GMP News and Articles
Read our articles on pharmaceutical GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP news articles are shown in the slider and the rest are shown in date order below.
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In this article, we move onto the personnel section, section 7.
In this article we expand upon the equipment section but looking at Utilities as described in section 6.
In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.
This article explores Annex 1 Section 3, the Pharmaceutical Quality System highlighting requirements beyond those in EU GMP chapter 1.
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”.
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”.
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...
This is a commonly asked question on my training courses which is generally misunderstood. Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.
Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit. This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.
This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.
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