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.
If you have some GMP news you would like us to publish then please contact us.
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.
A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the standard actually states that you should follow your procedures? On investigation this is not as easy to find as you might like to think!
Every year or so someone in a pharmaceutical organisation will say “It’s time to think about GMP training again”. This statement will usually be received with little enthusiasm from those who hear it…
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In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It surrounds the use of the word “procedure” and what is meant by a procedure.
In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.
When non-conformities are raised during audits a sequence of events needs to follow afterwards in order to deal with the non-conformity correctly. This post highlights the main process that good auditors should use, as well as highlighting any potential problem areas.
The pharmaceutical industry is full of procedures. This is why GMP is often jokingly re-named to Great Mountains of Paperwork. Whilst the importance of having good quality procedures in place is vital I often see a focus on getting small problems with procedures...
The setting of a date to close a CAPA is a good idea. It provides a target to work towards. However, setting a blanket “one-size-fits-all” date to close all CAPAs often causes further problems – find out why
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.
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