WHAT IS IT?
Good Manufacturing Practice (GMP) compliance is part of a quality system covering the manufacture and testing of medical devices, active pharmaceutical ingredients, diagnostics, foods and pharmaceutical products. GMP standards are concerned with both production and quality control.
WHY IS IT IMPORTANT?
GMP compliance enforces global quality guidelines for pharmaceutical and medical device manufacturers to follow. It offers guidance on:
– Adhering to processes that will satisfy the regulatory requirements
– A scalable approach to GxP compliance through the complete lifecycle
– Driving towards a risk-based approach
– Effective supplier relationships
– Use of existing documentation and knowledge
– Continuous improvement within QMS
– Quality by design
– Effective governance to achieve and maintain GxP compliance
– Helping bring down the cost of compliance
The development of automated processes has led to GAMP (Good Automated Manufacturing Practice) which provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for the intended use in an efficient and effective manner. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
GMP compliant systems are implemented within any organization manufacturing and testing pharmaceuticals and/or medical devices. To find out more about the GMP standards and what GMP is, visit www.ispe.org for more information.