paper Change Management in Development White Paper Introduction/Background In 2008, the International Conference on Harmonization published the ICH tripartite guideline titled, Pharmaceutical Quality System:

More information

Although not specifically

Although not specifically Change Control: Seven Pharmaceutical Manufacturers Share Their Experiences Individuals from seven different pharmaceutical companies met to discuss change in the pharmaceutical industry, what a change

More information

Harmonizing Change Control Processes Globally

Harmonizing Change Control Processes Globally Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses

More information

TGA Sciences Quality Assurance Documentation System

TGA Sciences Quality Assurance Documentation System March 26, 2013 March 22, 2007 n/a 1 of 5 1.0 PURPOSE AND INTRODUCTION 1.1 To provide a system with intent of continuous improvement that shall capture issues in order to eliminate potential causes for

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

PHARMACEUTICAL QUALITY SYSTEM Q10 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step

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

ORACLE CONSULTING GROUP

ORACLE CONSULTING GROUP ORACLE CONSULTING GROUP 9 Golder Ranch Rd., Ste. 1 Tucson, Arizona 9 Web Site: E-mail: 20-2-0 20-2-0 (FAX) CONSULTING MEMORANDUM QUALITY SYSTEM INSPECTION TECHNIQUE

More information

Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants

Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Alex D. Kanarek, PhD BioProcess Technology Consultants, Inc. Strategic Institute Quality

More information

Edwin Lindsay Principal Consultant. Compliance Solutions (Life Sciences) Ltd, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co.

Edwin Lindsay Principal Consultant. Compliance Solutions (Life Sciences) Ltd, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co. Edwin Lindsay Principal Consultant, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co.uk Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

GxP Process Management Software. White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations

GxP Process Management Software. White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations GxP Process Management Software : Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations Most FDA violations involve one of the following: Not having procedures in a regulated area

More information

Best Practice In A Change Management System

Best Practice In A Change Management System Quality & Compliance Associates, LLC Best Practice In A Change Management System President Quality & Compliance Associates, LLC Change Control and Its Role in a Continuous Improvement Environment 3 Benefits

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

Author General Management Quality Assurance

Author General Management Quality Assurance Lab Ofichem B.V. Pag.: 1 / 14 Date: 20-01- Version: 02 Status: geldig Contents 1. General... 2 2. Shared Third Party audit program... 3 3. Reassurance absence of Conflict of Interest... 5 4. Contract structure...

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

Preamble to GMP Kefauver-Harris Amendments

Preamble to GMP Kefauver-Harris Amendments CGMP for Phase 1 Clinical Trials Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Academic Health Center Director, IND/IDE Assistance Program Lead, Regulatory Knowledge and Support Clinical

More information

Synopsis: FDA Process Validation Guidance

Synopsis: FDA Process Validation Guidance Synopsis: FDA Process Validation Guidance This synopsis is a comparison of the draft version 2008 and the final version 2011 of the U.S. FDA Guidance Process Validation: General Principles and Practices.

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4) U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics

More information

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps)

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Anita R. Michael, Pharmaceutical Specialist FDA Office of Regulatory Affairs 1 Process Validation

More information

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address: NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a

More information

CAPA Overview Training

CAPA Overview Training CAPA Overview Training Ground Rules Please put your cell phones on vibrate. Actively participate and ask questions freely. This will help you learn. You must be in attendance for the entire training session

More information

Organization of QA cgmp compliance. BIT 230 Chapters 1 and 2 (Huxsoll)

Organization of QA cgmp compliance. BIT 230 Chapters 1 and 2 (Huxsoll) Organization of QA cgmp compliance BIT 230 Chapters 1 and 2 (Huxsoll) TQM Total Quality Management Approach a company uses day to day 7 strategies Leadership Information and analysis Strategic planning

More information

Functional Production, QC, Validation, Engineering, NPD, Warehouse, IT, Logistics, and Training Personnel.

Functional Production, QC, Validation, Engineering, NPD, Warehouse, IT, Logistics, and Training Personnel. JOB DESCRIPTION JOB TITLE: QUALITY ASSURANCE OFFICER JOB TEAM: QUALITY ASSURANCE REPORTS TO: QUALITY ASSURANCE TEAM LEADER DATE UPDATED: MARCH 2011 Specification Purpose: Responsible for the review of

More information

IVD Regulation Overview. Requirements to Assure Quality & Effectiveness

IVD Regulation Overview. Requirements to Assure Quality & Effectiveness IVD Regulation Overview Requirements to Assure Quality & Effectiveness CLIAC Jan. 2002 Statutory and Regulatory Requirements Statute: Food, Drug, and Cosmetic Act Food and Drugs Act of 1906 Food and Drug

More information

Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities

Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities September 2, 2003 Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities Purpose This document provides a summary of the requirements relating to use of computer-based systems in activities

More information

The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.

The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations

More information

ICH guideline Q10 on pharmaceutical quality system

ICH guideline Q10 on pharmaceutical quality system September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final

More information

Guidance for Industry: Starting Material Supplier Management

Guidance for Industry: Starting Material Supplier Management Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and

More information

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 CDER Office of Regulatory Policy Jane Axelrad, JD CDER Office of Compliance Brenda Uratani, Ph.D. CDER ONDQA Ravindra Kasliwal, Ph.D.

More information

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Global Pharma Sourcing Conference December 6-7, 2011 Philadelphia, USA Nigel J. Smart, Ph.D. Smart Consulting

More information

Pharmaceutical Quality Systems: US Perspective

Pharmaceutical Quality Systems: US Perspective Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical

More information

On-Site GMP Training GMP COMPLIANCE TECHNICAL

On-Site GMP Training GMP COMPLIANCE TECHNICAL PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program

More information

LIBRARY GUIDE. Online Courses. March 2012

LIBRARY GUIDE. Online Courses. March 2012 LIBRARY GUIDE Online Courses March 2012 i Table of Contents OVERVIEW..................................................................................... 1 COURSE DESCRIPTIONS (LISTED ALPHABETICALLY)...............................................

More information

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP)

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) Nutrition Supplier Meeting, June 30, 2015 Dimitris Catsoulacos Quality Assurance Specialist PRESENTATION OVERVIEW Quality

More information

Deviation Management: From Discovery to Reporting

Deviation Management: From Discovery to Reporting Deviation Management: From Discovery to Reporting The Practical Side of What to Do Nancy H. Collins, PhD. The University of Toledo Medical Center Dept. of Medical Microbiology & Immunology What are Deviations?

More information

Process Validation: Practical Aspects of the New FDA Guidance

Process Validation: Practical Aspects of the New FDA Guidance Process Validation: Practical Aspects of the New FDA Guidance ISPE Boston Chapter Meeting April 18, 2013 Rusty Morrison Commissioning Agents, Inc. Objectives / Summary What is Process Validation? Regulatory

More information

Quality Assurance Inspections. original signed

Quality Assurance Inspections. original signed Title Quality Assurance Inspections SOP Code 901.002 Effective Date 01-July-2016 Site Approvals Name and Title (typed or printed) Karine Morin Executive Director, Platforms Signature original signed Date

More information

Risk-based Supplier Qualification

Risk-based Supplier Qualification FDA on Supplier Control Determined by Product Risk (Silver Sheet, May 2007) Control should be based on the risk associated with the device How have you related this to the work you did in your design and

More information

I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control.

I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control. SOP Number: SOP -001 Page 1 of 5 4/18/2013 Effective I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control. II. SCOPE All SOP s

More information

QA Procedure Page 1 Appendix A

QA Procedure Page 1 Appendix A *Changes from the previous QASE noted by "yellow" highlight of block Evaluation Summary Company: Prepared By: Section Element Manual Audit OK Objective Evidence 2.1 Objective of Quality Assurance Program

More information

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 Quality Management System - integrating GMP (ICH

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

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

Quality Manual. DuraTech Industries, Inc. 3216 Commerce Street La Crosse, WI 54603 MANUAL SERIAL NUMBER 1

Quality Manual. DuraTech Industries, Inc. 3216 Commerce Street La Crosse, WI 54603 MANUAL SERIAL NUMBER 1 Quality Manual Approval Page Document: QA1000 Issue Date: 5/29/1997 Page 1 of 17 Revision Date: 5/20/2013 DuraTech Industries, Inc. 3216 Commerce Street La Crosse, WI 54603 MANUAL SERIAL NUMBER 1 This

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

ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR

ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR Page 1 of 20 ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR SUPPLIER/ SUBCONTRACTOR NAME: ADDRESS: CITY AND STATE: ZIP CODE: SUPPLIER/MANUFACTURER NO PHONE: DIVISION:

More information

ICH Q10 Pharmaceutical Quality System (PQS)

ICH Q10 Pharmaceutical Quality System (PQS) ICH Q10 Pharmaceutical Quality System (PQS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Q10 PQS Guideline Background Objectives

More information

Quality Manual # QS001.3. MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality

Quality Manual # QS001.3. MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality # QS001.3 MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality Date Review indicates that qualified persons from operational areas have reviewed the content

More information

OPERATIONAL STANDARD

OPERATIONAL STANDARD 1 of 11 1. Introduction The International Safe Transit Association (ISTA), a non-profit association whose objective is to prevent product damage and excess packaging usage within the distribution environment.

More information

NSF Dietary Supplement

NSF Dietary Supplement NSF Dietary Supplement SOP Template Book A guide to achieving and maintaining compliance to 21 CFR 111: Dietary Supplement Good Manufacturing Practices 2 Contents How to Use...4 About NSF Dietary Supplements...5

More information

Auditing as a Component of a Pharmaceutical Quality System

Auditing as a Component of a Pharmaceutical Quality System Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a

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

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This

More information

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution QC Micro Webinar Series Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution Rapid Testing Solutions / Lonza / 07 Jun 2011 Today s Presenters Bob Toal Segment Manager, Informatics

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

Pharmaceutical Quality System Bringing cgmp into the 21 st Century. Granite State 15 March 2012 Theresa McCarthy

Pharmaceutical Quality System Bringing cgmp into the 21 st Century. Granite State 15 March 2012 Theresa McCarthy Pharmaceutical Quality System Bringing cgmp into the 21 st Century Granite State 15 March 2012 Theresa McCarthy Agenda International Conference on Harmonization ICH Q10 Pharmaceutical Quality System Relationship

More information

LIBRARY GUIDE. Online Courses. September 2011

LIBRARY GUIDE. Online Courses. September 2011 LIBRARY GUIDE Online Courses September 2011 i Table of Contents Overview... 1 Course Descriptions (Listed alphabetically)... 2 A Guide to ISO 13485 The Quality Management System for Medical Devices (DEV50)....

More information

Preparing for an FDA Pre-Approval Inspection (PAI)

Preparing for an FDA Pre-Approval Inspection (PAI) Preparing for an FDA Pre-Approval Inspection (PAI) Jorge Torres CMQ/OE, CQE, CQA July, 2007 1 Agenda Introduction Understanding the PAI Experience: What to Expect Inspection Management Plan Preparing for

More information

ISO 13485:201x What is in the new standard?

ISO 13485:201x What is in the new standard? ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed

More information

Implementing ISO 9000 Quality Management System

Implementing ISO 9000 Quality Management System Implementing ISO 9000 Quality Management System Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in 'cultural transition' to

More information

The Future of Process Validation - Going Back to Basics

The Future of Process Validation - Going Back to Basics IVTJVT1107.qxd 10/8/07 3:27 PM Page 36 The Future of Process Validation - Going Back to Basics The New FDA Perspective as a Refocus on the Original Definition of Process Validation BY MIGUEL MONTALVO INTRODUCTION

More information

CORPORATE QUALITY MANUAL

CORPORATE QUALITY MANUAL Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance

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

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

ISO 9001: 2008 Construction Quality Management System Sample - Selected pages (not a complete plan)

ISO 9001: 2008 Construction Quality Management System Sample - Selected pages (not a complete plan) ISO 9001: 2008 Construction Quality Management System Sample - Selected pages (not a complete plan) Part 1: Project-Specific Quality Plan Part 2: Company Quality Manual Part 3: Submittal Forms Part 4:

More information

Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations

Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations This paper discusses the nuances of lifecycle validation implementation at contract manufacturing organizations (CMOs).

More information

QbD WHO. Effective Personnel Qualification Does the Job Description Play a Role in CGMP Compliance? FMEA. Deviations. Verification GHTF.

QbD WHO. Effective Personnel Qualification Does the Job Description Play a Role in CGMP Compliance? FMEA. Deviations. Verification GHTF. Effective Personnel Qualification Does the Job Description Play a Role in CGMP Compliance? Eldon Henson Critical quality attributes API QbR EMEA CALIBRATION Design space Deviations IQ ICH Maintenance Validation

More information

INTERPLANT STANDARD - STEEL INDUSTRY SPECIFICATION & GUIDE FOR CALIBRATION SYSTEM OF INSTRUMENTATION. No Corresponding IS

INTERPLANT STANDARD - STEEL INDUSTRY SPECIFICATION & GUIDE FOR CALIBRATION SYSTEM OF INSTRUMENTATION. No Corresponding IS INTERPLANT STANDARD - STEEL INDUSTRY IPSS SPECIFICATION & GUIDE FOR CALIBRATION SYSTEM OF INSTRUMENTATION No Corresponding IS IPSS: 2-07-098-14 0. FOREWARD 0.1. Interplant standardization: Standardization

More information

Good Manufacturing Practices (GMP) for Pharmaceutical Excipients

Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Not for publication. This draft text is for circulation for approval by the Joint Committee and has not been published or otherwise officially promulgated. All rights reserved. This document may be reproduced

More information

RTP s NUCLEAR QUALITY ASSURANCE PROGRAM

RTP s NUCLEAR QUALITY ASSURANCE PROGRAM RTP s NUCLEAR QUALITY ASSURANCE PROGRAM RTP operates under one quality program, whether you purchase products that are commercial grade, nuclear safety-related or industrial safety compliant (IEC 61508).

More information

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC.

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of

More information

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry PLM technology ensures FDA compliance

More information

Approaching the Response to Audit Observations

Approaching the Response to Audit Observations Introduction Approaching the Response to Audit Observations One of the first things consistently drilled into my collective memory was the statement that we should always be prepared for an audit. It was

More information

1 The quality management system (QMS) is the corner stone of compliance to GMP. The QMS is made up of several documents, that when followed ensures the GMP compliance of the process, facility and company.

More information

Construction Quality Control/Quality Assurance Plan Bozeman Landfill LFG/SVE/AI and Treatment System City of Bozeman Landfill; Bozeman, MT

Construction Quality Control/Quality Assurance Plan Bozeman Landfill LFG/SVE/AI and Treatment System City of Bozeman Landfill; Bozeman, MT Construction Quality Control/Quality Assurance Plan Bozeman Landfill City of Bozeman Landfill; Bozeman, MT #114-560487 July 10, 2015 PRESENTED TO PRESENTED BY City of Bozeman PO Box 1230 Bozeman, MT 59711-1230

More information

Camar Aircraft Products Co. QUALITY MANUAL Revision D

Camar Aircraft Products Co. QUALITY MANUAL Revision D QUALITY MANUAL Revision D Gujll'y Manual Introduction The purpose of this manual is to describe the Quality Assurance Program implemented by Camar Aircraft Products Co. (hereafter referred to as C.A.P.C.)

More information

FLW FLW QUALITY MANUAL APPROVAL SIGNATURES

FLW FLW QUALITY MANUAL APPROVAL SIGNATURES FLW QUALITY MANUAL APPROVAL SIGNATURES Prepared by: Matthew Peek, Quality Manager Date: Approved by: Dale Laube, Service Manager Date: Approved by: Andrew Peek, Sales Manager, President Date: Quality Manual

More information

Audit Report in the framework of the APIC Audit Programme

Audit Report in the framework of the APIC Audit Programme Audit Report in the framework of the APIC Audit Programme Company Location Address Country Subject of Audit Audit Date Auditor (lead) Co-Auditor(s) Participants Signature of Auditor(s) Lead Auditor Co-Auditor

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

We are presented with

We are presented with Be SMART With Your Corrective and Preventative Actions (CAPA) Compliance can only be achieved when the corrective action is in place, and is acting synergistically with all quality systems. by Larry ld

More information

ICH Q10 - Pharmaceutical Quality System

ICH Q10 - Pharmaceutical Quality System WCC PDA Dinner Meeting Jan 2012 ICH Q10 - Pharmaceutical Quality System Neil Wilkinson NSF-DBA www.nsf-dba.com ICHQ10.1 WCC PDA Dinner Meeting Jan 2012 Your Presenter Partner at NSF-DBA USA Training, Consultancy,

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

[Project Name] Project Human-Resource Management Plan. [Sub-Project, phase, etc.] [Company] [Company Address]

[Project Name] Project Human-Resource Management Plan. [Sub-Project, phase, etc.] [Company] [Company Address] [Company] [Company Address] Tel: Fax: [Company Phone] [Company Fax] [Company E-mail] May 16, 2015 [Ref. number] Marc Arnecke, PMP [Project Name] [Sub-Project, phase, etc.] The is a component of the Project

More information

Laboratory Self-Audits

Laboratory Self-Audits P e e r R e v i e w e d : A u d i t 101 Laboratory Self-Audits Paul L. Pluta and Jerry Lanese Audit 101 provides useful and practical information that addresses various topics associated with audits. Common-sense

More information

GMP POPCORN EXERCISE CHECKLIST

GMP POPCORN EXERCISE CHECKLIST GMP POPCORN EXERCISE CHECKLIST Goal: Make a batch of GMP popcorn within a specified timeframe (1.5 hours). Objective: Understand the complexity of a GMP process. Gain appreciation of teamwork and cooperation

More information

ATTACHMENT COMPARISON OF APPENDIX B TO ISO CFR 50 APPENDIX B ISO REGULATORY IMPACT/COMPLIANCE

ATTACHMENT COMPARISON OF APPENDIX B TO ISO CFR 50 APPENDIX B ISO REGULATORY IMPACT/COMPLIANCE ATTACHMENT COMPARISON OF APPENDIX B TO ISO 9001-2000 CRITERION I: ORGANIZATION 10 CFR 50 APPENDIX B ISO 9001-2000 REGULATORY IMPACT/COMPLIANCE I - Responsibility for establishing and executing of a quality

More information

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70 Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initiating

More information

This interpretation of the revised Annex

This interpretation of the revised Annex Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation

More information

Intercompany Protocol for the execution of shared 3 rd Party Suppliers Audits

Intercompany Protocol for the execution of shared 3 rd Party Suppliers Audits for the execution of shared 3 rd Party Suppliers Audits Ref. document: AFA_INTERCOMPANY_PROT_04_01 Revision / Date: Rev.04.01 / May the 30 th 2013 Coming into operation: May the 31 st 2013 Number of pages:

More information