GMP New Aide memoire

Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) has published a new Aide memoire (AiM) for process validation. The AiM describes the expectations that GMP inspectors should place on the principles of validation and quality risk management to process validation following the revision 2015 of Annex 15 of the EU GMP guideline.

Based on a lifecycle model of production processes, in addition to the process-development - minimal versus extended (Quality by Design, QbD) approach - the permissible approaches to process validation are discussed. Three approaches of process validation, analogous to Annex 15, are open:

• Traditional approach'
• Continuous process verification (CPV)
• Hybrid from the two approaches

In a further chapter, accreditation versus GMP requirements for the process validation (from the quality manual to the validation master plan and SOP to the requirements of validation, sampling plan, etc.) are clarified.

The document focuses on the risk assessments required at all stages of the product lifecycle. Special attention is made to the principles of quality risk management (QRM). Critical quality attributes of the drug, critical process parameters and the quality of the raw material are taken into account, combining development and initial validation.

Finally, the AiM contains an excursus on QbD-based process control and control of design space, process-analytical technologies (PAT), statistical process control (SPC) and real-time release testing (RTRT).

Aide Memoire, AIM07122901