Good Distribution Practices Toolkit Change Control 10 March 2016

Transcription

1 Good Distribution Practices Toolkit Change Control 10 March

2 Disclaimer The content of this presentation were derived mainly from WHO training material on Change Control and edited to suit the Distributor Operations. 2

3 Definitions Any proposed change that requires an evaluation to determine the impact of any of the following: - Regulatory Filing - Validated state of device design, GMP system, facilities, equipment or of validated methods - Product quality attributes or critical parameters/functionality Change Record: A system through which the effects or risks of changes initiated in the GMP environment are controlled to a predictable level. Roles and Responsibilities should be documented with all appropriate stakeholders involved in initial assessment and throughout change record lifecycle. 3

4 Definition In the WHO-GMP guideline glossary there is definition of the term change control However, the GMP guideline basically contains only few notes about the handling of changes 4

5 Why Controlling the Change? 14.3 Procedures should be established and maintained for the preparation, review, approval, use of and control of changes to all documents relating to the distribution process. Procedures must be in place for both internally generated documents and those from external sources. WHO-GMP 5

6 Change Control Ensures That Properly assessed by all applicable functional or site experts (including Regulatory Affairs), and approved by QA Contacts before implementation Implemented according to approved plans Properly documented Assessed after implementation to ensure that changes are in control 6

7 Principles of change control Each change to previously approved requirements requires a review and authorization to keep the system in its original state of proven suitability Formal change control guarantees that all changes are evaluated for their effect on product quality or validation status Change control minimizes the risk that changes can have on the quality or process characteristics Change control programs have become recognized as essential element of the pharmaceutical quality assurance system 7

8 Change control programs Change control helps to maintain the validated and established status. Validated processes and qualified facilities can be influenced by changes and products no longer comply with specifications 8

9 Scope of change control Change control is not department-specific, rather the task of the whole company The change control monitors all types of changes which can influence the process or product quality and states the measures necessary for implementing the change or decides that a change should not be implemented 9

10 Change control Team An important function as part of the change control program is fulfilled by the change control Team (change control board) The task of this team is to evaluate the changes, establish and coordinate measures to put in place and authorize the changes 10

11 Typical Stakeholders Change Owner Quality Regulatory Engineering / Calibration Validation Partner Client Subject Matter Experts (SMEs) Information Systems (IS) 11

12 Change Control SOP Change control requires a written procedure First point for Audit Covers the overall approach Roles must be clearly documented Ensure cross-functional evaluation of the proposed change 12

13 Initiation Change Record lifecycle Impact assessment Define pre-implementation and post implementation tasks Owner and QA approval of tasks Completion of pre-implementation Approval to implementation Completion of post implementation tasks Closure of change record 13

14 Process Changes requiring control are generally documented in the form of a change request in which the applicant for the change proposes the type of change, suggests the timeframes and measures for carrying out the change The change control team authorizes or not the change The documentation for the change procedure should show that the change was evaluated (risk analysis) 14

15 Documentation Change control procedure includes flow chart of the change control process and the change request form (or change form) Change request form records a request for change so that each change is documented before it is approved The change request form includes the description of the change, the benefits, costs, urgency of the change, change impact 15

16 Change control procedure: flow chart (example 1) 16

17 Change control procedure: flow chart (example 2) More information required Change Request Submission Evaluation of Change Impact Change Activities Validation Change Request Change Activities Approval Approval Activities Completion Activities Completion Change Closed 17

18 Change control procedure: flow chart (example 3) 18

19 Change control procedure: flow chart (example 4) CCB = change control board 19

20 Change control procedure: flow chart for change master documents (example 1) 20

21 Change request form (example 1, 1/2) 21

22 Change request form (example 1, 2/2) 22

23 Change request form (example 2, 1/2) 23

24 Change request form (example 2, 2/2) 24

25 Change request form (example 3) 25

26 Sample change record form 26

27 Sample change record form 27

28 Documentation All quality-relevant changes should be documented All actions to be taken, including the need for and extent of qualification or validation, should be described The records can be archived in paper form or electronically When storing documents, raw data and other relevant documents for change should be kept accessible 28

29 Documentation Change control logbook Page: of Change control logbook (year: ) Nb. Request date Requester / departmen t Item Description Approval date Actions and time limit Closing date QA Manager signature Date

30 Auditing Change Control Change Control standard operating procedure Check that all relevant steps for change control implementation are detailed Choose some applications (from the list in the logbook) Verify the applications and all requested documents (change request form, investigation, request and closing date) 30

31 Questions and Answers 31