EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations
The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.
More Flexibility in Sterility Testing of biologic Products – FDA Amendments
Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.
The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.
Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms
In the March Edition of the American Pharmaceutical Review, Dr Michael Miller published a case study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and provides an Estimation of Viable Cell Count. Read more.
FDA issues Amendment to the Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products
The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”. More details can be found here.
Recently, the USP published frequently asked questions relative to different General Chapters, amongst others to Chapter <62> Microbial Enumeration of Nonsterile Products: Tests for Specified Microorganisms. More details can be found here.
FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus
Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. Read more.
CVMP published the draft guideline "VICH GL34: Biologicals: testing for the detection of mycoplasma contamination". It is is intended to facilitate the harmonized licensing of new products for veterinary use. More details can be found here.