Inspection of biotechnological Manufacturers - PIC/S AiM Updated

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

Although many things in the pharmaceutical environment are regulated by a large number of guidelines, there is still room for interpretation of the stipulations made in them. Often, guidelines only provide a framework within which one can move or define a final goal to be achieved or adhered to. This can lead to different interpretations of how measures need to be implemented to achieve certain goals or to comply with a certain condition.

In such cases, additional documents that provide interpretative guidance, e.g. Aide Mémoires (AiM) from inspecting authorities or higher-level institutions, can be very useful. In the EU, these can be national documents, such as those of the Central Authority of the Länder for Health Protection of Medicinal Products and Medical Devices (ZLG) in Germany, or international organisations such as the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S).

PIC/S has now updated an Aide Mémoire on inspections of biotech manufacturers in January. The aim of this AiM is to harmonise GMP inspections in biotechnological and biological facilities and to ensure their quality. Especially in federal systems, there is otherwise a risk of widely divergent procedures in official inspections. At the same time, an optimised use of inspection time can be achieved and a uniform assessment by the inspectors can be reached.

The guideline defines the validity as follows:

• The guideline applies to biotech products and classical biological products for human use, but could also apply to gene therapy and cell therapy products. It also includes products for use in clinical trials.
• The AiM should be considered as a non-exhaustive list of areas to be considered in an inspection.
• At the time of publication, this document reflects the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence.

However, it must always be considered in conjunction with other PIC/S documents, e.g. the general GMP principles and requirements for aseptic manufacturing (Annex 1) or the specific requirements for blood and plasma products of Annex 14.

For more details, please read directly in the revised Aide Mémoire "INSPECTION OF BIOTECHNOLOGY MANUFACTURES".