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Basic audit findings and clauses

February 28, 2012

Dominic Parry

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Procedure out-of-date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.

Please feel free to comment. Please visit our main web-site for GMP and Auditor related training courses we offer.

8 Comments

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  1. MOHANKUMAR #
    February 28, 2012

    Good one . CAPA details needed for the observations.

  2. March 1, 2012

    You definitely hit on some of the popular findings I see all the time during cGMP audits! I always find it amazing how much we can read between the lines of the regulations. Take for example the US GMP regulation on equipment design which basically states that “equipment shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use.” That simple statement has ballooned into complex equipment validation, detailed change control, and intricate maintenance programs.

    There’s a nice newsletter out there called GMP Trends which gives a nice monthly summary of FDA 483 observations.

    Really enjoy your blog and look forward to more posts!

  3. T.B.Kumar #
    March 2, 2012

    Sometimes training records are found to be a mere paper work. During an vendor audit, I found a chemist trained in a particular analysis. When I was asking for how the calculation is arrived at, the concerned p[erson could not reply. Also, for out of specification, different versions are noticed. No common version could be found out. This is because of the complexity of the expressions/terminologies used in making the out of specifications.

  4. Nollaig #
    June 11, 2012

    I like this article and agree with other commentator regarding business based citations provided sense prevails and the auditor doesnt get too attached to the number he/she generates! These might best be recorded as “Comments”- this is what I have seen done before.

    • T.B.Kumar #
      June 12, 2012

      I agree to the above comments. I need to quote one example I came across. The company cleared a regulatory audit a week before. When a QA personnel from some other factory audited the firm for vendor approval, he could generagte around 20 NCs. Ofcourse, 5 of them were major and rest were minor. The firm attributed top the lineant view taken by its employees that they had cleared an international audit. So, people work only for audits. If the system is followed regularly, then there will not be any non-compliant. My boss used to say that we ahve to work as if everyday is an audit day.

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