1. A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances.

2. A review of critical in-process controls and finished product results.

3. A review of all batches that failed to meet established specification(s) and their investigation.

4. A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken.

5. A review of all changes carried out to the processes or analytical methods.

6. A review of Marketing Authorisation variations submitted, granted or refused, including those for third country (export only) dossiers.

7. A review of the results of the stability monitoring programme and any adverse trends.

8. A review of all quality-related returns, complaints and recalls and the investigations performed at the time.

9. A review of adequacy of any other previous product process or equipment corrective actions.

10. For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments.

11. The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.

12. A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.

The manufacturer and, where different, marketing authorisation holder should evaluate the results of the review and an assessment made as to whether corrective and preventive action or any revalidation should be undertaken, under the Pharmaceutical Quality System.

Full guidance is taken from Chapter 1 - Pharmaceutical Quality Systems

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