USFD Guidelines WHO GMP Guidelines on Validation Requirments of Documents and Documentation

Which documents are required to be keep updated during a Validation or Qualification Activity? 

As per USFDA Guidelines, WHO GMP guidelines on Validation Which documents are required to be updated for conducting a successful validation activity.

1: Validation master Plan, should cover the present validation activity schedule and its revalidation future plan.

2. All SOPS of equipment and Processes should be updated and valid.

3. Specifications of Product, Bulk, Finished Product, or the specified end point of activity conformity indicating values or observations.

4. Protocol as well as validation Report Templates for Validation, its acceptance and signeoff by Operation Heads and QA heads.

5. Any result, observation which indicates CAPA or additional activity to be completed which is an outcome of Risk assessment exercise must be completed and signed off.

6. Process flow chart that actually indicates the process flow of a process being validated, along with a flow chart of the entire validation activity.

7.Approved Validation Manuals.

8.Training activity pertaining to the undertaken Validation activity, training of staff and QA, Production, Operation personnel’s, for Validation Protocol, and Sampling Plan, Testing Plan, Handling of Deviation if any arise during activity, Manufacturing Process, Operation and Cleaning activity. Area monitoring, Calibration Verification, its recording must be completed for all individuals associated with Validation Activity.

9. Approved Sampling Plan, observation frequency in case of validation is based on observational results.

10. Method of Analysis, Testing Plan.

11. Adapted Statistical Methodology, interpretation of results.

12. Policy for Password protection It’s SOP, and Computer System and validation of electronic computer sysety PLC and Programs and Training.

13. Policy for Handeling of Data integraty monitoring, it’s SOP and Training.

15. Policy and SOP about Handing of Deviations during  Validation activity and it’s Training.

14. Periodic Review of Validation Status Future Plan for maintaining Validation status, Plan For Frequency of Revalidation or Revalidation Strategy Based on valid reasoning.

All above documents are required to be keep updated during a Validation or Qualification Activity.

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