12.09.2022

How do APR and PQR differ in terms of the number of batches to be assessed in the review period?

While all batches have to be checked for the specified issues in the EU GMP Guide for the PQR, 21 CFR 211.180(e) requires a representative number of batches for the APR. There is however also a requirement to ensure that changes or irregularities are taken into account.

[GMP Compliance Adviser, Chapter 1.J]