The Certified Pharmaceutical GMP Professional Handbook

Description

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.
This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Sujets

• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• ASQ
• Engineering
• Technology
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 23 mai 2016
• Nombre de lectures: 0
• EAN13: 9781951058906
• Langue: English

Extrait

The Certified Pharmaceutical GMP Professional Handbook



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The Certified Pharmaceutical GMP Professional Handbook
Second Edition
Mark Allen Durivage, Editor
ASQ Quality Press
Milwaukee, Wisconsin



American Society for Quality, Quality Press, Milwaukee 53203
© 2016 by ASQ
All rights reserved. Published 2016
Library of Congress Cataloging-in-Publication Data
Names: Durivage, Mark Allen, editor.
Title: The certified pharmaceutical GMP professional handbook / Mark Allen
Durivage, editor.
Description: Second edition. | Milwaukee, Wisconsin : ASQ Quality Press,
2016. | Includes bibliographical references and index.
Identifiers: LCCN 2016011717 | ISBN 9780873899338 (hard cover : alk. paper)
Subjects: LCSH: Pharmaceutical industry—Quality control. | Drug development.
| Drugs—Standards.
Classification: LCC RM301.25 C456 2016 | DDC 615.1/9—dc23
LC record available at http://lccn.loc.gov/2016011717
ISBN: 978-0-87389-933-8
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: Seiche Sanders
Acquisitions Editor: Matt T. Meinholz
Managing Editor: Paul Daniel O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press .



List of Figures and Tables
Table 1.1 Food and Drug Administration amendments to the Food, Drug, and Cosmetic Act.
Table 6.1 Three categories of changes based on potential for adverse effect on identity, strength, quality, purity, or potency of a drug product.
Table 6.2 The rapid alert system alerts are classified from 1 to 3 depending on the expected risk presented to the public or animal health by the defective product.
Figure 7.1 Formatting requirements for a site master file.
Table 7.1 Site master files contain nine chapters.
Table 7.2 Differences between applications and drug master files.
Table 7.3 Types of drug master files.
Figure 8.1 Comparison of ISO 9001:2008 to ISO 9001:2015.
Table 8.1 Technical activities included in the product life cycle for new and existing products.
Figure 8.2 Components of a quality manual.
Figure 8.3 Management of outsourced activities and purchased materials.
Figure 8.4 Pharmaceutical life cycle.
Table 8.2 Application of process performance and product quality monitoring system throughout the product life cycle.
Table 8.3 Application of corrective action and preventive action system throughout the product life cycle.
Table 8.4 Application of change management system throughout the product life cycle.
Table 8.5 Application of management review of process performance and product quality throughout the product life cycle.
Figure 10.1 Some risk management tools.
Table 10.1 Typical FMEA rating scheme.
Table 10.2 Typical RPN action requirements.
Table 10.3 Typical criticality and occurrence action requirements.
Figure 10.2 Fault tree analysis example.
Figure 12.1 Typical change control process.
Table 13.1 Application of a corrective action and preventive action system throughout the product life cycle.
Figure 13.1 Flowchart of interactions of a quality system model.
Figure 13.2 Typical CAPA feeder systems.
Table 14.1 First-, second-, and third-party audits.
Table 14.2 System, process, and product audits.
Table 14.3 Typical audit nonconformance definitions.
Figure 15.1 Typical documentation hierarchy.
Figure 15.2 Example of a correction done according to regulations.
Figure 15.3 Specific retention periods are identified in the GMP regulations.
Figure 18.1 Example of suppliers to a pharmaceutical company.
Table 19.1 Tests and specifications for the principal pharmaceutical waters as per European Pharmacopeia.
Figure 19.1 Six methods for testing for bacterial endotoxins.
Figure 20.1 The aseptic processing guidance identifies seven areas that should be scrutinized.
Figure 20.2 Risk analysis should incorporate a minimum of five separate analyses.
Table 22.1 Typical universal and product-specific tests for chemical drug substances.
Table 22.2 Typical analytic tests for chemical drug products (for tablets and capsules).
Figure 23.1 Raw data attachment example.
Figure 23.2 Correct documentation of an error example.
Figure 23.3 Accuracy versus precision.
Figure 24.1 Example label for purchased reagents.
Table 24.1 Typical solution expiry dates.
Table 25.1 Definitions of ICH conditions.
Figure 25.1 Shelf life estimation for assay.
Table 28.1 Cleanroom classification (ISO 14644-1:1999).
Table 28.2 Recommended limits for microbial contamination (ISO 14644-1:1999).
Table 28.3 Maximum permitted number of particles/m 3 .
Table 28.4 Recommended limits for microbial contamination.
Table 28.5 Rule of thumb for recommended air changes per hour based on class of cleanroom.
Table 28.6 Required and optional testing necessary to ensure proper cleanroom operation and compliance (ISO 14644-2:2000).
Table 28.7 Gowning area particle generators.
Table 28.8 Austin contamination index.
Table 28.9 Cleanroom gowning recommendations.
Figure 29.1 Changes may require the revalidation of utilities.
Figure 31.1 Process validation decision tree.
Figure 31.2 Validation life cycle.
Figure 32.1 Example calibration label.
Figure 32.2 MSA/TMV study life cycle considerations.
Figure 34.1 Automated and computerized systems are recognized to have a typical life cycle.
Figure 34.2 Software validation decision tree—legacy software.
Figure 34.3 Software validation decision tree—new software.
Table 34.1 GAMP classifications for software types, and associated validation expectations.
Table 35.1 ISO 22301:2012 requirements for setting up and managing a business continuity management system.
Figure 35.1 Plan–do–check–act cycle applied to ISO 22301:2012.
Table 39.1 Temperature conversion formulas.
Figure 40.1 Steps to ensure that materials used in the manufacture of finished dosage forms do not contain harmful biologic agents.
Figure 40.2 Typical pharmaceutical supply chain.
Table 43.1 Cleanroom gowning requirements as specified by EU GMP, ICH, and Health Canada.
Figure 46.1 Critical control point decision tree example number 1.
Figure 46.2 Critical control point decision tree example number 2.
Figure 47.1 “Contamination” cited in 21 CFR 211.
Figure 49.1 Several measures that can help avoid cross-contamination.
Table 52.1 Three typical classifications of common defects.
Table 53.1 Common plastics and their properties.
Figure 53.1 Typical final packaging process.
Figure 54.1 Labeling operations.
Table 56.1 Variables and attributes control chart selection.
Figure 57.1 Clinical trial phases depicting increasing GMP requirements.
Figure 60.1 Relationship between statistical control limits and product specifications.
Figure 60.2 Control chart interpretation rules.
Table A.1 US, EU/PIC-S, Canadian, and WHO GMPs.
Table A.2 FDA cGMP and quality system elements.


Acronyms and Abbreviations
A
AAF —accelerated aging factor
AAT —accelerated aging time
ACC —air chemical cleanliness
ACCME —Accreditation Council for Medical Education
ADE Report —Adverse Drug Experience Report
ADME —absorption, distribution, metabolism, and excretion
AE —adverse event
AHU —air-handling unit
AIP —Application Integrity Policy
ANDA —Abbreviated New Drug Application
AOAC —Association of Official Analytical Chemists