Article archive

GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

15/08/2013 00:35
The European Medicines Agency EMA specifies in one of its questions and answers documents on the GMP guideline under the heading "EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances" its requirements for active substances....

Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

15/08/2013 00:29
The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and...

Canada: GMP Requirements now Applicable to all APIs

15/08/2013 00:23
 The GMP requirements which have been applicable to medicinal products in Canada have now been extended to APIs which are used in human and veterinary medicinal products. This information was published on 8 May 2013 in a press release of Health Canada. A modification of the Canadian GMP Guide...

FDA Two new Q&As published for Investigational Drugs

15/08/2013 00:20
The U.S. Food and Drug Administration FDA has published two new Question and Answer Documents on Investigational Drugs. One of the draft Guidance for Industry documents is intended to provide information for industry, researchers, and physicians about the implementation of FDA's regulation on...

MHRA CONCLUSION on New requirements for active substances imported into the European Economic Area

22/05/2013 23:08
The Falsified Medicines Directive 2011/62/EU ("the FMD") modifies EU Medicines Directive 2001/83/EC and from 2 July 2013 introduces new requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products. The FMD...

A Major Mistake That Managers Make

22/05/2013 22:14
A Major Mistake That Managers Make - Article by Russ Ackoff, Ph.D.

FDA addresses retention of Internal Audit Reports

22/05/2013 22:11
Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed? The CGMP regulations (21 CFR 210 and 211) for finished pharmaceutical manufacturing do not specifically address the requirement to conduct, or to keep records...

Ranbaxy pleads guilty and pays $500 million fine

22/05/2013 22:05
Indian generic drug-maker Ranbaxy Laboratories pleaded guilty May 13, 2013 to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. As part of the...

WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required

22/05/2013 21:41
The WHO has published a proposal for the revision of its supplementary guideline on GMP validation (Annex 7: non-sterile process validation). The document contains 11 pages divided in: 1. Background and scope 2. Glossary 3. Introduction 4. Phase I. Process design 5. Phase II. Qualification and...

EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

22/05/2013 21:33
On 26 April, the Committee for Medicinal Products for Human Use (CHMP) published the draft "Guideline on Similar Biological Medicinal Products" for public consultation until 31 October 2013. This guideline is supposed to replace the Guideline on similar biological medicinal products...
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