There are many activities that you do that are “procedures”, such as how you get in the car in the morning (unlock the door, adjust the seat, fasten seat-belt, start the engine, and so on), but this is (hopefully) not a “documented procedure”! “Documented procedures” are often referred to as Standard Operating Procedures (SOPs), but they do not have to be called these.
The list below details the documents required by EU GMP as “documented procedures”. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.
- Quality Manual (Chapter 1 Clause 1.7 (1.7))
- Quality Policy (2.4)
- Site Master File (Chapter 4 Principle)
- Product Specification Files (4.2)
- Manufacturing Authorisation (4.2)
- Marketing Authorisation (4.2)
- Specifications for starting and packaging materials (4.14)
- Specifications for intermediate and bulk product (4.15)
- Specifications for finished product (4.16)
- Manufacturing formulae for each product (4.17)
- Processing instructions (4.18)
- Packaging instructions (4.19)
Procedures for:
- Receipt of deliveries (4.22) (5.2)
- Labelling, quarantine and storage (4.24) (5.2)
- Sampling (4.25) (5.2)
- Testing (4.26)
- Release (4.27)
- Rejection (4.27)
- Distribution (4.28) (5.2)
- Validation and qualification (4.29)
- Equipment assembly (4.29)
- Calibration (4.29)
- Technology transfer (4.29)
- Maintenance (4.29)
- Cleaning (4.29)
- Sanitation (4.29)
- Personnel matters (4.29)
- Training (4.29)
- Clothing (4.29)
- Hygiene (4.29)
- Environmental monitoring (4.29)
- Pest control (4.29)
- Complaints (4.29) (8.5)
- Recalls (4.29) (8.20)
- Returns (4.29)
- Change control (4.29)
- Investigations (4.29)
- Audits (4.29)
- Product quality review (4.29)
- Supplier audits (4.29)
- Major items of manufacturing and test equipment (4.30)
- Master list of documents (4.32)
- Dispensing (5.2)
- Processing (5.2)
- Packaging (5.2)
- Reference samples (6.2)
- Correct labelling of containers of materials and products (6.2)
- Monitoring of stability (6.2)
- Investigation of complaints (6.2)
- In-process control (6.18)
- Investigations (8.8)
This list does not cover any procedures specified in the Annexes. Some procedures are requested more than once. My apologies if I have missed any – the list may not be totally complete! Please feel free to add any missing or make a comment.
THIS ARTICLE WAS ORIGINALLY PUBLISHED IN 2012 BUT HAS BEEN REVISED AND UPDATED IN NOVEMBER 2022
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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In the pharma industry all procedures must be documented. If you have an SOP only it is not enough, it must be operable. If you do not document all steps, operations, etc. your company does not work according GMP rules.
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