22/23 May 2024
Each holder of a manufacturing authorisation for medicinal products in Europe needs to name at least one Qualified Person (QP). The legal basis for the appointment of a QP is defined in the DIRECTIVE 2001/83/ relating to human medicinal products (and in DIRECTIVE 2001/82/EC relating to veterinary medicinal products). These directives clearly determine the educational background and professional experience a professional requires to act as a QP as well as the duties and responsibilities associated with this function.
Batch Certification and Release are defined in Annex 16 of the EU Guide to GMP. It also covers those cases where a batch has had different stages of production or testing conducted at different locations or by different manufacturers. In this context, the QP must personally ensure that the responsibilities listed under Chapter 1.6 of Annex 16 are fulfilled. Chapter 1.7 lists many other responsibilities to be guaranteed by the QP. However, the related tasks can be delegated and the QP can rely on the respective quality management systems. Yet, the "QP should have on-going assurance that this reliance is well founded" (1.7). In consequence the central responsibility of a certifying QP is to hold back any certification of a batch until this assurance is achieved and all of the necessary tasks are reliably executed and completed.
Now, PIC/S* has adapted EU GMP Annex 16 ("Certification by a Qualified Person and Batch Release") and calls it "Certification by the Authorised Person and Batch Release".
So far, PIC/S had not adapted EU Annex 16. Originally, PIC/S considered that this Annex was too EU-specific and difficult to implement for PIC/S purposes. However, after a consultation of the participating PIC/S authorities in 2017, it was then decided to tackle an implementation of the Annex. The background was also the international harmonisation effort.
The Annex (together with a revised Annex 13 for investigational medicinal products) has now been adopted by the PIC/S Committee on 26 January 2022. The revised PIC/S GMP Guide (PE 009-16) with the revised Annex 13 and the new Annex 16 entered into force on 1 February 2022. All non-EEA/EU Participating Authorities of PIC/S and applicants have been invited to transpose Annexes 13 and 16 into their own GMP Guides. It will be interesting to see how these authorities (which include e.g. the US FDA) approach a possible implementation.
*The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).