Validation and compliance - Pharmaceutical Technology

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Validation and compliance
Information about pharmaceutical manufacturing compliance and validation issues.

FDA's CMC Pilot Program Moves Forward

September 12, 2006

ePT--the Electronic Newsletter of Pharmaceutical Technology

Washington, DC (Sept. 12)—The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here

FDA Sets Guidance Agenda

September 7, 2006

ePT--the Electronic Newsletter of Pharmaceutical Technology

Washington, DC (Sept. 1) — In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.

A Compliance Perspective on Dissolution Method Validation for Immediate-Release Solid Oral Dosage Forms on Automated Instrumentation

September 2, 2006

Pharmaceutical Technology

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

21 CFR Part 11 Revision Delayed, But Moves Forward

April 24, 2007

INTERPHEX Show Daily

Interphex, New York, NY (Apr. 24)-Although the second revision of 21 CFR Part 11, the Electronic Records and Signatures Rule, has not been finalized, there is some progress being made. This was the topic of a presentation given by John English, manager of computer system validation for BE&K BioPharm at today?s Interphex Pharmaceutical Manufacturing Conference and Exhibition.

Qualification, Validation, and Verification

April 2, 2007

Pharmaceutical Technology

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.

Warning Letters Demand Stop to Unapproved Ergotamine Manufacture and Distribution

March 8, 2007

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

Maintain Your Moving Parts

March 2, 2007

Pharmaceutical Technology

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

Actavis receives FDA Warning Letter

March 1, 2007

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.?

FDA Issues Warning Letter to Bell-More Laboratories

March 1, 2007

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

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