The main differences between GDP and GMP: 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. GDP Chapter 1 – Quality Managementshutterstock_153244328 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. GDP Chapter 2 – Personnelshutterstock_158320142 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.shutterstock_72811132 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. GDP Chapter 4 – Documentation This chapter has less detail than GMP. shutterstock_154971701The 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). GDP Chapter 5 – Operationsshutterstock_144468457 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. GDP Chapter 9 – Transportationshutterstock_138179042 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). GDP Chapter 10 – Specific Provisions for Brokersshutterstock_63181399 This is also unique to GDP and covers the activity of buying and selling products without physically handling them.
Posted on: Thu, 13 Nov 2014 03:29:10 +0000
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