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.
The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.read more
Some of the most popular articles on our blog are the four we published some four years ago about the duties of key personnel in GMP. For more recent visitors to the blog I thought it might be helpful to remind everyone about this resource.read more
Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.read more
It is no longer clear in GMP exactly who should review batch records!read more
A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes.read more
After a longer period of review and many draft versions published the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes.read more
In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP). In this post we look at the organisation of these people within the business.read more
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
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We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
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