Regulatory/GMP Compliance

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.

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

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

Process efficiency is measured not only by what is kept, but also by what is thrown away.

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

The "why" things are done in this industry is just as important as the "what"and "how."

Thin are the lines that separate stability, statistics, and chaos.

The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.

The US Food and Drug Administration sent Med-South Pharmacy a Warning Letter for producing large volumes of betamethasone acetate?betamethasone sodium phosphate without following current good manufacturing practices (CGMPs).

Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.

The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.

Poor processing and misguided projections lead to trashed product.

The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.

The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.

Production sometimes follows the law of supply and reprimand.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.

The good ol' days weren't always good.

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).