GMP NEWS 2022

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.

Both in the production of purified water and in the production of WFI with membrane technology, reverse osmosis plays an essential role as the main barrier to impurities of all kinds. For pharmaceutical use the systems including the RO modules should be hot sanitisable. Chemical sanitisation of RO modules is no longer considered state of the art. But how often should hot sanitisation be carried out?

Ozone is an effective means for sanitising PW, HPW and WFI systems. But how high should the concentration of ozone be so that the sanitisation effect is sufficient?

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Analytical Method Precision Comparisons—A Special Case" was published. It addresses a statistical strategy that has been proposed to compare method precision during the transfer of a validated analytical procedure.

Almost simultaneously with the EU Commission, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) also published the revised Annex 1. What is the background?

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.