Quality Systems

In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.

Recent recalls have contributed to the pharmaceutical industry?s heightened awareness of glass delamination (i.e., the formation of glass flakes in a vial), which could affect drug quality and patient safety. To confront this growing problem effectively, drugmakers must understand its causes.

FDA, CMS, Medicaid Launch Pilot Program to Conduct Parallel Reviews of Medical Devices.

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.

Europe establishes new collaborative system to track products.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.

Drugmakers and packagers are pursuing various initiatives to reduce their carbon footprints. This article contains bonus material.

Getting the most value out of M&As requires proper upfront legwork.

Corporate management must be held accountable for quality at all levels.

Expanding the organization's mandate will strengthen inspections.

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

The authors summarize a recent FDA–PQRI workshop on process drift.

A Q&A with Rao Tatapudy, vice-president of scientific affairs at Catalent, on recent industry trends.

Letting contamination build up can cause multiple headaches.

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

In an effort to balance bilateral trade, India is urging China to increase Indian pharmaceutical imports.

Manufacturers fund research and reduce prices to tackle diseases.

Despite new hurdles, industry must move forward and fulfill its mission.

This risk-management case study focuses on assessing empty capsules.

FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.