Regulatory and Industry News...


FDA News
FDA have replaced the now defunct "cGMP Notes" with a new web page "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs."
They intend to use this format to provide timely answers to questions about the meaning and application of cGMPs for human, animal, and biological drugs.
These questions and answers generally clarify statements of existing requirements or policy, and as such, are considered Level 2 guidance. This resource is being co-sponsored by CDER, CVM, CBER, and ORA.
Access the Question and Answer page

Canadian healthcare company cited for inadequate laboratory instrument calibration program and inadequate stability program in FDA Warning Letter. read the Warning Letter

What happens if FDA decides that you aren't applying cGMP: US Marshalls seize GSK products Praxil CR and Avandamet. (Mar 2005)
read the FDA News release

FDA Warning Letter to Chiron Corporation regarding Influenza Virus Vaccine
read the Warning Letter

Draft revised Guidance to Industry.ANDAs: Impurities in Drug Products (Jan 2005)
Draft Guidance

Final report on the FDA's Pharmaceutical Analytical Technology (PAT) initiative.
PAT report

Draft Guidance to Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.
Incorporates the six-element "Sytems-based inspection model and a number of concepts found in the EU regulations and in ISO9001:2000, for example, self inspection.
Draft Guidance




European News
30 October 2005 Active Pharmaceutical Ingredients Annex 18 (ICH Q7A) goes from voluntary to mandatory status.
As of 30 October 2005, holders of manufacturing authorisations in the European Union can only use active substances that have been manufactured in accordance with Good Manufacturing Practice for starting materials. Member States have agreed that the ICH Q7A document "Good Manufacturing Practice for Active Pharmaceutical Ingredients", previously incorporated into Volume 4 of "The rules governing medicinal products in the European Union" as Annex 18 of the Guide to Good Manufacturing Practice" (Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 in the United Kingdom), should now form the basis of Part II of the main Guideline.

This brings the manufacture of APIs firmly into the regulatory framework of the pharmaceutical industry. Whereas in the past the regulator has expected that active substances were manufactured according to the principles of GMP, this is now a requirement, and there is an obligation on the part of the manufacturer of the medicinal product to ensure, by regular audit, that suppliers are fully compliant with GMP requirements. Inspectors will be able to ask to see audit reports.

To quote from the EMEA
"It is expected that the holder of the manufacturing authorisation will base such a declaration [ of compliance with GMP by the API manufacturer] on carrying out, or having carried out on his behalf, an audit of the manufacturers/distributors of the active substances concerned. . Examination, by inspectors, of the audit programmes used by authorisation holders for conducting regular audits (every 2 – 3 years), including review of audit reports, is one of the primary means by which Competent Authorities will determine if manufacturing authorisation holders are in compliance with the above articles."

See full text of EMEA Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials

See Part II of the GMP Guide

See new Introduction to GMP Guide


Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products CHMP/QWP/49313/2005corr released for consultation. Comments to EMEA by 30 July 2005.
Read the Guideline

Chiron manufacturing licence supspension lifted (Mar 2005) MHRA Press release

European Directive 2004/27/EC requires holders of Manufacturing Authorisations to use only Active Pharmaceutical Ingredients that have been manufactured according to pharmaceutical GMPs.
Read the Directive

European regulators start to get to grips with Good Manufacturing Practices for excipients.
Call for industry opinion