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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I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.
Just a reminder that the new EU GMP Chapter 1 on Pharmaceutical Quality Systems and Chapter 7 on Outsourced Acticities come into operation today (31st January 2013). To read my posts on these from last year and to see in actual text click on the links. If you need...
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…
Use Inspired Pharma to deliver your next Pharma compliance training programme deploying either our effective online learning courses, our GMP experts or use both for maximum impact
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.
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