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

5.2

Procedure out-of-date

4.5 (new GMP Chapter 4)

Not following a schedule, programme or plan

4.1/5.2

Internal audits schedule late

9.1

Untrained personnel

2.8

No GMP training

2.9

No job specific training

2.9

Item not calibrated

3.41

Poor housekeeping/ cleaning

3.2

Risk of mix-ups and contamination

3.1/3.7/3.8

Unauthorised entry of personnel

3.5/5.16

Poor design of drains

3.11

Poor temperature control

3.3

Doors and windows left open

3.3/3.4

Incorrect crossing out of data

4.9 (new GMP Chapter 4)

Not completing records at the time of action

4.8

Area not identified with batch number, product and activity

5.12

Items not labelled

5.12/5.13

Pipework not labelled

3.42

Damage to facility/ equipment

3.3/5.4

Redundant and broken equipment

3.44

Not using pen

4.7 (new GMP Chapter 4)

Use of correction fluid

4.9 (new GMP Chapter 4)

No organisation chart

2.2

No job description

2.2

No training record

2.9

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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