If you perform supplier audits then there are a few things that you should consider. Firstly, ensure you received good training in how to audit. This will make for a better audit and will help to ensure you represent your company professionally. Secondly, try and shadow an existing auditor for a few audits first in order to get a feel for the audit process. As your experience grows then you should get more confident. Eventually though you may end up with a new challenge for all new auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled?
Firstly remember it is not impossible to perform an audit in a foreign language and these happen all the time. Here are a few tips that may help the process.
Clarify in advance what language they speak. Can you speak this language? See also if you can get a feel for how well people speak your language. If you can speak English, for example, then you may well be in luck – as lots of people speak English as a second language.
Take someone to help you translate. You may be able to take someone from your own site or an affiliate in the country you are auditing who can help you with translation. You can, of course, take a professional translator – but this usually adds a fair amount of cost to the audit.
Get documents in advance. A lot of organisations will send you information in advance of performing an audit. If you can get some key documents and procedures beforehand then you can get these translated in advance. This can be done professionally or you may use many internet based tools which, whilst not perfect, should give you a feel for the content of a document. Also ask if the organisation has any translated documents already available – they may be audited many times and have versions of key documents in multiple languages.
Plan for more time. If people don’t speak the same language as you then it will be worthwhile planning for the time needed for any translation to occur. This may mean it takes twice as long to review a document. Either have a longer audit or focus on fewer areas.
You can still look at things. Whilst it may be that nobody speaks a word of your language and every document you see is in a foreign language you can still visit the site and get a feel for the organisation. Facilities, equipment, layout, storage conditions and what people wear are not dependant on language, so you can still get an understanding of how the organisation works. You can also see if they have procedures (OK – you may not understand them and may need to be talked through them) and you can still see if reports, records and log books exist and if they are completed properly.
Make a note in the report. Finally, it is always worth mentioning in the report if language barriers were an issue during the audit. In other words, if you audited in France and you cannot speak French then this will be worth stating.
I hope this brief post is useful. I have just done two audits in Brazil and I cannot speak a word of Portuguese. The audits went well and I had the help of a local representative to assist me.
If you want to see further information on the auditor training courses that we offer select some of the links in this article. Feel free to add your own comments and experiences to this post.
Dominic
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 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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The article has some very good points. I would add that even if the hosting organization of a foreign audit can speak English remember to speak slowly and clearly. You might want to tell them as part of your opening statements. Let them know it is for their and your benefit to make sure of clear communication.
Rusty