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APQR template

Use this APQR template to improve product quality oversight, ensure GMP compliance, streamline reviews, and stay inspection-ready with ease.

APQR template | Scilife

What’s inside?


Use this ready-to-use APQR template that we have created for you to:

  • Ensure compliance with regulatory requirements, including EU GMP, FDA 21 CFR 211.180(e), and ICH Q10 expectations for product quality review.
  • Provide a structured framework for reviewing product quality, manufacturing performance, and quality system effectiveness over the review period.
  • Define clear quality conclusions, trends, and actions, based on batch data, deviations, CAPAs, changes, complaints, and stability results.
  • Streamline APQR preparation, saving time and reducing risk during audits and inspections.

The handbook collection for smarter compliance

Clear, practical, and always by your side, explore our collection of handbooks and take the guesswork out of quality and compliance.

 

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