The pharmaceutical industry is full of procedures. This is why GMP is often jokingly re-named to Great Mountains of Paperwork. Whilst the importance of having good quality procedures in place is vital I often see a focus on getting small problems with procedures corrected and then often missing the bigger issue – is the document any good?
What is important is that our procedures are accurate and correct. However I see lots of examples where new versions of procedures are not authorised because of a minor typing error, or typo, such as the word “and” being spelt incorrectly for example. Whilst it is important that procedures are accurate and easy to understand – we do sometimes get obsessed with having them word-perfect. This may not be as important as you might think. Feel free to read the text below – it is full of typos.
“Acconig to a rscheearch at an Elingsh uinervtisy, it deosn’t mttaer in waht oredr the ltteers in a word are, the olny iprmoetnt tihng is taht frist and lsat ltteer is at the rghit pclae.”
Most of you will read this and it will make perfect sense. So perhaps we shouldn’t worry too much about the odd typo in a document if it is not going to cause any problems.
A better area of focus for those reviewing and approving new procedures is to ensure that they actually reflect working practices and are going to be understood by the end-user. Not consulting the end-user in the design and content of documents is one of the main reasons (that I see) as to why documents are either not used AND why so many documentation errors occur.
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.
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Very cool post. Something I find even worse than nitpicking grammar and punctuation, is when reviewers/approvers simply sign off on the front page without looking at the content at all! I would almost prefer an overly detailed reviewer rather than someone who is just going through the motions.
You have to be very careful as Documentation errors lead to huge GMP issues. Example: Wrong formulation just because the decimal was inadvertently put in the wrong place messing up the entire formulation, resulting in a failed batch.
While the minor grammar and punctuation errors, could be corrected by Document Control personnel within a procedural document, the overly detailed reviewer must really reject grammatical and punctuation errors as well if these impact the meaning of the technical, compliance and quality requirements within the document. Sloppy documents must not be accepted.
Documentation errors could result in serious GMP issues. It is very important the Good Documentation Practices SOPs and/or training clearly defines what is acceptable and what is not.
Document review procedures should define the requirements for review and approval of documents by Subject Matter Experts (SMEs), Quality Assurance Reviewers, Document Control and other reviewers as applicable to the document. A risk based approach is important and must not be overlooked.
The document will never be perfect but it must meet technical, compliance and quality requirements.
Hi All I would like to know if there is anywhere I could get my hands on some samples for document errors i.e. the right and wrong way to correct an error, the importance of not leaving blank spaces, how and when to use n/a, etc. any ideas would be greatly appreciated. P.S. I am not directly involved in the industry but prepare individuals to seek work in the industry
I agree with Dominic and also with Shay. But now I am going to be controversial. For documents that are going t be read and followed, mainly BMRs, dispensing procedures, QC tests, I totally agree with Shay. However, a good proportion of SOPs are viewed only when initially trained on, reviewed or when put in front of an inspector. I rarely see operators in the manufacturing area with an SOP in front of them when doing their normal job. BMRs, yes. The folders of SOPs are usually nearby but are only occaisionaly looked at. Even the recent revision of Chapter 4 on Documentation has removed the requirement for SOPs to be available at the point of work! So the questions to ask – (1) Are we writing documents to satisfy regulatory inspectors or to ensure effective manufacturing and a safe product? (2) If the documents are to be used why are people not using them.
The content of most SOPs consists of several chapters such as responisibilities, definitions etc which take up more pages than the instruction required to do the job!! Why are most companies’ SOPs structed with Title, Scope, Definitions, Responsibilities, Associated Documents, References etc? There is no regulated requirement for them to be structured like this. If a document is to be used make it user friendly and not a tome that has studied to find the bit of information that is needed.
I agree with all the views, starting from the author down to the commentators. However, as a QA personnel who is in-charge of documentation, I would say that the way a document should look like, what to accept or not, depends on the guidelines given in the SOP for SOPs and other protocols for writing other documents. This is achievable through consensual agreement between the end user and the reviewers at the time the document is first written.
We have to know that every management has a system and their norms. So there is not general norm of documentation that cuts across all companies at the same time. But there are some general regulations that provide quality.