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 Management

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 – Personnel

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).

GDP Chapter 5 – Operations

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 – Transportation

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 Brokers

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 info@inspiredpharma.com for further details.

Regards, Dominic