Regulatory Oversight

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Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).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

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

Forty years ago, investors and business speculators shuddered at the prospect of working with India's pharmaceutical industry. The industry was plagued by archaic patent laws and insufficient infrastructure, and only multinational companies (MNCs) were able to exploit its crude resources and monopolistic legal framework. Struggling in the shadows of these MNCs were the Indian pharmaceutical entrepreneurs and a handful of producers. Because more than 70% of the pharmaceutical market value was in the hands of MNCs, India's indigenous pharmaceutical industry was floundering. Its amount of exports was negligible, and the domestic market outlook was bleak because of onerous government regulation.

The enactment of the Indian Patents Act of 1970, implemented in 1972, provided an open platform to the Indian pharmaceutical industry to adopt process patents to manufacture active pharmaceutical ingredients (APIs) and formulations without fear of infringement of product patents. This resulted in a phenomenal growth in the number of pharmaceutical manufacturing units, from 2257 in 1970, to 5156 in 1980, 16,000 in 1990, and more than 23,000 in 2005. This was accompanied by a steep increase in investment from Rs. 2.25 billion (approx. $250 million US) in 1973, to Rs. 45 billion (approx. $1 billion US) in 2002–03. The prices of the most advanced drugs dropped significantly in India, leading the Indian pharma sector to become more competitive while remaining extremely cost effective in the global market.

Mishaps in packaging labels serve as a reminder: the recall is in the details.

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.

Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.

Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.

Just because the wheels are turning doesn't mean they're going forward.