Regulatory Oversight

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

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).

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

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.

The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

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).

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Look ahead to keep from falling behind.

The Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.

AAI, AstraZeneca, Biovail, West, more

London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.

Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.

Breaking up is easy to do.

Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.