GMP Audits in Pharmaceutical and Biotechnology Industries

ISBN-13: 9781032257303 / Twarda / 2024 / 464 str.

Mustafa Edik

Opis

This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as auditors in organizations that follow FDA, EMA, MHRA, WHO, TGA, PIC/S regulations.

Spis treści

Dedication

Preface

Author Biography

Abbreviation

Chapter 1 - The Concept of Quality

Chapter 2 - GMP Audits

Chapter 3 - GMP Auditing in Various Areas

Chapter 4 - Auditing Pharmaceutical Quality Management System

Chapter 5 - Alternative Auditing Methods

Chapter 6 - Audit Question Examples

　

O autorze

After graduating as a Chemist from university, Mustafa began his 25-year-plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP, and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Türkiye, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named "Good Distribution Practices".