Regulatory/GMP Compliance

The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances.

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.

An ounce of contamination usually leads to a mountain of investigation.

The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.

Some GMP agents seem to find a way to squander time, money, and common sense.

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.

Short-term problems in software or hardware lead to long-term manufacturing troubles.

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.

The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1 Federal Register.

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).

The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).

GMP agents report on old products, aseptic violations, and unexpected emotions.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

The source of a problem reveals itself after some investigation, or it may crash down on you.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.