Article archive

How does the EDQM process CEP Applications? A new Policy provides Information

10/04/2014 18:17
In most cases, the processing of a new application for a Certificate of Suitability (CEP) or an application for the revision of an existing CEP by the EDQM is a multi-stage process and the Authority has to require further information from the API manufacturer in order to make an appropriate...

CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports: new FDA Guidance

09/04/2014 18:48
The US Food and Drug Administration (FDA) has published a new guidance on post-approval changes called "CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports". The aim of the document is to clarify which changes need to be reported in annual reports by sponsors of new and...

WHO published revised draft on the Guideline on "Hold Time" studies

09/04/2014 18:44
The key message of the Guideline has remained unchanged: manufacture in compliance with GMP requires the definition of hold times for intermediates and bulk products. The scope stated is the manufacture of solid dosage forms but it can also be applied to liquids and semi-solid dosage forms....

EDQM Database on Counterfeit/ Falsified Medicinal Products

09/04/2014 18:42
On 24 March 2014, the EDQM (European Directorate for the Quality of Medicines and HealthCare) launched a new database which should assist authorities in the fight against counterfeit/falsified medicinal products.  The database called "Know-X" will collect reports on counterfeit/falsified...

Question & Answer Document on GDP by European Commission

02/04/2014 18:52
On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpretation of the new EU GDP Guideline. The document contains 25 questions and answers. Some of the questions are simply for...

Balances - Correction of the Requirements in the U.S. Pharmacopoeia (USP)

02/04/2014 17:20
In the Pharmacopoeial Forum 40(1) a short-term revision of the General Chapter <41> with regard to balances was announced as "interim revision announcement".    Questions that arrived at the USP indicate that there is a potential problem with the requirement of...

New Process Validation Guideline by EMA

23/03/2014 21:51
After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in...

2010-2011 GCP inspection metrics report published by MHRA

18/03/2014 22:31
A report covering the period 1 April  2010 to 31 March 2011 has been added to the good clinical practice section. GCP inspections metrics report (223Kb)    

FDA Secure Supply Chain Pilot Program: 13 companies prequalified

05/03/2014 22:22
In August 2013, the U.S. Food and Drug Administration (FDA) initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs. The goal was to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products...

Japanese Pharmacopoeia and Japanese GMP Regulations- online

05/03/2014 22:06
On Japan's Pharmaceuticals and Medical Devices Agency (PMDA) website, you can find in the section "Regulations and Procedures" under the heading "GMP" requirements regarding the inspection of manufacturers of medicinal products and APIs who want to introduce their products into Japan.  Now, a...
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