Erfan Syed Asif, Shahid Bader Usmani

Basics of Pharmaceutical Manufacturing and Quality Operations (eBook, ePUB)

A Comprehensive Guide

• Format: ePub

Produktbeschreibung

This book describes "good practice" GxP activities that are directly related to quality, safety and efficacy in the pharmaceutical industry. The material provides guidance on how to evaluate, audit, qualify and approve a pharmaceutical product to enhance the GMP within the industry.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 200
• Erscheinungstermin: 14. März 2024
• Englisch
• ISBN-13: 9781003856351
• Artikelnr.: 69914392

Autorenporträt

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.

Inhaltsangabe

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