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Documents required by EU GMP

February 24, 2012

Dominic Parry

The following lists the specified documented procedures required by EU GMP.  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”.  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.

This list accounts for the recently updated version of EU GMP Chapter 4.

Site Master File (Chapter 4 Principle)

Product Specification Files (Chapter 4 Clause 2 (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)

Labelling, quarantine and storage (4.24)

Sampling (4.25)

Testing (4.26)

Release (4.27)

Rejection (4.27)

Distribution (4.28)

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)

Recalls (4.29)

Returns (4.29)

Change control (4.29)

Investigations (4.29)

Audits (4.29)

Product quality review (4.29)

Supplier audits (4.29)

Procedures for major items of manufacturing and test equipment (4.30)

Master list of documents (4.32)

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)

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.

3 Comments

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  1. February 24, 2012

    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.

  2. March 3, 2012

    It is really a great and helpful piece of info. I am satisfied that you just shared this useful info with us. Please stay us up to date like this. Thanks for sharing.

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