GMP News - Pharmaceutical Technology

During an inspection carried out in October 2022, the FDA found unsanitary and dirty conditions at a sterile manufacturer in India, resulting in a Warning Letter.

The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

The delta ferrite content indicates the proportion of magnetisable, body-centred structure of the iron atoms in the stainless steel. It has an influence on the material properties of the stainless steel, primarily on its corrosion resistance. But how should the content be specified in stainless steel for pharmaceutical equipment or welding seams?

In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).