FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.

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.


FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

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.


EU-GMP: New Annex 16 released

The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Read more about the envisaged changes.


Frequently Asked Question: How important is Accreditation for Supplier Audits

We regularly receive questions related to GMP compliance issues. One of the most asked question addresses the topic accreditation of bodies that perform Third Party Audits. Read more in the GMP News.


FDA publishes new GMP Guide for Cosmetic Products

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.


New WHO Initiative "Good Pharmacopoeial Practices"

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.


QbD and RTRT - New Question and Answers published by EMA

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.


WHO publishes Variations Guideline for Prequalified APIs and Medicinal Products

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.


Final Variations Guideline on Procedures Issues and Classification of Variations published

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.


US FDA does not need to issue Written Confirmations by 2 July 2013

In a Press Release the US FDA announced that the U.S. is now a "listed" country" with the European Commission (EC). Read more.


Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA

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.


USP expert answers questions regarding particulate matter testing

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.


Guideline on the European Drug Master File Procedure updated

The EMA Guideline on the European Drug Master File (ASMF) Procedure was updated again. Learn more about the new requirements API manufacturers and applicants will be facing.


Written Confirmation: Japan on the List of "Third Countries"

Japan is the next API exporting country on the list of countries which don't need to issue "written confirmations". Read more here.


Answers by EMA on the Topic Bioburden

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.


WHO Guideline on Quality Risk Management finalised

With the new Technical Report (TRS 981) the WHO has published a comprehensive paper on the development of a QRM system. Read more.


MHRA implements new Software for risk based Inspection Planning

Medicines regulator implements innovative software to analyse risk data and target inspection activity. Read more.


GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

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.


USP defers the Implementation of General Chapters <232> and <233> on Elemental Impurities

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.


ACAA with Israel: what the QP needs to know

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.


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