Displaying 51–64 of 64 results for cGMPs

Sort By Relevance Sort By Date

CDER's 2004 Report to the Nation: Improving Public Health Through Human Drugs

(Whitepaper)

This 66-page report discusses what was accomplished by FDA's Center for Drug Evaluation and Research in 2004, and looks at the initiatives it will be tackling this year and in the near future.

21 CFR 11: Risks of Noncompliance

(Whitepaper)

This paper addresses major concerns about interpretation of the regulation and the ensuing release of "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application" in August 2003. It also explains FDA's clarification of two points: (1) FDA intends to ...

Software-Based Validation of Processing Systems Following 21 CFR 11

(Whitepaper)

This technical applications article discusses the implications of 21 CFR Part 11 and how Siemens Simatic HMI can be used to facilitate validation.

Handling MSDSs and Global Hazard Communications

(Whitepaper)

Do you know all you need to know about global hazard communications and material safety data sheets? Marshall Denhoff of the American Industrial Hygienists Association shares best practices in this article.

Applications Note on Multipurpose Peeler Centrifuges

(Whitepaper)

The latest generation of multipurpose GMP-compliant peeler centrifuges have been designed to ease batch changes, prevent contamination and improve separation. This applications note from Riera Nadeu U.S.A. discusses considerations for specifying, cleaning and using this type of equipment.

FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic ...

(Whitepaper)

This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products (excluding blood and blood components).

Influenza Vaccine: Current Status, Lessons Learned and Preparing for the Future

(Whitepaper)

Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, testified Feb. 10, 2005, before the U.S. House of Representatives' Committee on Government Reform, regarding the present and future status of flu vaccine supply and demand.

Qualifying a NIR Spectrometer to Meet 21 CFR Part 11

(Whitepaper)

Clear goals and an early FAT prevented scope creep when at at-line NIR system needed to be validated for coating a pharmaceutical patch. Frederick H. Long, principal of Spectroscopic Solutions, outlines the secrets to this project's success.

Making Sense of FDA's Risk-Based Initiative

(Whitepaper)

Here's a no-nonsense three-page overview of FDA's 21st Century cGMP guidelines, written by attorney Patricia J. Kaeding, formerly of FDA's Office of Chief Counsel.

Aseptic Processing Final Guidance

(Whitepaper)

As part of its 21st Century cGMPs, FDA (jointly with HHS, CDER, and other agencies) offers guidance on aseptic processing used in the manufacturing of sterile drugs.

Combination Products: FDA Issues Draft of cGMPs

(Whitepaper)

In its recently released “Pharmaceutical cGMPs for the 21st Century—a Risk-Based Approach,” FDA provided some initial guidance on good manufacturing practice for combination products (such as drug and device pairings). This is a draft document, meant to elicit comments and concerns

FDA Goes "Final" with Its 21st Century cGMP Guidance

(Whitepaper)

FDA's final report on “Pharmaceutical cGMPs for the 21st Century — a Risk-Based Approach” is hot off the press. From aseptic processing to electronic record-keeping to quality systems, get your guidance here.

Sort By Relevance Sort By Date