85 Company listed with GMP-Non Compliance Statements in the New EMA Database
As already reported, the EMA has started listing so-called GMP Non Compliance Statements in the EudraGMDP database in addition to Certificates of GMP Compliance. Now, detailed information has been made publicly available. Read more in the News.
FDA plans significant increase of GMP Inspections in China
For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Based on a new agreement with China, the US FDA will now increase the number of inspections significantly. Read more.
Because of ongoing globalisation and outsourcing activities, more and more audits have to be performed. A possibility in saving resources is sharing an audit. Read more about a service offered by the European QP Association.
FDA publishes List of GMP facilities producing for the US market (generic drug products and APIs)
The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms, APIs under the Generic Drug User Fee Act. Please read more about this list.
A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant. More information is available in this News.
New FDA Regulation gives the Agency more Power during an Inspection
FDA is proposing a regulation to implement administrative detention authority during inspections, which might present a new risk to facilities. Read more.
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.
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.
The heads of the EU authorities for medicines are organised in a group called Heads of Medicines Agencies. In a meeting which took place in Dublin just recently, the Committee identified the need for GMP inspections to be conducted at API manufacturing sites by the 2nd of July 2013. Read more.