EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture.
The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.
The objective of this guidance and the QP declaration template is to emphasize the importance of providing a valid declaration, to harmonize the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process, including the timely processing of relevant regulatory submissions. While not mandatory, applicants are strongly encouraged to use the template to facilitate the validation of regulatory submissions and their review.
The QP declaration should be provided in support of applications for marketing authorizations, variation or renewal of a medicinal product(s) authorized in the Community, using EU or national procedures within the scope of the respective Directives.
QP declarations are required from each EEA finished-product manufacturing site and/or from each site of importation/batch certification. A single declaration from one QP from one of the registered finished product or batch-release sites, however, may be sufficient, if its basis is satisfactorily described and supported by technical agreements between these sites.