Quality Systems

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.

FDA Makes Organizational Changes Within CDER.

USP Expands Presence in India.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

A report commissioned by FDA evaluates the QbD program.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

Smartphones could become the product-authentication tool of choice. Contains online bonus material.

A summary of the latest steering committee and expert working groups' meeting.