GDP & RP News and Articles
Read our articles on GDP and Responsible Person (RP) regulatory developments as well as news about our courses in this area. The 5 most recent articles are shown in the slider and the rest are shown below.
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.
The European Union’s GDP guidelines were updated on the 7th March 2013. This article is a simplified overview of the new GDP guidelines and features an opportunity to download a copy of the full Guide.
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!
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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...
Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit. This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
The ISO 9001 standard is the international standard for Quality Management Systems. During its review in the late 1990 they removed its "obsession" of needing a documented procedure to cover most tasks. This is because organisations vary in size and complexity, and...
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