1st Edition
Basics of Pharmaceutical Manufacturing and Quality Operations A Comprehensive Guide
This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry.
Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both sterile and non‑sterile areas. The book is a simple, concise, and easy to use reference tool covering basic quality concepts required by the pharmaceutical educational institutions and professional certification bodies. It describes details of all GXP activities that are directly related to Quality, Safety, and Efficacy of the products manufactured under the umbrella of Quality Operations, common testing methods which are used in any modern industry, Requirements of Validation and Qualification of equipment, facilities and processes, integral segments of Drug product manufacturing, storage, and distribution practices. The material provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product to enhance the GMP within the industry.
The book is written with the idea of providing basic knowledge to undergraduate students who are preparing to enter the industry at the end of their graduation. The book would also be beneficial for institutions conducting pharmaceutical technology study courses in terms of GMP and GLP applications.
Features:
- Provides readers and front line health care product manufacturers, all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements.
- Provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product and packaging material to enhance the GMP within the industry.
- Includes significant processes and steps in production for all common dosage forms.
- Explains how in‑process and finished products are released.
- Provides an ideal and effective tool for anyone starting Quality Assurance/Quality control/Production responsibilities.
Preface
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics – Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Biography
Erfan Syed Asif earned his PhD in organic chemistry and has expertise in various areas of quality operations with over 28 years of experience in pharmaceutical industries in Pakistan, UAE, Kingdom of Saudi Arabia, United States, and Canada. He has worked in U.S. FDA‑ and Health Canada‑approved facilities in various Leading roles. He has extensive experience in overseeing qualification projects for manufacturing equipment, utilities, systems, sterilization techniques, aseptic processes simulation, API site audits and sterile and non‑sterile products manufacturing processes, and decommissioning of equipment.
Usmani Shahid Bader obtained his Ph.D. in organic chemistry and has expertise in various areas of quality operations with over 25 years of experience in pharmaceutical industries in Pakistan and Canada. He has worked in a leading role in U.S. FDA‑ and Health Canada‑approved facilities. He has extensive experience in overseeing quality projects.
