QP News and Articles
Read our articles on regulatory developments of interest to trainee and qualified QP’s as well as news about our pharmaceutical training courses. The 3 most recent QP articles are shown in the slider and the rest are shown in date order below.
From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of the Engineering Manager is therefore critical.read more
From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP. EU GMP does require you to have a QA system, but there is no mention of who should manage the system. In a number of courses that I have presented in the past...read more
Duties of key personnel in GMP – Part 1 (Production, QC and the QP)Three key personnel are named on a pharmaceutical manufacturing site’s Manufacturing Licence. These are the Head of Production, the Head of Quality Control and the Qualified Person(s). Their roles...read more
This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel. As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is...read more
A lot has been said about ISO 9001 in the pharmaceutical industry. This article tries to compare the two fairly. You should read Part 1 first to get some idea of the differences. One of the main problems of comparing GMP and ISO is that the two standards are not...read more
A lot has been said about ISO 9001 in the pharmaceutical industry. With pros and cons and comparisons to GMP made all the time. This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001 below. Those in purple text are...read more
What’s new in the latest version? The EU GMP Chapter 5 on Production is currently being reviewed. A draft update document is currently available. This article is a commentary on the DRAFT version currently in circulation. Many of the suggested updates are in-line...read more
What’s new in the latest version? The EU GMP Chapter 4 on Documentation came into force on 30th June 2011. Many of the updates were in-line with existing good practices. Some of the main changes are summarised below. You should refer to the actual...read more
The deadline for public comments on the concept paper on revising EU GMP Annex 16 - Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012. Problem statements (from the concept paper) What is the minimum a...read more
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