The QP Declaration: some Questions remain open

Marketing authorisations require a QP declaration (issued by the Qualified Person) to confirm that the active substance (active pharmaceutical ingredient - API) has been manufactured in accordance with the EU-GMP Guide, Part II: Basic Requirements for Active Substances used as Starting Materials. This QP declaration is required from each registered EEA Manufacturer and Importer Authorisation Holder (MIAH) that uses the API as a starting material and/or is responsible for QP certification of the finished batch of a human or veterinary medicinal product.

The QP declaration template provides, in a format considered suitable for submission, a basis for demonstrating compliance of the active substance manufacture with GMP requirements and that the manufacturer has relevant knowledge of the supply chain.

However, more than one year after the final guidance was published, some questions remain open or are frequently asked by the stakeholders. The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has now published an updated document in October 2015 to summarise the most frequent questions and answers.

Amongst others, the following questions are answered:

• Must the QP declaration consider only the final active substance manufacturer site and its intermediate, or does it need to consider the manufacturing sites of the raw-materials used for the first synthesis step?
• When the only change in an updated CEP is the name of the HOLDER (the manufacturing site remains the same) what is the rationale for requiring a new QP Declaration?
• When a new API manufacturing site is added in an updated CEP, is it necessary to present a QP Declaration for the already approved API manufacturers?

The answers and other Q&As can be found in the CMDh Q&As QP declaration document CMDh/340/2015 (October 2015).

The European Medicines Agency's (EMA) original Qualified Person (QP) declaration template and accompanying guidance, which intended to clarify the expecations, was already published in 2014.