13/14 December 2023
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* is planning to adapt EU GMP Annex 16 and will call it Authorised Person and Batch Release (however the PIC/S term of "Authorised Person" and the EU term of "Qualified Person" are strictly equivalent). Following the revision of EU Annex 16 in 2016, PIC/S discussed "whether to transpose Annex 16 in order to harmonise internationally requirements regarding product release in line with PIC/S' mission" and "to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products".
The PIC/S Committee has now started Step 2 of the PIC/S consultation/ adoption process. This Step 2 process enables PIC/S Participating Authorities to consult with stakeholders. This consultation phase was now launched for a period of three months.
It will be interesting to see how stakeholders especially from outside the EU will see this initiative.
Source: PIC/S News (June 2021)
*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).