Qualified Person and Responsible Person Services for GMDP

The European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal Products for Human Use) requires that every batch of medicinal products must be released for sale or supply by a Qualified Person (QP), who certifies that the batch has been manufactured in accordance with the relevant requirements.

The Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use, 2013/C 343/01 require the appointment of a Responsible Person to ensure compliance with these guidelines.

Annette Callaghan Limited’s consultants have considerable experience in pharmaceutical manufacturing and distribution operations and are eligible to act as Qualified Persons under permanent provisions. This experience includes auditing of API manufacturers, medicinal product manufacturers, test laboratories and distribution facilities. We audit in the UK and around the world.

Post Brexit, UK manufacturers wishing to sell their medicinal products in the EU will be required to have these products tested and released in one of the EU-27 member states. Annette Callaghan (Ireland) Limited has been established to provide this service to you.

Annette Callaghan Limited is also partnered with a team of expert pharmaceutical consultants who can provide much needed support to enable dossier submission, regulatory approval and the successful release of marketed products around the world.

Our QPs and RPs are fully conversant with current GMDP requirements for APIs and medicinal products in regulated markets and have extensive experience in auditing suppliers to the pharmaceutical industry.