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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

4.1/5.2

Absence of a procedure

5.2

Procedure out-of-date

4.5

Not following a schedule, programme or plan

4.1/5.2

Internal audits schedule late

9.1

Untrained personnel

2.10/2.11/5.1/6.1

No GMP training

2.11

No job specific training

2.11

Item not calibrated

3.41

Poor housekeeping/ cleaning

3.1/3.2

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

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

Use of correction fluid

4.9

No organisation chart

2.2

No job description

2.3

No training record

2.9/4.29

Poor control of deviations

5.15

No CAPAs

1.4xiv

No root cause analysis

1.4xiv

Inadequate change control

1.4xii/1.4xiii

Poor control of suppliers

1.4vi/5.27-5.29

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.

Please feel free to comment.  For details of our courses in this area select this link: QMS Courses

THIS ARTICLE WAS FIRST PUBLISHED IN 2012 AND MOST RECENTLY UPDATED IN AUGUST 2022.

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