Manufacturing Execution Systems (MES) bridge the information gap between ERP systems and process control systems. When these type of systems are used in a GMP regulated environment these systems may be subject to validation. ISPE issued a Good Practice Guide (GPG) on this subject.
After a summary of GAMP 5 and ISA-95, the GPG is explained in a practical way.
Validation, GAMP and 21CFR11
Validation in the pharmaceutical (and medical device) industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.
Validation according the FDA is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.
Validation also concerns computerized systems. The ISPE’s guide GAMP® 5 A Risk-based Approach to Compliant GxP Computerized Systems published in February 2008 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
- Understanding of specific requirements for production in industries which belongs to the rules of the FDA
- Know the requirements for valided systems
- Understanding the GAMP guidelines for processes for use in specification, installation and qualification of validaded systems
- Understanding the relations between GAMP and software development life cycles
- Understanding the requirements for management of electronic records and for the creation and management of documents with an electronic signature
- Know a recovery method to develop compliancy with 21 CFR part 11