What’s new in the latest version?
The EU GMP Chapter 4 on Documentation came into force on 30th June 2011. Many of the updates were in-line with existing good practices. Some of the main changes are summarised below. You should refer to the actual document, Chapter 4 Documentation, for the full details.
In general, there is increased coverage of the use of computer systems
This reflects the increase in the use of computers, coverage in GMP has been poor historically and limited mainly to Annex 11.
For the first
time a Site Master File (SMF) is mentioned (see “Principle”)
This document described what goes on at your site and is submitted to the Regulatory Authority as part of the site approval process. It needs to be kept up-to-date.
For the first time, a Standard Operating Procedure (SOP) is mentioned (see “Principle”)
Most sites refer to their procedures as SOPs. Whilst procedures have always been described in GMP the term Standard Operating Procedure or SOP has never been used in GMP before now.
You now have to follow your documents! (see 4.1)
A strange omission in GMP, but you could argue that if you didn’t follow your procedures then chaos would soon follow. There was no mention before (in Chapter 4) of actually having to follow any of your procedures. If you looked hard enough however you could find the requirement to follow your procedures in Chapter 1 “the finished product is correctly processed and checked, according to the defined procedures” (see 1.1 vi) and Chapter 5 “all handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and, where necessary, recorded” (see 5.2).
Documentation in “house” format (see 4.4)
For the first time, there is the requirement for some form of standard format and layout for your procedures – “imperative mandatory style”.
More clarity on how long you keep records for (see 4.11)
Nothing new here for “normal” medicinal products, however, the previous version of Chapter 4 just stated records should be kept for “one year after the expiry of the batch”. Elsewhere in GMP it also stated “or at least five years after certification of the batch by the Qualified Person, whichever is the longer”. Here in the update they just bring the two sentences together.
What is new is further clarity on records associated with the manufacture of clinical trial materials (“at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used”).
Increased requirements for areas of policies, procedures and records (see 4.29)
Now we have the first mention in GMP of a “policy”. Most firms have lots of policies. There is also an enhanced list of activities that should be subject to policies, procedures and records. These include technology transfer, change control, investigations into deviations and non-conformances, internal audits, product quality review and supplier audits.
Master list of documents required (see 4.32)
Here for the first time, a formal list of documents is required – “an inventory of documents within the Quality Management System should be maintained”.
As stated earlier, many of these new additions are a reflection of existing best practice and are unlikely to cause you any problems. It will be a good idea to actually read the whole chapter however and do a check that you are actually meeting all of these new requirements.
I hope you found this article useful. Please feel free to make a comment if you like.
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It there a typo error on the date? Please check this out!
The EU GMP Chapter 4 on Documentation has recently been reviewed and updated, coming into force on 30th June 2011.
Do you mean 30th June 2012.
Hi – it did come into force on 30th June 2011. I have slightly reworded the text to clarify. Thanks for this. Dominic