Quality Systems

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.

Rockville, MD (Mar. 1)-Sending Warning Letters to 8 manufacturers and 12 distributors, The US Food and Drug Administration ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate.

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

The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.

The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.

FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.

Washington, DC (Feb. 22)-The Biotechnology Industry Organization criticized two separate studies respectively released by the Pharmaceutical Care Management Association and Express Scripts, Inc. regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

Rockville, MD (Jan. 5)-The US Food and Drug Administration issued a Warning Letter to Bell-More Laboratories following the agency?s August 2006 inspection of the company?s Hampstead pharmaceutical facility.

Rockville, MD (Feb. 1)-The US Food and Drug Administration issued a revised warning letter to Actavis Totowa, LLC, citing ?significant deviations from the current Good Manufacturing Practice regulations.?

Princeton, NJ (Feb. 15, 2007)-Ranbaxy Inc., confirmed that federal officials conducted a search of its New Jersey offices on Feb. 14, 2007 and commented on its reported plan to acquire Merck's generics business.

InformexUSA, San Francisco (Feb. 14)-The Synthetic Organic Chemical Manufacturers Association is launching a new sustainable chemistry initiative, the International Center for Sustainable Chemistry.

Washington, DC (Feb. 7)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) submitted comments to the US Department of Homeland Security in response to proposed DHS regulations on chemical site security, asking DHS to take into consideration the unique nature of the specialty batch manufacturing sector.

The injunction blocks rules that required secondary wholesalers to supply pedigrees tracing the chain of custody to the maker.

As technology for impurity analysis improves, scientists are gaining better information and asking for more regulatory guidance.

"Quality by design" (QbD) and "quality risk management" at long last seem to be moving from the buzzword stage to becoming important influences on drug development and manufacturing. A series of quality standards issued by the International Conference on Harmonization (ICH) is encouraging the adoption of common quality-based drug manufacturing approaches designed to reach the "desired state" of drug manufacturing (i.e., more efficient, agile, flexible operations that can reliably produce high-quality drug products with less regulatory oversight). These developments reflect increased pressure to make pharmaceutical manufacturing more efficient and less wasteful and to encourage regulators in all regions to focus on the most critical issues affecting product quality and patient safety.

It's what's on the outside that counts, too.

When it comes to ethics, the adage "hindsight is 20/20" is especially applicable. Countless medical and psychological experiments-such as the 1932 Tuskegee syphilis study or Zimbardo's 1972 Stanford mock-prison experiment-were conducted in the name of science and are now plainly recognized as enormous violations of ethical and human rights.

Rockville, MD (Jan. 30)-The Food and Drug Administration?s Center for Biologics Evaluation and Research (CBER) is proposing an addendum to its current biologics reporting form to better classify potential recalls.

The US Food and Drug Administration announced the creation of the Office of the Chief Medical Officer as well as two important staff changes at the agency.

Rockville, MD (Jan. 12)-To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use. Though cattle products are used in 75% of pharmaceutical processes and 90% of biotechnology processes, the Agency says that no approved or investigational drug appears to contain bovine material that would be prohibited under the rule.

Washington, DC (Dec. 28)-The US Department of Homeland Security (DHS) has proposed regulations for improving security at high-risk chemical facilities, a category that may include some pharmaceutical production facilities.

An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.