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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 pharmaceutical industry – the standard that you will audit against is GMP. It is important that any non-conformities are linked with the standard that you are auditing against, so non-conformities against GMP must be linked to the relevant clause of GMP.

The following may be useful to you. It lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause – but additional clauses may exist. You should also refer to GMP itself to understand fully the context of each clause.

Not following a procedure

5.2/4.1 (new Chapter 4)

Absence of a procedure


Procedure out-of-date

4.5 (new GMP Chapter 4)

Not following a schedule, programme or plan


Internal audits schedule late


Untrained personnel


No GMP training


No job specific training


Item not calibrated


Poor housekeeping/ cleaning


Risk of mix-ups and contamination


Unauthorised entry of personnel


Poor design of drains


Poor temperature control


Doors and windows left open


Incorrect crossing out of data

4.9 (new GMP Chapter 4)

Not completing records at the time of action


Area not identified with batch number, product and activity


Items not labelled


Pipework not labelled


Damage to facility/ equipment


Redundant and broken equipment


Not using pen

4.7 (new GMP Chapter 4)

Use of correction fluid

4.9 (new GMP Chapter 4)

No organisation chart


No job description


No training record


There is no mention in GMP of pen colour, the use of ditto marks, post-it notes or having a specific time and date format. However, if an organisation has a policy or procedure on such things – then they must follow their own system. Otherwise this is a non-conformity against 4.1 and 5.2.

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