Checklist for Audit in Regulatory Affairs : Pharmaguideline

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Checklist for Audit in Regulatory Affairs

Pick any product randomly and check the details.
1. Whether the specification for product / API matching with the submission?
2. Analytical method is matching with the submissions?
3. Are specifications and test procedures are available for:
  • Raw Material
  • Packaging Material
  • In-process
  • Intermediates
4. Are matching with the claims made in the submissions and compliance file?
5. Check the Manufacturing process is matching with that submitted to the regulatory body/ business partner (s).
6. Review the list of change (s) made in the facility, manufacturing process and documents (SOPs, Specifications, BPRs, Test methods, protocols etc.) during the period.

7. Check that the changes have been informed and prior permission (if warranted) has been received from the regulatory body.
8. Whether the change (s) notified business partners, Advance/Local Market (if Yes, Specify the name (s))
9. Whether the changes have any effect on the commitments made to regulatory bodies?
10. Any other observation (s) need to inform to the regulatory body/business partners Advance/Local Market
11. Whether the commitment made for compliance with the regulatory audit observations are being followed?
12. Evaluate, if there is any need of filling a supplemental/variation application?
13. Whether annual submission/compliance report updated/Submitted?
14. Whether there is a checklist that is followed for a particular product / particular market & is being updated regularly?
15. Whether all ANDA. ANADA & DMF documents available in the department?
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Get documents for Audit preparation in MS-Word FormatView List

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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