David M. Bliesner - Laboratory Control System Operations in a GMP Environment

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David M. Bliesner, Ph.D.

Delphi Analytical Services, Inc.

Indian Rocks Beach, Florida

This edition first published 2020

© 2020 John Wiley & Sons Inc.,

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In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of experimental reagents, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each chemical, piece of equipment, reagent, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Cataloging-in-Publication Data

Names: Bliesner, David M., author.

Title: Laboratory control system operations in a GMP environment / David M. Bliesner.

Description: Hoboken, NJ : Wiley, [2020] | Includes bibliographical references and index.

Identifiers: LCCN 2019052264 (print) | LCCN 2019052265 (ebook) | ISBN 9781119529231 (cloth) | ISBN 9781119529279 (adobe pdf) | ISBN 9781119529293 (epub)

Subjects: LCSH: Medical laboratories--Quality control. | Laboratories--Management. | Pharmacy--Research. | Manufacturing processes--Quality control.

Classification: LCC RB36.3.Q34 B55 2020 (print) | LCC RB36.3.Q34 (ebook) | DDC 610.28/4--dc23

LC record available at https://lccn.loc.gov/2019052264

LC ebook record available at https://lccn.loc.gov/2019052265

Cover Design: Wiley

Cover Image: © Image Journal-Photography/Getty Images

To my wife and best friend, Kathy .

Regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate that companies who manufacture drugs for human and animal use be operated in a state of control by employing conditions and controls commonly referred to as good manufacturing practices (GMPs). In the United States the GMPs or CGMPs (where C = current) are codified in 21 Code of Federal Regulations Parts 210 and 211. In the European Union the GMPs are described in EudraLex – Volume 4, the Good Manufacturing Practice (GMP) guidelines. Other Regulatory bodies, such as the World Health Organization (WHO) and the International Council for Harmonization (ICH) also provide requirements and guidelines with respect to GMPs.

At the turn of the twenty-first century the FDA was actively engaged in regulatory actions against pharmaceutical companies whom they determined to be in significant violation of the CGMPs. As part of FDA's actions, several large companies entered into voluntary legal agreements referred to as Consent Decrees. These agreements existed for the expressed purpose of correcting the deficiencies related to CGMPs. Consent Decrees routinely require the contracting of independent third-party expert consultants. These consultants' duties include performing a baseline audit of the offending facilities, documenting their findings and helping the companies develop and implement corrective action plans.

To help collect evidence to support regulatory actions, FDA began using a Quality Systems approach to evaluate a firm's level of GMP compliance.

The Quality Systems approach is a scheme of systems for the manufacture of drugs and/or drug products. The general scheme of systems FDA used for auditing manufacture facilities consists of the following:

1 Quality System

2 Facilities and Equipment System

3 Materials System