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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Procedure out-of-date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.

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

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

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Our 2-day course is updated for Annex 1 changes

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