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
Absence of a procedure
Not following a schedule, programme or plan
Internal audits schedule late
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
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
Use of correction fluid
No organisation chart
No job description
No training record
Poor control of deviations
No root cause analysis
Inadequate change control
Poor control of suppliers
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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Good one . CAPA details needed for the observations.
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!
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.
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.
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.
Excellent , Thank you for this .
See item 1.b. Post-it’s are typically related to, or considered “scratch paper”
There also used to be an FDA guidance that does specifically state records should be in “blue or black indelible ink”, although I can’t recall which one now. Up to you as to which color or either.
And the FDA has preferred dating for expiration dating. They expect you to have defined the date format for your organization and follow whatever you choose to avoid confusion…although I’ve never heard nor seen anyone being written up for using a specific format.
A lot of the GDP practices you mentioned not being covered by GMPs are considered “implied” since these are legal documents. Try signing a home loan in red or green ink. These may vary by country to country. For example the FDA used to not accept the common Asian practice of using a stamp as a signature, however, they now appear to allow that.
These aren’t covered under GMP, they are extensions of the criminal code in the U.S. Specifically title 18 of the USC, obstruction of justice.