Автор: Donald C. Singer, Raluca-Ioana Stefan, Jacobus F. van Staden
Название: Laboratory Auditing for Quality and Regulatory Compliance
Издательство: CRC Press
Год: 2005
ISBN: 9781841842202; 1841842206
Серия: Drugs and the Pharmaceutical Sciences (Book 150)
Язык: English
Формат: pdf
Размер: 15,8 mb
Страниц: 496

There is an inherent similarity between planning and performing an audit of a laboratory and planning and operating a laboratory. Each area of operation that builds integrity and ensures accuracy and consistency in results is an area that is scrutinized by an effective audit. The laboratory is a facility requiring sufficient services (electrical, water, air) to keep it operating continuously and efficiently. The services that support the facility, its equipment, its operations, and its people should be monitored. An audit can determine if quality is built into the services. Laboratory space, the designation of areas for particular operations, flow of materials, and flow of people serve to design an appropriate plan to meet the needs of customers and employees for testing capability and laboratory safety. An audit can identify if the plans do indeed meet the needs of customers. Training and background of scientists who perform the sample handling, testing, and reporting of results must fit the expertise required to successfully carry out the laboratory operations. And an audit can identify strengths and weaknesses of staff expertise, hiring, and retention of scientists.

This book is focused on analytical (biology, biochemistry, chemistry, and microbiology) laboratories that support regulated industry. This book is not intended to cover all laboratory operations, but to identify certain tools, techniques, approaches, and philosophies that can be used to evaluate the quality of most laboratory operations.