Change Control.pptx

Change control within a QMS is a formal process used to ensure that a change to a system is introduced in a controlled and coordinated manner.

1. Change Controls in Pharmaceutical M anufacturing By: Kester Anyadiegwu Sr. QA Specialist

2. Discussion 2

3. What is Change Control? 3

4. Principle of Change Control 4

5. Written Procedure 5

6. Documentation All change control should be documented D ocumentation is the key to GMP compliance and ensures traceability Documentation provides the route for auditors to assess the overall quality of operation within the company and final product 6

7. Knowledge Management 7

8. Quality Risk Management 8

9. Process of Change Control 9

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12. Review and Approval 12

13. C ommunication : QA Department will communicate the status of the change control process to the initiating department. Training : Before the initiator department starts implementing the change, the Quality Department will train the department to implement the change smoothly. The Quality Department will highlight the required activities with deadlines for effective implementation. eQMS software: D ocuments employee training P roven method for showcasing training effectiveness after a change. (Ex. ISO, VEEVA, BLUE MOUNTAIN) T he system allows you to easily present audit-ready training evidence during regulatory audits The Roles in Quality 13

14. Implementation 14

15. Evaluation Lastly, the initiator department will be evaluated to track the change control process’s progress and ensure satisfactory implementation.   15

16. Change Control in Pharma How Do I Initiate Change Control in the Pharmaceutical Industry? Change control in the pharmaceutical industry is initiated using a change request form. The initiator department’s personnel will provide all the relevant information in their relevant fields s uch as, the originator, originating department, existing process, proposed activity/change, risk a ssessment, and reason of change. 16

17. Change Control vs. Deviation The main difference between change control and deviation is that change is an updated stage that conforms to the regulations and quality principles. D eviation is also an updated stage that does not conform to the regulations and quality principles. 17

18. CASE STUDY A new site went live with the Veeva Vault Edms from a paper document system that had been in place. The business administration and investigation owner associate changed the overlay in the production environment to the agreed standard. Those representatives misunderstood the requirements and initiated the change without a change control based on the agreed upon standard for the overlay. Root cause = OVERSIGHT Poor communication Poor turn road Ineffective documentation Training not integrated with change (adequate training of personnel is a prerequisite in both FDA and ISO environment) 18

19. Case Study: Implementation and Evaluation The admin conducted the investigation contained in this event, and sufficient awareness was considered established. With the manual process in place, the audit trail provided by Veeva, and the heightened awareness brought to the representatives about this investigation, no further actions were required. 19

20. Thank You 20

21. Change Controls in Pharmaceutical M anufacturing By: Kester Anyadiegwu Sr. QA Specialist