The Basics of Good Distribution Practice (GDP)

Good Distribution Practice (GDP) governs the potentially highly complex process of transporting drugs from where they were made to the patient – from just down the street to the other side of the world. What may leave the manufacturer and packager in perfect condition could still reach the patient in an ineffective or even dangerous state.

GDP rules affect pharmacists locally delivering drugs by van right up to the largest logistics firms and airlines. Most countries have their own legislation but the following five basic rules are the same throughout the world:

An appropriate Quality Management System (QMS) must be in place, with written procedures and clear records Products must only be supplied through authorised and legal channels Staff, premises and equipment must be appropriate to the activities being performed An individual must be nominated to take personal responsibility for the quality system There must be an emergency plan in case product needs to be recalled from the market. 1. The QMS… One of the key elements of any QMS is written documentation that sets out how processes and procedures are to happen. These can be in paper or electronic form but must be accessible to those who need to use them and they should be part of a document control system, which ensures they remain up to date and accurate.

2. The supply chain… Good, documented knowledge of the supply chain is essential in checking that the right procedures have been followed through as well as assisting any possible product recalls. However, strong supply chain management has another important goal - helping prevent counterfeiting.

There are a host of techniques that can be used to try and detect counterfeit drugs but in the face of an increasingly sophisticated billion dollar industry sometimes the safest measures are strictly controlling who you sell to and buy from.

3. Appropriate resources… Clearly the precautions that need to be taken to ensure a product retains its efficacy and integrity vary greatly between products. Key factors like temperature, humidity and even exposure to light may need to be monitored and controlled throughout the entire distribution chain.

Storage premises should be protected from unauthorised access. Testing performed during drug development will have identified acceptable conditions for storage, so these conditions need to be maintained. It is important to maintain storage within a tight range of temperatures as products can be denatured by cold as well as heat.

All staff involved in the distribution chain must be adequately trained, depending on their role. A good grounding in the aims, objectives and techniques of GDP is useful but can be challenging to deliver with staff spread between locations. Online GDP training, such as offered by Whitehall Training, is a useful way to achieve this without the expense of gathering learners in one location.

4. The nominated individual… In Europe, this is known as the "Responsible Person" (RP) and their role is to ensure that the conditions of the wholesale dealer’s licence are being met and that GDP is being followed. This will involve regular review and monitoring of all areas and activities. If any review activities are delegated, the RP must still be shown to personally perform the delegated tasks at least once a year.

5. Emergency recall… People responsible for executing and co-ordinating a recall should be clearly identified. The procedure should also require periodic mock recalls (at least annually) as practice and to evaluate readiness and effectiveness.

It is vital for the distributor to be able to identify and notify customers who will have received the affected product. This depends on accurate records, right down to the exact batch numbers and quantities supplied.

Of course, the path from factory to pharmacist rarely involves one company so each stage needs documentation and control – each may need its own nominated person, QMS and paper trail.

GDP is a sophisticated and evolving process. New formulations and anti-counterfeiting measures come on the market all the time. Sometimes there is even a discovery that has a massive potential impact on GDP – for example, research published earlier this month showed that at least some vaccines could still be effective when exposed to temperatures as high as 37°C!

GDP is a massive logistical challenge and takes place almost entirely behind the scenes – but without it there would be no way to get safe and effective treatments to those that need them, wherever they are.

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The Basics of Good Distribution Practice (GDP)

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