The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).
The current GDP guidelines can be found here GDP Guidelines if you would like a copy. The obvious difference between GDP and GMP is that GDP covers the wholesale distribution of medicines, whereas GMP covers their manufacture. There is overlap between the two – to maintain product quality after a batch has been released from the manufacturing site, as well as to monitor and control complaints, problems and to permit a recall.
It may initially appear that GDP is smaller and less detailed than GMP, but this is not the case. If you compare the amount of coverage that GMP gives to its warehouse related activities then there is much less detail in GMP than can be found in GDP.
As with recent updates to GMP there are requirements in GDP for Senior Management. These not only include the requirements to provide sufficient competent personnel and suitable premises and equipment, but also to conduct Management Review meetings. These meetings are also now a requirement of GMP too, but GDP gives much more detail about what should be discussed at such meetings (clause 1.4) *.
* ICH Q10 (now Part 3 of EU GMP) does provide further guidance here for sites working to GMP.
The main difference here concerns the Responsible Person (RP), as opposed to the Qualified Person (QP) in GMP. The role of the RP is defined at clause 2.2. Unlike the QP, the RP does not to have to “certify the release” of specific batches, but they do need to be continuously contactable and have a good understanding of what is going on at the site working to GDP.
GDP Chapter 3 – Premises and Equipment
There are a lot of similarities here with GMP, however GDP does give additional requirements for the increased control of “special” types of medicinal products (such as Narcotics (with their black-market value) and Radioactive materials). There is also a requirement to have an intruder alarm system.
One of the main difference is the specific requirement to thermally map storage areas (clause 3.2.1). Whilst this is often done at warehouses working to GMP this is not a specific requirement of GMP. It is a requirement of GDP.
Both GDP and GMP require measuring equipment to be calibrated. GMP has no real detail on the mechanisms for calibration of equipment, whereas GDP provides much more detail, such as calibration equipment being traceable to recognised standards (clause 3.3).
GDP Chapter 4 – Documentation
This chapter has less detail than GMP. The main reason for this is that GDP does not require guidance on all of the manufacturing and testing related documents and records required by GMP. However the general “Good Documentation Practice” elements remain roughly the same. One noticeable exception is with regard to using a pen to complete records – GDP does not specify the need for entries to be indelible, where as GMP does. There is also more detail in GDP concerning the storage of personnel data (clause 4.2).
In many ways this chapter is GDP’s equivalent to GMP’s chapter on Production. There are many references in GDP to be vigilant for spotting falsified medicines in this and other chapters. GDP gives much more detail than GMP on the approval of suppliers and customers (clauses 5.2 and 5.3). These requirements mainly cover ensuring that materials are kept within the approved supply chain.
There is also more detail in GDP over the picking, supply and export of stock (clauses 5.7 to 5.9).
GDP Chapter 6 – Complaints, returns, suspected falsified medicinal products and recalls
Whilst there are many similar requirements to GMP there is more detail in GDP over the control of returned medicinal products (clause 6.3).
GDP Chapter 7 – Outsourced Activities
This chapter is similar to the requirements of GMP.
GDP Chapter 8 – Self-Inspections
This chapter is similar to the requirements of GMP.
This is unique to GDP and practically none of these requirements are covered in GMP. This chapter has requirements that include care of the product during transport, control of temperature, risk assessments of transport routes and control over the vehicles used. There are also specific requirements for the use of transport containers (clause 9.3) and control over cold chain transportation (clause 9.4).
This is also unique to GDP and covers the activity of buying and selling products without physically handling them.
I hope that you find this post useful. We are now offering a range of GDP training courses to Management, Responsible Persons and Warehouse Personnel – all presented in our highly interactive style. If you need any help in this area – please get in touch. You can email us at email@example.com for further details.
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 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.
Training courses on Annex 1
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