GMP News - Validation

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

As part of inspections the authorities also check computerised systems. Klaus Feuerhelm, former inspector at the Regierungspräsidium Tübingen, has created a TOP 3 list of the most frequent complaints for 2020. TOP 2 of the list - system descriptions. What were the deficiencies found here?

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the international association of pharmaceutical inspectors, published the long-awaited guidance document on data integrity on July 1, 2021. Read more about the contents of the document PI 041 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

The new version of APIC's document "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS" was finalised in February 2021 and is now available.

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.