Validation and GAMP 5 Compliance
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 the 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, significantly updated to align with recent regulatory and industry developments. When applied with expertise and good judgment, these practices offer a robust, cost-effective approach to researching, developing, processing and producing FDA regulated products.
InstantGMP™ MD & PRO Meets GAMP 5 Validation Standards.
InstantGMP Validation and GAMP 5
InstantGMP™ is an all-in-one manufacturing and quality system with electronic batch records 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 using InstantGMP products can easily become compliant with FDA recommended Good Manufacturing Practices.
InstantGMP has incorporated the business processes and workflows that are regulated by the FDA 21 CFR Part 111, Part 211 and Part 820. It also meets the requirements for producing medical devices under ISO 13485. Since this system automates electronic signatures, 21 CFR Part 11 also applies. InstantGMP is validated to meet these principals and the guidance of General Automated Manufacturing Practices (GAMP 5).
The Software Development Life Cycle and the Computer Validation steps that were used in developing Version 3.0 of InstantGMP reinforces compliance with 21 CFR Part 11, GAMP-5 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
Get the details by downloading our Guide to InstantGMP Computer Validation.