GMP Auditing Articles and News
Read our articles on GMP auditing relating to regulatory compliance in the Pharma
This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.read more
Here is a free template for things that you should include in an auditing closing meetingread more
Here is a free template for things that you should include in an auditing opening meetingread more
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.read more
A new challenge for all auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled?read more
When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes. Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see. This makes for a better audit.read more
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!read more
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.read more
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.read more
Our 5-day Pharmaceutical Lead Auditor course is registered with IRCA, the International Register of Certificated Auditors. This is the world's premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses. ...read more
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