Last week’s round -up;
16 -20 November 2020

published 23 Nov 2020

Impact of GMP Annex 1 on Isolator Design and Cleaning

PharmTech has published an article on the impact of the EU good manufacturing practice (GMP) Annex 1 “Manufacture of Sterile Medicinal Products” guidance on aseptic operation and cleaning in the pharmaceutical industry. The article focuses on barrier systems including restricted access barrier systems (RABS) and isolators, and includes information on isolator design and cleaning validation.

Erratum concerning the Danaparoid sodium (2090) revised monograph

The EDQM has released an Erratum for the English version of the Danaparoid sodium (2090) revised monograph that was published in Ph. Eur. Supplement 10.3 with an implementation date of 1st January 2021. The Erratum concerns the erroneous deletion of the time from the addition of the chromogenic substrate after which the first measurement of the absorbance in the anti-factor IIa activity test is to be performed. The corrected text of the English version of the monograph will be included in the print version of Ph. Eur. Supplement 10.5, however, the online and downloadable versions of the monograph have been corrected:

Nitrosamines recommendations alignment for sartans

The CHMP has aligned the recommendations for limiting nitrosamine impurities in sartan medicines with the recent recommendations for other classes of medicines. The limits for nitrosamine levels will now apply to the finished product, rather than to the active substance as in the previous recommendations. The limits are based on internationally agreed standards (ICH M7(R1)) and should ensure that the excess risk of cancer from these impurities in sartan medicines is below 1 in 100,000 for people taking the medicine for lifelong treatment. The newly aligned recommendations also require that companies have appropriate control strategies in place to prevent or limit the presence of nitrosamines as much as possible, improve their manufacturing processes when necessary, and conduct risk assessments for possible nitrosamine contamination in their medicines.

The Role of Integrity Testing in Laboratory Sterility Filtration

Sterility filtration is essential in research and pharmaceutical laboratories as many processes demand that the filtrate is free of biological contaminants to prevent downstream contamination, equipment failure and human health risks. Therefore, validation of the sterility performance of filters is required. Several factors may affect the performance of sterility filters, such as the handling of filters, particle load, pressure and temperature fluctuations, and chemical exposure. Integrity tests are used by manufacturers and users to confirm the structural soundness and performance of a sterility filter before and after use. The following PharmTech article reviews destructive and non-destructive integrity tests which are commonly used to validate sterility filter performance. The article delves into the different testing methodologies and why these are critical to ensure filter performance and reduce laboratory risks: