In detail
Legal basis
The key reference is the European Commission's Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01). They are based on Article 84 and Article 85b(3) of Directive 2001/83/EC and replace the versions of 1994 and March 2013. In Germany, anyone engaged in the wholesale distribution of medicinal products needs an authorisation under Section 52a of the German Medicinal Products Act (AMG). Section 1a of the German Ordinance on Wholesale Trade in Medicinal Products (AM-HandelsV) requires companies to comply with the EU guidelines and to operate a functioning quality assurance system.
Who GDP applies to
GDP is aimed primarily at wholesale distributors. However, the guidelines make clear that a manufacturing authorisation includes authorisation to distribute the medicinal products it covers. Manufacturers distributing their own products must therefore also comply with GDP. Brokers, who do not physically handle the goods, are subject to the specific provisions in Chapter 10.
Core requirements
- Responsible person: the wholesale distributor designates a responsible person who fulfils their duties personally and is continuously contactable. They may delegate duties but not responsibilities. Under Section 2 AM-HandelsV, one must be appointed for each site.
- Storage: before a storage area is used, an initial temperature mapping exercise is carried out under representative conditions. Monitoring devices are placed where fluctuations are most extreme. Stock is rotated on the first expiry, first out (FEFO) principle.
- Suppliers and customers: medicinal products may only be obtained from holders of a wholesale distribution or manufacturing authorisation and only supplied to entitled recipients. Suppliers are qualified before the first purchase and periodically rechecked.
- Transport: the supplying distributor must be able to demonstrate that the goods have not been exposed to conditions that compromise their quality. Temperature-sensitive products require qualified thermal packaging, containers or vehicles.
Falsified medicines, recalls and self-inspections
Products identified as falsified or suspected to be falsified must be reported immediately to the competent authority and the marketing authorisation holder and physically segregated. The effectiveness of recall arrangements is evaluated at least annually. A self-inspection programme should cover all aspects of GDP. External audits may complement it but cannot replace it.
In practice at A&O Pharma
A&O Pharma supports companies with GxP audits and in preparing for regulatory inspections, including questions of storage and distribution. When we carry out secondary packaging and labelling of investigational medicinal products, we supply the clinical trial sites according to our clients' specifications.
GMP & GxP Consulting & QA SupportFrequently asked questions
Do manufacturers also need to comply with GDP?
Yes, where they distribute their own products. The EU GDP Guidelines state that a manufacturing authorisation includes authorisation to distribute the products it covers, and manufacturers doing so must comply with GDP.
Who is the responsible person under GDP?
The person designated by the wholesale distributor who is responsible for the quality system and GDP compliance. They fulfil their duties personally, must be continuously contactable and may delegate duties but not responsibilities.
Is temperature mapping of a warehouse mandatory?
The guidelines require an initial temperature mapping exercise under representative conditions before a storage area is used. It is repeated based on a risk assessment or after significant changes to the facility or temperature control equipment.
