ABSTRACT

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

chapter 1|53 pages

Regulatory Submissions

ByPatricia Fritz, Anisa Dhalla

chapter 2|16 pages

Compliance Requirements During the Drug Development Process

ByMartin D.Hynes III

chapter 3|39 pages

Validation: A New Perspective

chapter 5|35 pages

The Stability Testing Program

ByMaria A. Geigel

chapter 6|24 pages

Computer Validation: A Compliance Focus

ByTimothy Morgan, Timothy Carey

chapter 8|27 pages

The Batch Record: A Blueprint for Quality and Compliance

ByTroy Fugate

chapter 10|22 pages

The Vendor Qualification Program

ByElizabeth M. Troll, Karen L. Hughes

chapter 11|47 pages

Handling Laboratory and Manufacturing Deviations

ByRobert B. Kirsch

chapter 12|28 pages

The Internal Audit Program: A Quality Assessment

ByGraham Bunn

chapter 13|26 pages

Preapproval Inspections: The Critical Compliance Path to Success

ByMartin D.Hynes III and Carmen Medina

chapter 14|48 pages

The Impact of Total Quality Performance on Compliance

ByCarmen Medina

chapter 15|25 pages

International Compliance Issues and Trends

ByAlan G. Minsk

chapter 16|19 pages

Strategic Planning for Compliance and Regulatory Defensiveness

ByRon Johnson

chapter 17|34 pages

Unique and Unprecedented Compliance Challenges in the Biologics Arena

ByAnne P. Hoppe, Curtis L. Scribner

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