Pharmaceutical Quality Systems Flashcards
What are the expected sections of a PQR and where would you find these?
Eudralex Volume 4 Chapter 1 - PQS:
Review of starting materials
Review of critical in-process Controls and finished product results
A review of all batches that failed to meet specs and their investigation
A review of significant deviations and non-conformances
A review of all changes carried out to the process or analytical methods
A review of marketing authorisation variations submitted, granted or refused, including those for third country(export only dossiers)
A review of stability program and adverse trends
A review of all quality related returns, complaints and recalls and the investigation performed at the time
A review of adequacy of any other previous product process or equipment corrective actions
For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments
The qualification status of relevant equipment and utilities
A review of contractual arrangements as defined in chapter 7 to ensure they are up to date
