Asif E.S., Usmani S.B. (eds.) Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide

CRC Press, 2024. — 265 p. — ISBN 9781032432052.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.Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP).
Concept of Calibration
Reference Standards and Reagents
Chemical Tests
Physical Testing of Raw Materials, Intermediate, and Finished Products
Data Integrity
Process Validation
Protocol Generation
Sampling and Testing Plan
Process Validation Report Writing
Cleaning Validation
Method Development and Method Validation
Qualification and Its Segments
User Requirement Specification
Functional Specification
Stability Studies, Stability Indicating, and Methods Degradates
Technology Transfer
Dispensing
Production
Packaging
Role of Quality Assurance
Role of Quality Control
Logistics – Cold Chain Supply
GMP for Biologics and Similar Medicines
QA/QC Release