The pharmaceutical quality system ensures that process performance is suitably achieved, product quality is regularly met, improved opportunities are identified and evaluated, and knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies.
This book aims to develop a tool to substantially decrease the number of inspection observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms.
The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System
