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

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