Regulatory/GMP Compliance

GMP experts act fast to resolve some unusual and difficult problems.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.

Readers give advice on their best approach to handling (batch) rejection

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

When accusations fly: 'Tis better to give than to receive.

The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.

The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

Production problems come in all shapes, sizes, and ... species.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

To err may be human, but to really mess things up, you need management.

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

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 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 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.

Customers complaining lead to some serious explaining.