Article archive

Updated Procedure for the Renewal and Revision of CEPs!

15/08/2013 01:38
After the latest updates in the categorisation of variations in authorisation procedures, the EDQM has now published the revised version of the document entitled "Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs". This Guideline...

New EMA Guideline on Starting Materials from Biological Medicinal Products

15/08/2013 01:32
Unlike recombinant products whose APIs are derived from a defined cell bank, so-called biological medicinal products are characterised by large variability in sourcing and intermediate steps. Biological medicinal products are derived from human or animal organs, tissues or body fluids. As a rule,...

Draft Guideline ICH Q3D for Elemental Impurities published!

15/08/2013 01:29
The long-awaited "Guideline for Elemental Impurities - Q3D" was published on ICH's website on 5 August 2013. According to the different steps of the ICH process it appeared as a Draft Consensus Guideline and is open for comments (deadline not yet specified). The document contains 9 chapters and 4...

Denying, Delaying, And Refusing: How to Fail a FDA Inspection

15/08/2013 01:26
The inspection of a facility by the FDA is based on certain rules and laws. During an on-site inspection, inspectors are entitled to request access to all documents and rooms connected to the manufacture of medicinal products and APIs for which a marketing authorisation application has been...

CDSCO publishes more than 200 Written Confirmations for APIs from India

15/08/2013 01:24
The "Central Drugs Standard Control Organization" of India's Ministry of Health and Family Welfare has published on its website a list of Written Confirmations for manufacturers who export APIs to the EU. The page lists the sites including postal address, the names of APIs manufactured at the site...

Variations: Important Changes in the New Application Form

15/08/2013 01:22
In May of this year, the EU Commission brought together in one document the two guidelines on the handling of variations procedures and categorisation of changes. Now, the application form for variation to a marketing authorisation has been updated too. A respective notification was released on 19...

New Requirements of the FDA on Stability Testing of Generic Drugs

15/08/2013 01:19
So far, those who have been applying by the FDA for the authorisation of a generic medicinal product for the American market could (with regard to the data for stability testing) refer to a communication from the FDA to the pharmaceutical industry from 1995. In this "Letter to Industry", the...

New EMA Inspection Requirements on Good Distribution Practices (GDP)

15/08/2013 01:17
On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Since July 2010, the document...

Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications

15/08/2013 01:08
The EU Commission has already created a Questions & Answers document addressing the most important questions with regard to the Written Confirmations for APIs imports from non-EU Countries. In practice though, problems keep on arising for which no satisfying answer can be found in this...

New FDA Guideline on Quality of Heparin

15/08/2013 01:06
In June 2013, the FDA published the final Guideline on "Crude Heparin" Quality. This guidance is intended to alert to the potential risk of crude (= unprocessed) heparin contamination. The tests listed in the guideline intend to help avoiding the use of oversulfated chondroitin sulfate (OSCS)....
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