Quality Systems

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?

Shared audits of suppliers offer several advantages, but networking to conduct such an audit can be challenging.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

More acquisitions are expected as the patent cliff pushes the pharma industry into a critical phase, with many executives believing that the industry will be unable to innovate sufficiently from within to replace blockbuster drugs.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

The US Food and Drug Administration launched a program last week designed to "educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful."

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Sundlof Resigns as FDA's Head of Food Safety; and More

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The European Ombudsman has recommended that the European Medicines Agency review its refusal to grant public access to reports on adverse drug reactions.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.

A method for determining sample size is finally getting some respect.

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

The author outlines the key concepts of ISPE's recently revised Baseline Pharmaceutical Guide for New and Renovated Facilities. This article is part of a special supplement on Excipients and Solid Dosage.

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Though many advantages are associated with the European Clinical Trials Directive, complexities have emerged since its introduction in 2004. Since 2007, efforts have been made to raise the issues and address the negative impact of the Directive.

Though the pharma industry has improved its change management processes, there are still opportunities for improvement.

The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.