Displaying 1–25 of 64 results for cGMPs

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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.

Amendment to the cGMP Regulations for Finished Pharmaceuticals

(Whitepaper)

The FDA is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Amending the regulations will modernize or clarify some of the CGMP requirements, as well as harmonize some ...

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.

Unlocking the Power of Pharmacovigilance

(Whitepaper)

The idea that controlled clinical trials can establish product safety and effectiveness is a core principle of the pharmaceutical industry. Neither the clinical trials process nor the approval procedures of the FDA, however, can provide a perfect guarantee of safety for all potential consumers ...

Draft Guidance : Bioequivalence Recommendations for Specific Products

(Whitepaper)

This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence studies for specific drug products to support abbreviated new drug applications. Under this process, applicants planning to carry out such studies in support of their ANDAs will ...

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.

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 ...

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.

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.

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).

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.

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.

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.

A Profile of the Pharmaceutical Manufacturing Industry

(Whitepaper)

Aiming to develop integrated environmental policies that address the inter-relationships among pollutant releases to air, water and land, in the late 1990s EPA adopted a whole-facility focus. Recognition of the need to develop an industrial “sector-based” approach within the EPA Office of ...

Formal Dispute Resolution: Scientific and Technical Issues Related to ...

(Whitepaper)

This document (Final Guidance, issued January 2006) is intended to provide guidance to manufacturers of veterinary and human 19 drugs, including human biological drug products, on how to resolve disputes of scientific 20 and technical issues relating to current good manufacturing practice (CGMP) ...

Innovative Drug Development in the Context of FDA Regulation

(Whitepaper)

The author describes what the pharmaceutical industry and FDA need to do to escape the current crisis of public confidence.

U.S.A. GMPs: What Offshore API Manufacturers Need to Know

(Whitepaper)

This 341-page document, based on a course that was presented at Beijing University last year by Nicholas Buhay, Deputy Director of Manufacturing and Product Quality for FDA's CDER, summarizes GMP requirements and provides background on the history of the regulations within the U.S.

Process Modeling and Control Challenges in the Pharmaceutical Industry

(Whitepaper)

In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists.

Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and ...

(Whitepaper)

In 2004, several high-profile drug safety cases raised concerns about FDA's ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. In this report, GAO (1) describes FDA’s organizational structure and process for ...

IT and Data Security: Deloitte Assesses Pharma's Readiness

(Whitepaper)

Deloitte Touche Tohmatsu (DTT) surveyed a global representation of leading life sciences executives to determine the security issues facing the industry. The resulting study presents industry trends, security considerations that go beyond the realm of IT, and issues such as business continuity ...

[Report on] the Food and Drug Administration’s National Drug Code Directory

(Whitepaper)

HHS’ OIG found that the Directory is incomplete (with an estimated 9,187 prescription drug products missing) and inaccurate, (with an estimated 34,257 drug products no longer on the market or listed in error). The Office’s report also concluded that FDA’s drug product listing process and lack of ...

Guidance for Industry: Characterization and Qualification of Cell Substrates ...

(Whitepaper)

The U.S. Food and Drug Administration (FDA) on Sept. 28, 2006 issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and ...

From Procedural to Risk-Based Compliance and Enforcement

(Whitepaper)

In this paper, ARC Advisory Group analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharma manufacturers and the FDA.

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