The US FDA has conducted retrospective analyses of data from a large health claims-related database as well as continued postmarketing adverse event reports of thrombosis. These analyses have strengthened the evidence for an association between the use of intravenous, subcutaneous, and intramuscular human immune globulin products and the risk of thrombosis. For that reason the authority now demands a boxed warning for the entire class of products. Read more.
Related to the HCT/Pdonor testing, the FDA/CBER has updated their page with licensed donor screening tests and further information about safety for relevant communicable disease agents and diseases. Read more.
A new WHO initiative is supposed to harmonise the pharmacopoeia standards, including the acceptance of the monographs between the single pharmacopoeias. To find out more about the WHO initiative "Good Pharmacopoeia Practices" please see the details.
The level of cooperation between inspectors and assessors when handling "QbD" applications involving RTRT (Real Time Release Testing) was added to the Q&A part of the EMA's website in June 2013. More information can be found in the News.
The new WHO Variations Guideline lays down the requirements for the variations categories and applications for the manufacture and examination of prequalified APIs and medicinal products. Read more about the new regulation.
The two guidelines on procedures and categories of variations have been recently combined in an updated document. More details about the "Variations Guideline" recently published on the Commission Website can be found here.
On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing. Read more here.
Scott Aldrich, member of the USP Dosage Forms Expert Committee, answered several very interesting questions regarding the USP chapters for testing of particulate matter during the ECA conference "Particles in Parenterals", 7-8 May 2013, Vienna. Please find the questions and answers here.
The questions "For an aseptically produced product, where should bioburden monitoring take place?" and "What is the maximum accepted bioburden level?" are answered by EMA on its questions and answers page. Read more.
EMA’s Inspectors Working Group defines concrete criteria for the quality standards of audit reports of active substances and for the qualification of auditors in its list of questions and answers updated recently. Get more detailed information on the criteria here.
The USP has deferred the date for the publication (1st May 2013) of the revised section 5.30.60 in the "General Notices" until further notice. This section would link the General Chapters on Metallic Impurities <232> and <233> to drug product monographs. Read more here about USP's reasons for that decision.
The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.