Sterile Manufacturing

Regulations, Processes, and Guidelines

Sam A. Hout

• Publisher: CRC Press
• Year: 2021
• Print ISBN: 9780367754358
• eBook ISBN: 9781000406122
• Edition: 1
• Topic: Medicine
• Subtopic: Business General

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products.

Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning.

The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

1 Introduction

The purpose of this book is to highlight key ideas and factors to coach and guide professionals involved in learning more about this important sector in pharmaceutical and biopharmaceutical manufacturing facilities including operational requirements. This book will cover various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH to emphasize GMP and PAI requirements in the sterile manufacture of medicinal products. This will also help compounding pharmacists and GMP inspectors and auditors. There are ample guidelines on this subject matter. The intent of this book is to present a simplified supplement with some very specific descriptions of aseptic processing techniques and methods based on personal experience and empirical knowledge.

Relevant and binding documents and information on sterile requirements could be researched in FDA aseptic processing guidelines, ISPE guides and baseline, ISO 14644-1/2, PIC/S, US Pharmacopeia, European Pharmacopeia, EU-GMP annex 1, and ICH guidelines. All GMP requirements apply to medicinal products for human and animal veterinary use.

Sterile manufacturing guides are intended to manage risk and introduce Quality by Design (Q...

Table of contents

• Cover
• Half-Title
• Title
• Copyright
• Contents
• Preface
• Acknowledgment
• Author Bio
• Chapter 1 Introduction
• Chapter 2 Data Integrity Compliance
• Chapter 3 Risk-Based Life Cycle Management
• Chapter 4 FMEA Manufacturing Procedure
• Chapter 5 Classified Areas
• Chapter 6 Sterile Manufacturing Facilities
• Chapter 7 Personnel behaviors, Personal Protective Equipment (PPE), and Process Flow
• Chapter 8 Quality Approach for Systems Validation
• Chapter 9 Dedicated Facilities
• Chapter 10 Contamination
• Chapter 11 Containment
• Chapter 12 Suppliers
• Chapter 13 Single-Use Technologies (SUT)
• Chapter 14 Master Qualification Plan
• Chapter 15 Water For Injection (WFI)
• Chapter 16 Integrated Facility Design
• Chapter 17 Sterile Techniques
• Chapter 18 Compliance
• Chapter 19 Controls
• Chapter 20 Barriers and Isolators
• Chapter 21 Quality Risk Management
• Chapter 22 Equipment Qualification (EQ)
• Chapter 23 Process Validation
• Chapter 24 Change Control
• Chapter 25 Analytical Testing of Raw Material Quality
• Chapter 26 Product Life Cycle
• Chapter 27 Quality by Design (QbD)
• Chapter 28 Sterilization
• Chapter 29 Cleaning Validation
• Chapter 30 Lyophilization
• References
• Glossary
• Bibliography
• Appendix I: System-Level Impact Assessment
• Appendix II: Instrument Criticality Assessment
• Appendix III: Required Testing (ISO 14644-2)
• Appendix IV: Contract Manufacturing Process Steps
• Appendix V: Equipment Qualification
• Appendix VI: API terms
• Appendix VII: Impurities – FDA Directive
• Appendix VIII: Master Qualification Plan (MQP) – Template
• Appendix IX: High-Level Risk Analysis – Template
• Appendix X: Cleaning Validation
• Index