What is the Annual Product Quality Review (APQR)?
Working in the pharmaceutical industry, we are obliged to perform the Annual Product Quality Review, although it may be called variously: Annual Product Review – APR (FDA) or Product Quality Review – PQR (EU, ICH7), the idea of such a review is one: it is an organized,
Implementation of GMP requirements in industries outside the pharmaceutical sector
The implementation and maintenance of the GMP system is a highly challenging, time-consuming, often tedious, and demanding task. It is so burdensome that most individuals working within this system would respond negatively to the question of whether to implement even elements of GMP if it is not directly required by law. The topic is very […]
Factory and Site Acceptance Tests
The primary objective of this article is to provide an overview of the comprehensive topic of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). It begins by defining the core differences between the tests, moves on to the stages of test planning, defines the participants in FAT tests, etc.
The first stage of implementing a new manufacturing area — good and bad practices
This article presents observations on the performance of work related to the commissioning of a new area at the initial stage of investment.
