GDP – Good Distribution Practice.

27th October 2015

There are few industries as regulated as pharmaceuticals and medical devices – and maintaining quality standards throughout the supply chain is absolutely vital.

Just as there are clear best practice guidelines when it comes to the manufacture of products (Good Manufacturing Practice), the same applies to distribution. It’s what’s known as Good Distribution Practice, or GDP, and new MHRA guidelines released in 2015 place significant new demands on both manufacturers and distributors.

This month, we explain what Good Distribution practice is, what the newest set of guidelines say, and how you can ensure that you’re in full compliance and doing things in the right way.

What is Good Distribution Practice?

Good Manufacturing Practice guidelines require all pharmaceutical products to be manufactured according to strict principles, designed to maintain consistent quality and safety standards.

Good Distribution Practice is an extension of this, and aims to ensure that this level of quality and consistency extends throughout the distribution chain. It provides a framework, setting out clear guidelines to ensure that all products are:

Obtained from the licensed supply chain
Stored correctly
Consistently transported and handled under suitable conditions

This helps to ensure that all pharmaceutical products and medical devices reach the customer/patient in the correct condition.

The first edition of GMP guidelines, “Guide to Good Pharmaceutical Manufacturing Practice” was published in 1971, and it has been updated regularly since then. Distribution was first covered in the 5th edition, “Rules and Guidance for Pharmaceutical Manufactures and Distributors”, which was published in 1997.

The latest (9th) edition was published in 2015, and sets out regulations covering best practice distribution and supply chain procedures relating to:

Personnel
Premises & equipment
Deliveries to customers
Returns
Self inspections
Provision of information to Member States in relation to wholesale activities

Who do the guidelines affect?

Article 1(17) of Directive 2001/83/EC defines distribution as:

“…all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public.”

It’s also important to remember that any person engaging in the activity of a wholesale distributor has to be the holder of a wholesale distribution authorisation.

So do the GDP guidelines affect your business? If your business operates in the European pharmaceutical industry, or supplies to businesses working in the European pharmaceutical industry – then the simple answer is yes!

In the UK, the MHRA carries out inspections to ensure that every business complies with GDP guidelines, at the time you apply for your wholesaler licence, and periodically thereafter. Your sites overseas may also be inspected.

Failure to comply with the GDP guidelines can have extremely serious consequences for any business, including regulatory action, and the suspension/revocation of licenses.

Understanding the new GDP guidelines

The most recent set of GDP guidelines are covered by the EU Guidance on Wholesale Distribution Practice (2013/c 343/01). Published in 2013, these regulations place significant new demands on the manufacturers and distributors of pharmaceutical products.

This in response to the challenges presented by new technological developments and increasing globalisation, and covers a range of activities, including:

Change control
Corrective and preventative action (CAPA)
Quality risk management
Outsourcing
Falsified medicine
Changed requirements for the responsible person
Management responsibilities
Transportation
Brokers

The new framework illustrates and recognises the complexity and intricacies of the modern distribution process, which often involves multiple procedures and parties in different locations worldwide. It aims to minimise the risk of potential fragilities across the distribution chain that could cause harm to patients.

The implications of these new guidelines for businesses operating in the pharmaceutical industry are huge, and it’s absolutely vital for every business to have a full understanding of the new regulations, and any areas where they fall short.

How Lime Associates can help

At Lime Associates, we’re dedicated to helping businesses to understand and implement the new GDP guidelines.

Our team of consultants have a comprehensive understanding of the new regulations, and extensive hands on experience in helping pharmaceutical businesses to adapt their practices to meet the requirements of the new regulations.

For further information on how Lime Associates can help your business to optimise its distribution and supply chain, contact an expert member of our team today on +44 (0) 114 213 8306, or email enquiries@lime-associates.com.