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.
The fact that GMP audits in the pharmaceutical and biotechnology industries have to be evaluated and with very limited resources has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations which are required to implement FDA, EMA, MHRA, WHO, TGA, PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits.The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities.
Features
An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards.
Assists the readers in understanding the importance of GMP and how they can apply each aspect in their working environment. Covers a global regulatory landscape. Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
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
Mustafa Edik, after graduating as a chemist from university, 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 served the Turkish Atomic Energy Authority (TAEA) as principal GMP auditor and consultant for six years. TAEA was audited by the Republic of Turkey's Ministry of Health and granted a GMP certificate for five 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 8,000 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 a 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 Turkey, 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 completed his second university degree in biopharmaceutical sciences BSc (Hons) at Atlantic Technological UniversityIreland. He is the author of a chapter in the book Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, published by the Parenteral Drug Association (PDA).
