QP Certification is a mandatory legal requirement under EU and UK regulatory frameworks and a key element of global GMP compliance.
The QP ensures that every batch has been manufactured, tested, and stored in accordance with its Marketing authorization (for commercial products) or Clinical Trial Authorization (for investigational products), and that it meets all relevant GMP standards. Particularly in Europe and the UK, QP certification is required once a batch arrives from the manufacturing site and completes any local testing or labeling. It must occur before distribution to investigator sites or patients, following any post-manufacture operations such as labeling, blinding, or re-packaging, and in import/export situations where investigational medicinal products must be certified by a locally licensed QP before release for use in that region.
