Describe the APQR. OOS, Process Validation. And many more

Question

Accepted Answer

APQR is a quality document that summarizes the results of an annual product quality review.

APQR stands for Annual Product Quality Review.
It is a quality document required by regulatory authorities.
APQR summarizes the results of an annual review of product quality.
It includes data on manufacturing processes, analytical results, complaints, deviations, and other quality-related information.
APQR helps identify trends, potential issues, and areas for improvement.
It is an important tool for ensuring product quality and compliance.
OOS (Out of Specification) refers to test results that fall outside the predetermined acceptance criteria.
Process validation is the documented evidence that a process consistently produces a result meeting predetermined specifications.

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