News

A Contamination Control Strategy (CCS) in a company covers many areas. Some aspects, such as the classical topics from Annex 1, are quickly recognized as part of a CCS. However, other areas are also affected that do not immediately stand out when one looks only at the chapter headings of Annex 1. One such topic that we would like to briefly touch on today is the outsourcing of activities related to cleaning and disinfection.

With the publication of a revised Q&A guide, the FDA is responding to the recommendations on endotoxin testing set out in USP chapters <85> and <161> and in the AAMI guidelines for medical devices.

In December, the FDA published a Warning Letter to a manufacturer of OTC products, in which it identified deficiencies in both the handling of microbiological deviations and the validation of alternative rapid microbiological methods. The testing and analysis of raw materials used for contamination was also inadequate.

Due to high demand, the ECA has extended its special offer of sending two additional participants free of charge for each registered participant and a two-year membership for all congress participants and PharmaTechnica visitors until 31 January. After that, the 2-for-1 offer will apply until the congress.