What is GAMP 5 Compliance?
GAMP® (a trademark of the International Society for Pharmaceutical Engineering) is the acronym for Good Automated Manufacturing Practices, a GMP that the FDA has decreed a guideline to be used by FDA regulated developers, processors and manufacturers of drugs, dietary supplements and medical devices. GAMP covers all aspects of production from the raw materials, facility and equipment to the training and hygiene of staff. One of the core principles of GAMP is “quality by design” which designates that quality must be built into each stage of the manufacturing process. GAMP® guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
GAMP 5 is the current revision which has been significantly updated to align with the concepts and terminology of recent regulatory and industry developments, and when applied with expertise and good judgment, offers a robust, cost effective approach to researching, developing, processing and producing FDA regulated products.
InstantGMP™ MD & PRO Meets GAMP 5 Validation Standards.
GAMP 5 in InstantGMP
InstantGMP™, a manufacturing execution system, and electronic batch production record system has been developed per GAMP 5 guidelines to provide thorough solutions to the current business needs of developers, manufacturers and processors of FDA regulated products and respective consultants who, upon utilizing InstantGMP™ products become compliant with FDA recommended GAMP 5 guidelines.
The Software Development Life Cycle steps and the Computer Validation steps that were used in developing Version 3.0 of InstantGMP™ guarantee compliance with 21 CRF Part 11, GAMP and GMPs. The documents generated in this process are listed below:
- Software development life cycle policy
- Business requirements specification
- User requirements specification
- Function specification
- Security scheme
- Detailed design specification
- Unit test/Factory acceptance test scripts
- Requirements traceability matrix
- Source code documentation
- Design and code standards
- Source code review form
- Software release form
- Computer system validation policy
- Master validation plan
- Installation qualification
- Operational qualification