Annex 1 2022 Section 5: Equipment
In the last article, I described the premises requirements for sterile product manufacture. In this article we look at the general requirements for the equipment used in the manufacturing of sterile products. Depending on the complexity of the equipment Annex 1...
Annex 1 2022 Section 3: Pharmaceutical Quality System
In this fourth article I shall explore Section 3, the Pharmaceutical Quality System. This is a short section aimed at highlighting the additional requirements beyond those also required from EU GMP chapter 1. It is important to remind ourselves that Annexes are...
Annex 1 2022 Section 2: Principle
In the last article, I discussed the scope of the latest update to Annex 1. In this article I want to focus on section 2, “Principle”. The fundamental basis upon which Annex 1 is now build is written into the principle and its associated clauses. It covers elements of...
Annex 1 2022 Section 1: Scope
In the first article I summarised the background to the latest update to Annex 1. In this article I want to focus on sections 1, “Scope”. The scope of a document is usually intended to outline the range of application of the document. It can be used to summarise areas... Annex 1 2022 Introduction and background to the update
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to...
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