Best Practice In A Change Management System

Transcription

1 Quality & Compliance Associates, LLC Best Practice In A Change Management System

2 President Quality & Compliance Associates, LLC

3 Change Control and Its Role in a Continuous Improvement Environment 3

4 Benefits of An Effective Change Control System. Structured and consistent approach towards managing change Documenting the details of change Routing of change requests to appropriate individuals/team for approvals Documentation of change approvals and implementation Maintenance of change history and easy retrieval of information Tracking changes effectively Demonstrate compliance to FDA regulations 4

5 Change As A Quality Tool ICH Q10 FDA Quality System Audit PIC/S Pharmaceutical Inspection Conventions EMEA Guidelines ISO Documents 5

6 ICH Q10 Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company should have an effective change management system. The change control process is critical to ensure that change is controlled and approved for all phases within the pharmaceutical environment. ICH 10 links key elements to the stage of the process life cycle. 6

7 Q10 Key Elements Quality risk management should be utilized to evaluate proposed changes. Proposed changes should be evaluated relative to the marketing authorization. Proposed changes should be evaluated by expert teams contributing the appropriate expertise and knowledge. After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and there were no adverse impact on product quality. 7

8 Q10 Application of Change Management System in Lifecycle Development Technology Transfer Product Discontinuation Commercial Manufacturing 8

9 FDA Drug Manufactruing Inspections Program Quality Systems Approach to Investigations Focuses on Six Quality System including: Quality Faclities and Equipment Materials Production Packaging and Labeling Laboratory 9

10 Key Elements of Each of the Systems Control System for Implementing Changes 10

11 PIC/S Pharmaceutical Inspection Convention 11

12 Pharmaceutical Inspection Convention CHANGE CONTROL 43. Written procedures should be in place to describe the actions to be taken if a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications. 44. All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for, and the extent of, requalification and re-validation should be determined. 12

13 Start of A Change Control Evaluation 13

14 When Should A Change Control Process Begin? Change Control Development Technology Transfer Commercial Manufacturing Product Discontinuation 14

15 ONE POSSIBILITY 15

16 Development Change control should begin when the process is determined. Registration batches Clinical batches Batches used to support regulatory submissions. May be an abbreviated process. Depending on the point in the development process, flexibility in scope of changes and approval may be different. 16

17 Technology Transfer Movement from a development/r&d mode to a commercial manufacturing environment. Validation is implemented. Critical control parameters established and confirmed. If change is not controlled well during development then the technology transfer will become more difficult. 17

18 Discuss Some Transfer Pitfalls Solid Dose Forms Parenterals 18

19 Commercial Manufacturing Quality Facilities and Equipment Materials Production Packaging and Labeling Laboratory 19

20 Specifications Methods Document Equipment Packaging Processes Suppliers API Raw Material EXAMPLES OF CHANGE TYPES 20

21 Three Fundamental Questions What might go wrong? What is the likelihood (probability) it will go wrong? What are the consequences (severity)? 21

22 Questions To Ask Why is the change needed? Necessity Improvement Regulatory What quality systems are impacted? What are the regulatory implications? What are the product implications? Are there validation implications? Has there been an appropriate technical evaluation? What is the time frame for implementation? 22

23 Risk Assessment in the Change Control Process ICH 10 - Quality risk management should be utilized to evaluate proposed changes. 23

24 ICH Q9 Quality Risk Management 24

25 Risk Assessment Process ICH Q9 Model Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable Risk Control Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process Risk Review Review Events 25

26 Process Risk Identification Risk Analysis Risk Evaluation 26

27 Risk Identification Identification of hazards such as critical controls points in a process. Evaluation of a process using risk assessments and historical evaluations. Answers the question What might go wrong 27

28 Risk Analysis Estimation of quantitative or quality risk associated with the defined hazard. Likelihood of its occurence. Affect on product safety. 28

29 Risk Evaluation Data is critical to evaluation!!! Data can be either qualitative or qualitative. Robustness and reliability of data is critical. Where are the data gaps and how can these gaps be remediated. How can risk factors be measured either in a variable format and in qualitative format. 29

30 Remember The Goal is to minimize risk and simply not to accept. The end result should be not only an evaluation but also the goal to minimize and control. 30

31 Risk Management Methodology Basic Risk Management facilitation methods Failure Mode Effects Analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Preliminary Hazard Analysis (PHA) Risk Ranking and Filtering Supporting Statistical Tools 31 31

32 Basic Risk Management Facilitation Methods Flowcharts Check Sheets Process Mapping Cause and Effect Diagrams 32

33 Q10 Proposed changes should be evaluated relative to the marketing authorization. Regulatory Affairs Determine impact of change to the regulatory filing Filing restrictions will determine when changes can be implemented. Assure that appropriate controls are in place. 33

34 Q10-Proposed changes should be evaluated by expert teams contributing the appropriate expertise and knowledge. Who Are the Experts? 34

35 Regulatory Affairs QA QC Others Potential Expert Team Members R&D Engineering Operations Information Technology Technical Services 35

36 Q10 - After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and there were no adverse impact on product quality. 36

37 Stages of A Change Control Proposal Acceptance Implementation Confirmation 37

38 Two of the Weakest Links is Either the Change Control is Not Done or It Is Not Implemented Appropriately 38

39 Success Stores and Their Challenges 39

40 Establishment of Change Control Within Organization Structures Example Initiator QA Change Control Committee CC Coordinator CC Committee Member 40

41 Initiator Assures compliance with process and procedure. Completes the appropriate documentation. Obtains the appropriate initial evaluations. Acts as the sponsor and facilitator of the CC. Presents the changes to the SME committee. 41

42 Change Control Coordinator Ensure that the documentation is complete Approves change for circulation. Reviews for duplication. Schedules meeting for change control committee. Publishes agenda and minutes for CC committee. Maintains CC database along with tracking. Maintains KPI s for CC. 42

43 Change Control Committee Member Performs technical evaluations for their respective areas. Approval completed documentation. Final approval of implementation confirmation. 43

44 QA Chair the CC Committee. Provide guidance on compliance and technical issues. Provide final review and sign-off for both the request and the completion of the change. 44

45 Key Performance Indicators Measure of success. Timeline compliance. Completion. Effectiveness Measures. Repetitiveness 45

46 Keep Metrics In Front of Senior Management i.e. Quality Council 46

47 Implementation of Change Control As a Quality System 47

48 Ways to Monitor and Track Changes List of changes maintained by a central area such as a change control coordination group. This should be one list. Electronic system such as trackwise or equivalent. Two critical elements to measure. Approval of request. Approval of completion or implementation segment. 48

49 Determination of Best Ways to Control Changes Corporate policy. Centralized control system within each site. Site gatekeepers. Tracking systems Verification system KPI Metrics 49

50 Examples of Change Control Organizations Such as Review Boards. Actual review board meetings. There can be scheduled meetings. Meetings as required. Referee systems. There may not be actual meetings. Electronic reviews Gatekeepers to coordinate questions. Initiator to answer questions. SME to provide guidance 50

51 Documentation Requirements for Change Control 51

52 How Many CC Procedures Does Your Organization Have? 52

53 General Types of Changes Documentation Raw Material Components Equipment Equipment Facility Utilities Computer System Process 53

54 Ensuring That Documentation Does Not Hinder the Process 54

55 TYPES OF FORMS Change proposal and initiation. Change implementation and approval. Verification. 55

56 Issues With Initiation Proposed change unclear Scope is too general or not defined. Actual change is not defined. Requirements not defined. Reason for change not clear. If change must be delayed due to completion of change requirements, tracking can become difficult without an appropriate system. 56

57 Quality Tool A good change control system will add value and should not be perceived as a hurdle to be avoided. There should be a group or individual to help expedite the CC process including the paperwork. The response from critical organizations such as regulatory affairs must be timely and decisions given quickly. Emergency changes should be minimal. 57

58 Verification and Control 58

59 Verification Tools to Confirm Appropriate Implementation Verification will be easier if the change control was concise with pre-determined acceptance criteria. QA is the final approver to determine that the event and system is working. Attempt to make success measureable. Validation execution. SOP completion. Training. Regulatory filings. Qualification 59

60 Roadblocks to Success Change control process is overly bureaucratic. Change controls lack supporting data. Changes are too nebulous and general. Measures to determine effectiveness are not predetermined. 60

61 Thank You Questions? 61

62 President Quality & Compliance Associates, LLC