ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).
Nitrosamines have already been detected in a large number of medicinal products. Where do they come from and how are they transferred to the final product? Read more here about the causes for nitrosamine impurities that have already been identified and what should absolutely be taken into account in the risk assessment of medicinal products.
Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here
The Ph. Eur. provided a sample monograph to clearly show which information is included in and how to work with a Ph. Eur. monograph.
MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import).
FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".
A set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).
The EMA has published three further statements on nitrosamine. Find out what marketing authorisation holders of drugs with chemically synthesised APIs ought to do regarding potential nitrosamine contamination.
The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.
The just published Version 16 of the Q&As on Safety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.