GMP Auditing Articles and News
Read our articles on GMP auditing relating to regulatory compliance in the Pharma
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?
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.
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!
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.
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. ...
When you are auditing you will often find non-conformities. These occur when the department, process or organisation that you are auditing is not following a requirement of the standard that you are auditing against. For many of you who perform audits in the...
I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with the flow”.
Most people will have some involvement with being audited. In general audits are classified into one of three different types; namely first party, second party and third party. First party audits are often called internal audits or self-inspections. Here you are...
No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner.
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