Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs
FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.
Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May
The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.
Harmonisation of the pharmacopoeial Texts for use in the ICH Regions on Micro Enumeration finalized
Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.
EDQM publishes Press Release on microbiological Control Symposium
Two weeks after their microbiology symposium in Strasbourg, the European Directory for the Quality of Medicines and HealthCare (EDQM) summarized the event in their press release entitled "Microbiological control symposium: consensus on readiness of new methods emerges".
New USP Chapters regarding Testing for Subvisible Particles
The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.
General requirements for Plastics in Pharmaceutical Engineering
The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?
Media Fill and Aseptic Behaviour in Focus of FDA Warning Letter
Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?