Quality Systems

Do advanced therapies represent medical miracles or risky business? This is the question that is debated by an Informa analyst in an Executive Briefing for Scrip.

The US Pharmacopeial Convention posted a proposed revised standard for what should and should not appear on the ferrules and cap overseals of medication vials.

Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.

Representatives to the PIC/S provide an example of methodology for implementing ICH Q9.

Dumbed-down presentations and poor speaker selections are destroying a valuable industry tool.

With so many healthcare and pharmacy websites, consumers could use the agency's nod of support.

The authors discuss a study that demonstrates the use of polyethylene oxide mixtures to investigate the effect of polymer viscosity on formulation robustness.

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

Generic-drug manufacturers look to expand into biologics and complex dosage forms. This article contains bonus online-exclusive material.

The authors describe the development and organization of the Product Quality Research Institute and highlight some of the important projects conducted by its Working Groups.

The quality assurance environment is forcing pharmaceutical companies to face new challenges. In light of this, the authors conducted a study of professionals from some of the world's top pharmaceutical companies to identify key QA concerns.

Governments, regulators and international agencies continue to defend against counterfeiters; in particular, the European Commission has outlined measures that may help to better regulate pharmaceutical distributors.

Five per cent of consumers across five European countries suspect they may have received a counterfeit prescription and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).

The Society for Chemical Manufacturers and Affiliates (SOCMA) provided an update as to its grassroots efforts regarding the recently passed Chemical and Water Security Act of 2009 (HR 2868).

The US Food and Drug Administration has issued 22 Warning Letters to website operators as part of its International Internet Week of Action.

Five percent of consumers across five European countries suspect they may have received a counterfeit prescription, and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance.

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

On Sunday, Nov. 8, 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its disappointment with the US House of Representatives's healthcare-reform bill.

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

The heightened focus on risk raises concerns about delays in approving new drugs.