Good Distribution Practice: Guidance and legislation

Responsible Person (RP)
Regulation 45 of the Human Medicines Regulations 2012 state the requirement for a Responsible Person (RP) within the UK.

The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:

• to ensure that the provisions of the licence are observed
• to ensure that the operations do not compromise the quality of medicines
• to ensure that an adequate quality system is established and maintained
• to oversee audit of the quality system and to carry out independent audits
• to ensure that adequate records are maintained
• to ensure that all personnel are trained
• to ensure full and prompt cooperation with product licence holders in the event of recalls.

In order to carry out his duties, the RP should have a clear reporting line to the licence holder or MD. The RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas, etc. and the standards achieved.

Further information on the appointment and duties of the RP is available from:

Rules and Guidance for Pharmaceutical Distributors 2007

Guidance in the transportation of medicinal products - added 20 December 2011
The presentation below provides guidance on the ambient and refrigerated transportation of medicinal products and was originally presented at the PIC/S GDP Expert Circle held in Finland in October 2011, and attended by international pharmaceutical inspection authorities.

Guidance in the Transportation of Medicinal Products, ambient and refrigerated (273Kb)

For information, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which together provide an active and constructive cooperation in the field of GMP/GDP. PIC/S' mission is 'to lead the international development, implementation and maintenance of harmonised GMP/GDP standards and quality systems of inspectorates in the field of medicinal products'. This is to be achieved by developing and promoting harmonised GMP/GDP standards and guidance documents, training competent authorities, in particular inspectors, assessing (and reassessing) inspectorates, and facilitating the cooperation and networking for competent authorities and international organisations. There are currently 40 participating authorities in PIC/S (convention and scheme taken together). 

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S)

Updated Policy on returns of non-defective refrigerated (2 - 8c) medicinal products - added 23 April 2010
The Good Distribution Practice (GDP) Inspectorate has issued the following updated policy relating to returns of non-defective refrigerated (2 - 8c) medicinal products, which supersedes any previous policy published.

Returns of non-defective refrigerated (2c – 8c) medicinal products (8Kb)

Updated policy on returns of non-defective medicinal products - added 1 December 2009
The Good Distribution Practice (GDP) Inspectorate has issued the following updated policy relating to returns of non-defective medicinal products, which supersedes the previous policy published in MAIL 137 in 2003.
Returns of non-defective medicinal products (11Kb)

Cold chain distribution
Control of storage and transportation temperatures is essential in maintaining the quality of medicines and in helping to protect patients from sub-standard or ineffective medicines that may result from inadequate control.

Guidance on the regulatory requirements and points to consider when developing a distribution strategy can be found in Guidance Note 6 (11Kb) and in the attached presentation.
Cold chain presentation from the GDP symposium, January 2008 (84Kb)

Guidance on preventing breaches in the cold chain for medicinal products
The attached article provides guidance on the distribution and storage of refrigerated medicines, and is taken from an article originally written for and published in The Pharmaceutical Journal Volume 281 dated 18 October 2008.
Refrigerated medicinal products: what pharmacists need to know (103Kb)

Anti-counterfeiting strategy The MHRA's Enforcement Group are responsible for the UK anti-counterfeiting strategy. The strategy describes the MHRA approach to combating the availability of counterfeit medicines and devices in the UK. Further information relating to counterfeit medicines and the anti-counterfeiting strategy is available in the Counterfeit medicines and devices section.

Standard Operating Procedures (October 2012)
The guidance below highlights the value of standard operating procedures (SOPs) and provides basic guidance on how to write them.
Guidance on writing SOPs (27Kb)