News & Trends
Since the pilot program from January 01, 2001 to June 30, 2001 FDA is using more and more the Quality System Approach during its domestic and international inspections of drug products, API and device manufactures.
Investigators undertook a s
Dietary Supplement "Flexible" Testing Requirements Proposed In GMPs FDA's proposed good manufacturing practices for dietary supplements would require final product testing for adherence to identity, purity, quality, strength and composition specifications unless a scientifically valid analytical method does not exist.
'We would require that you test each finished batch of the dietary ingredient or dietary supplement produced before releasing for distribution to confirm that specifications are met' the proposed regulation states.
In the absence of a valid
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas. At a meeting June 14-15, 2007, the FDA and themore ...
The new ICH Guideline Q10 has combined different guides for Quality Systems into one document.
This guideline was developed based on the following documents to achieve a global harmonization for the requirements of a modern quality syst
Quality Systems Framework for GMP Inspectorates is part of the Compilation of Community Procedures on inspections and exchange of information and referred to in Directive 2003/94/EC Art.3.1. The Quality System Requirements make reference to auditsmore ...
The European Commission has published the revised Chapter 1 of the GMP Guide for review and commenting.
The European Commission posted this revision with the following introduction on their web page:
"Chapter 1 of the GMP G
A new European regulation on paediatric medicines will be entering into force on 26 January 2007, the implementation of which is a main priority for the European Medicines Agency (EMEA) in its work programme for 2007.more ...
Based on the EU Directive 2004/27/EC, amending directive 2001/83/EC, which requires for that all medicine APIs must be manufactured according to the GMP guidelines as defined by ICH-Q7A, Germany's health agency published the 14. AMG-Novelle (14thmore ...
New FOOD and DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL for Active Pharmaceutical Ingredient (API) process inspection
This revised program defines a systems approach; incorporates Q7a guidance; updates th
ingredient (API) or a finished drug product is released for distribution?
FDA has published a new statement and updated an existing one. The wording of the statement is as follows:
No. Neither the CGMP regulations nor FDA pol
Pharmaceutical CGMPs for the 21st Century - A Risk Based Approach - Final Report
LINK: CGMPs for the 21st Century - A Risk Based Approach
Recently FDA released a number of expected documents, some finalized and some as drafts.
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice
Associated Press 08.18.2004, 02:14 PM
Mylan Laboratories Inc. was dealt a setback by a federal judge who ruled that the Food and Drug Administration violated no law in rejecting the pharmaceutical giant's application for a pain medicati
Concept Heidelberg regularly splits FDA cGMP warning letter issues to their CFR reference and publishes statistics about most frequently found deviations. As in the past year, the list is headed by § 211.100, which refers to the creation, appmore ...
A new FDA draft guidance for dispute resolution allows the manufacturing site to challenge FDA inspection findings on the Form 483 10 days after the Form 483 was issued. The district office or applicable ORA office should respond in writing withinmore ...