Change Control. A Key Element of a Quality System

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1 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 The Lanese Group 1

2 Will discuss A Quality System What is it Purpose Quality System compared to other management systems Continuous improvement Integrated components of a Quality System 2011 The Lanese Group 2

3 What is a Quality System 2011 The Lanese Group 3

4 2011 The Lanese Group 4

5 2011 The Lanese Group 5

6 2011 The Lanese Group 6

7 2011 The Lanese Group 7

8 Management Review Change Control records Investigations Documents Production Controls Validation 2011 The Lanese Group 8

9 2011 The Lanese Group 9

10 ` 2011 The Lanese Group 10

11 Organizational Profile: Environment, Relationships, and Challenges Strategic Planning Human Resource Focus Leadership Business Results Customer and Market Focus Process Management 2011 The Lanese Group Measurement, Analysis and Knowledge Management 11 Baldrige

12 Baldrige Organizational Profile 1. Leadership 2. Strategic Planning 3. Customer and Market Focus 4. Measurement, Analysis, and Knowledge Management 5. Human Resource Focus 6. Process Management 7. Business Results

13 Continual Improvement of the quality management system Management Responsibility Customers Customers Resource Management Measurement, Analysis and Improvement Requirements Input Product Realization QMS Output Product Satisfaction ISO

14 Management Design Controls Production & Process Controls Material Controls Corrective & Preventive Actions Records, Documents, & Change Controls Equipment & Facility Controls Controls 2011 The Lanese Group 14 FDA QSIT Presentation

15 Medical Device Reporting Reports of Corrections and Removals Medical Device Tracking Facility & Equipment Controls Corrective & Preventive Actions Design Controls MANAGEMENT 2011 The Lanese Group Material Controls Records/ Documents/ Change Controls 15 Production & Process Controls Sterilization Process Controls FDA QSIT Presentation

16 Production System Quality Packaging & Labeling System Facilities & Equipment System System Materials System Laboratory Controls System

17 Purpose of a XXX Quality System To enhance the quality and availability of products around the world in the interest of public health. Facilitate innovation and continual improvement and strengthen the link between development and manufacturing activities The Lanese Group 17

18 What is in the Quality System 2011 The Lanese Group 18

19 Process Performance and Product Quality Monitoring Corrective Action Preventive Action Change Management Management Review of Process Performance and Product Quality Elements that promote the life-cycle approach ICH Q7A Regional EU GMP GMPs 21CFR 210, 21CFR211 Regional GMPs 2011 The Lanese Group 19

20 Process Performance and Product Quality Monitoring Corrective Action Preventive Action Change Management Management Review of Process Performance and Product Quality ICH Q7A EU GMP 21CFR 210, 21CFR211 Regional GMPs 2011 The Lanese Group 20

21 Process Performance and Product Quality Monitoring Corrective Action Preventive Action Change Management Management Review of Process Performance and Product Quality ICH Q7A EU GMP 21CFR 210, 21CFR211 Regional GMPs 2011 The Lanese Group Product Realization ICH Q10 State of Control Objectives Continual Improvement 21

22 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuance Investigational Products GMP Management Responsibilities PQS Elements Process Performance and Product Quality Monitoring System Corrective Action/Preventive Action (CAPA) System Change Management System Management Review Enablers 2011 The Lanese Group Knowledge Management Quality Risk Management 22 ICH Q10 4 June 2008

23 Product Lifecycle Corporate Support and Management Operations Develop Commercialize Discovery Transfer Discontinuation 2011 The Lanese Group 23

24 Product Lifecycle Corporate Support and Management Operations Develop GMPs Commercialize Discovery Transfer Discontinuation 2011 The Lanese Group 24

25 Product Lifecycle Corporate Support and Management Operations Develop Six Commercialize Systems Discovery Transfer Discontinuation 2011 The Lanese Group 25

26 Product Lifecycle Corporate Support and Management Operations Develop Baldrige Commercialize Discovery Transfer Discontinuation 2011 The Lanese Group 26

27 Product Lifecycle Corporate Support and Management Operations Develop ICH Q10 Commercialize Discovery Transfer Discontinuation 2011 The Lanese Group 27

28 Development Change management 2011 The Lanese Group 28

29 Change Change Management 2011 The Lanese Group 29

30 Requirement for change control These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. 21CFR (a) 2011 The Lanese Group 30

31 Requirement for change control The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit The Lanese Group 31 21CFR (a)

32 Requirement for change control Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. 21CFR820.40(b) 2011 The Lanese Group 32

33 Requirement for change control Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. 21CFR820.40(b) 2011 The Lanese Group 33

34 Requirement for change control Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. 21CFR820.40(b) 2011 The Lanese Group 34

35 Requirement for change control Production and process changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to , before implementation and these activities shall be documented. Changes shall be approved in accordance with The Lanese Group 35 21CFR820.70(b)

36 Change Control A formal change control system should be established to evaluate all changes that could affect the production and control of the intermediate or API. ICH Q7; The Lanese Group 36

37 Change Control Written procedures should provide for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, labeling and packaging materials, and computer software. ICH Q7; The Lanese Group 37

38 Change Control Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality unit(s). ICH Q7; The Lanese Group 38

39 Change Control The potential impact of the proposed change on the quality of the intermediate or API 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. ICH Q7; The Lanese Group 39

40 Change Control Changes can be classified (e.g., as minor or major) depending on the nature and extent of the changes, and the effects these changes may impart on the process. Scientific judgment should determine what additional testing and validation studies are appropriate to justify a change in a validated process The Lanese Group 40 ICH Q7; 13

41 Change Control When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised. After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change The Lanese Group 41 ICH Q7; 13

42 Change Control (definition) A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state The Lanese Group 42 EU GMP; Annex 15

43 Change Control (definition) A formal system in which proposed changes are evaluated and monitored to assure that they result in products of equal or improved quality, process of equal or improved efficiency and compliance while maintaining appropriate regulatory submissions. Lanese 2011 The Lanese Group 43

44 Responsibilities of the Change Control Program Review all changes proposed for the GMP facilities, equipment, materials, processes to determine if there is a potential impact on product quality 2011 The Lanese Group 44

45 Responsibilities of the Change Control Program If there is potential impact: Inform all appropriate units of the potential impact. Coordinate appropriate regulatory submissions. Assure that the proposed change is completed in a timely manner and required changes to documentation and other supporting systems are made. Verify that the change achieves its intended purpose The Lanese Group 45

46 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuance Investigational Products GMP Management Responsibilities PQS Elements Process Performance and Product Quality Monitoring System Corrective Action/Preventive Action (CAPA) System Change Management System Management Review Enablers 2011 The Lanese Group Knowledge Management Quality Risk Management 46 ICH Q10 4 June 2008

47 Main objectives of a Quality System Achieve product realization Establish and maintain a state of control Facilitate continual improvement ICH Q The Lanese Group 47

48 P plan A act D do C check

49 Requirements Inputs Overview of a Modern Pharmaceutical Quality System Continual Improvement Act Management Resources Manufacturing Evaluation Plan Do Check Quality System Infrastructure Quality by Design Risk Management Chris Joneckis, PhD, FDA

50 Continual Improvement of the quality management system Management Responsibility Customers Customers Resource Management Measurement, Analysis and Improvement Requirements Input Product Realization QMS Output Product Satisfaction ISO

51 PDCA Plan: Put in place all of supporting system changes to support the overall change Do: Implement the changed process. Check: Verify - Monitor and measure the processes and product against established performance measures Act: Recommend the next change to continually improve process performance

52 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuance Investigational Products GMP Management Responsibilities PQS Elements Process Performance and Product Quality Monitoring System Corrective Action/Preventive Action (CAPA) System Change Management System Management Review Enablers 2011 The Lanese Group Knowledge Management Quality Risk Management 52 ICH Q10 4 June 2008

53 Corrective action/preventive action Development Not applicable, CAPA incorporated into interactive design process Technology transfer Provides feedback on the effectivity of the development process Manufacturing A formal quality system, adds to knowledge database Product Discontinuance Investigations evaluate impact on remaining product and other products 2011 The Lanese Group 53

54 Change Management Development Documents all changes - increases formality of the process as product matures Technology transfer Key knowledge transfer tool Manufacturing Formal system must be in place Product Discontinuance Records maintained and destroyed after retention period 2011 The Lanese Group 54

55 Product Reviews Validate Verify Inspectional Observations Development Change Audit Observations CAPA Deviations Product Monitoring Investigations 2011 The Lanese Group 55

56 Change Management System Change Control System Senior Management 2011 The Lanese Group 56

57 Recommend Change 2011 The Lanese Group 57

58 Product Reviews Validate Verify Inspectional Observations Development Change Audit Observations CAPA Deviations Product Monitoring Investigations 2011 The Lanese Group 58

59 Recommend Change Log into project management system Prepare forms required by CM program Estimate costs 2011 The Lanese Group 59

60 Require Mgmt Approval No No Yes Require Change Control Yes Management approves funding 2011 The Lanese Group 60

61 Manage Change Project Implement Change Initiate CC Forms Define CC requirements, communicate Monitor Change Project 2011 The Lanese Group 61

62 CC Project Yes Perform Verification Tests Evaluate Verification Date 2011 The Lanese Group 62

63 Close out project Meet Criteria Yes Close out Change Control Documents 2011 The Lanese Group 63

64 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuance Investigational Products GMP Management Responsibilities PQS Elements Process Performance and Product Quality Monitoring System Corrective Action/Preventive Action (CAPA) System Change Management System Management Review Enablers 2011 The Lanese Group Knowledge Management Quality Risk Management 64 ICH Q10 4 June 2008

65 2011 The Lanese Group 65

66 Develop a Quality System that fits the business and compliance needs 2011 The Lanese Group 66

67 Contact Information Jerry Lanese Ph.D. The Lanese Group, Inc Catalina Leawood, KS The Lanese Group 67

68 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 The Lanese Group 68

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