QP Audits for GMP Compliance.
Safeguard your products with comprehensive QP audits throughout their lifecycle.
Basis of QP Declaration:
- An important element in the approval of any medicinal product for the European market is the provision of a QP declaration, signed by a Qualified Person, confirming that the active substance used in the formulation of the medicinal product has been manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products for human and veterinary use.
- The QP declaration must be provided by each registered EEA Manufacturer and Importer Authorisation Holder (MIAH) that uses the active substance as a starting material and is responsible for certification of the finished batch of medicinal product.
- Where more than one MIAH is involved, a single declaration may be provided by one QP on behalf of all QPs involved in the supply chain and based on a quality technical agreement.
- An audit of the active substance manufacturer(s) must be performed and acts as the basis of the QP declaration. It is expected that the audit will be performed on the manufacturing site and provides sufficient detail on which the QP providing the QP declaration can confirm GMP compliance of the site.
- It is acceptable for Third Parties such as Arriello to be engaged for QP audit performance on behalf of the MIAH. Arriello have experienced QPs and Senior Auditors available to perform QP declaration audits on behalf of our clients, saving time and resources for this important activity.
What our clients say about us.
Bracco, Italy
After evaluating several vendors to help us set up and manage our global literature screening process, we chose Arriello due to their professionalism and thorough understanding of global requirements.
