Planning to perform audits
I often see auditors who perform audits undertake this activity with little or no planning. As with everything else in life, planning is everything. An audit is much more effective for everyone concerned if the auditor takes a short amount of time to plan the audit correctly. Here is an audit planning checklist to help in the planning of any effective audit:
Make contact with the auditee and agree the date, time, location and scope of the audit. This will include informing them of why the audit is being performed, what areas or activities will be looked at and the standard to be used during the audit.
Clarify the exact location of the audit (where it is to be performed) and check if any key activities that also need to be audited occur elsewhere.
What do they do?
Especially important for supplier audits: what does the organisation do for you and what do you do with what they supply you with?
Do you have any issues with the place to be audited? Have there been any concerns raised? Have there been any product quality issues? What is their performance data, such as how reliable are they? Have any changes been made since they were last audited? This can help create focus areas for your audit.
Review the previous audit report:
This will highlight any concerns raised at the previous audit. It may be worth following-up on any major concerns from the last audit to see if these were dealt with effectively. The report should also show what areas were looked at last time, as it may be better to focus on some alternative areas this time.
Select your team:
Are you auditing alone, or are a number of auditors needed? A Subject Matter Expert may be needed, or at least consulted before the audit.
Select the duration:
Establish how long the audit needs to take – there may be internal guidance within your organisation on this.
Review any documents:
It is a much better use of everyone’s time if you can review any key documents in advance. Ask to see a Quality Manual, Site Master File, Site Layout, Organisation Chart, key Policies or Procedures that are important for the audit. This will also allow for focus areas to be identified. You may not always get them – but if you don’t ask you don’t get.
Produce a programme:
This will show the auditee what areas and processes you want to look at and the approximate times that you are expected.
Review the standard:
Check what the expectations of the standard that you are auditing against are. If you are auditing calibration, see what the standard says about calibration. If you are auditing training, then see what the standard says about training, and so on.
Produce a list of things that you and the standard expect to see when you are looking at specific areas. This will ensure that you have a series of questions already to ask when you are on-site.
Arrange any transport and accommodation:
Especially for external audits, how will to get from A to B, where are you staying and how far is this from the site itself? After all – you don’t want to be late!
Any special requirements?
Are there any special clothing, safety or access requirements needed? Clarification here can avoid wasting time on the day.
Have good communication with the auditee before the audit, so they know exactly who is coming and what to expect during the audit. Send them the programme so they can plan their time as well.
I hope this audit planning checklist helps with your audit planning. If you would like to add any thoughts or comments, then by all means do so. Good luck with your auditing.
If you need any more detail on how to perform effective audits, then consider attending one of our highly praised auditor training courses.
I hope this audit planning checklist is helpful. If you have any thoughts or comments, then just let us know.
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 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.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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