Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics: 1st Edition (Hardback) book cover

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

1st Edition

Edited by Carmen Medina

CRC Press

704 pages

Purchasing Options:$ = USD
Hardback: 9780824740788
pub: 2003-12-09
SAVE ~$31.50
eBook (VitalSource) : 9780429216404
pub: 2003-12-09
from $28.98

FREE Standard Shipping!


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.


"…The book captures the reader's attention from the first chapter and paves a lively way for prosecution of further independent studies….One of those invaluable books which any reader will want to have beside him as he comes into face with questions of FDA's changing and regulatory demands….

"…the strategies and programs offered in this book can significantly decrease a company's compliance vulnerability and regulatory liability and increase its overall quality."

-Current Engineering Practice

"…gives manufacturers sound, practical advise on inspection readiness and overall compliance."


Table of Contents

Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements during the drug development process, Martin D. Hynes; validation - a new perspective, James Agalloco; validating analytical methods for pharmaceutical applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer; the stability testing programme, Maria Geigel; computer validation - a compliance focus, Timothy Horgan and Timothy Carey; compliance issues associated with cleaning in the pharmaceutical industry, William E. Hall; the batch record - a blueprint for quality and compliance, John Fugate; change management - a far reaching, comprehensive and integrated system, Susan Freeman; the vendor qualification programme, Eizabeth M. Troll and Karen L. Hughes; handling laboratory and manufacturing deviations, Robert B. Kirsch; the internal audit programme - a quality assessment, Graham Bunn; pre-approval inspections - the critical compliance path to success, Martin D. Hynes; international compliance issues and trends, Alan G. Minsk; strategic planning for compliance and regulatory defensiveness, Ron Johnson; unique and unprecedented compliance challenges in the biologics area, Anne Hoppe and Curtiss Scribner; the impact of total quality performance on compliance, Carmen Medina, Judith Beach, Valerie Palumbo and Douglas B. Poucher.

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology