Regulatory Oversight

Operators are hit hard by breakage problems and strike out on FDA inspections.

The authors describe the critical aspects of an ideal fermentation services provider.

The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11.

They may have seemed harmless at first, but these ideas took a big bite.

Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.

The steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 "Quality Systems" last week at a meeting in Portland, Oregon.

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Customers complaining lead to some serious explaining.

With rising drug deveopment costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entities in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards.

WFI system deficiencies and damp tax records cause problems for two plants

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

A. Nair discusses patent disputes in India.

If not properly monitored, filters and plastic bags can keep back more than they should.

The US Food and Drug Administration released a final guidance on protocol for testing sterile products.

The US Food and Drug Administration posted on its website a Jan. 24 Warning Letter to Novartis Vaccines and Diagnostics.

FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

If at first the product fails, then inspect, inspect again

A wave of pharmaceutical expansions is expected in Europe this year, surprisingly by Indian companies.