Process automation has improved productivity and quality in many areas, and the pharmaceutical industry is no exception. Automation within this area has been driven by the need to ensure consistency and reliability throughout the production and packaging process.
Good automated manufacturing practice (GAMP) provides a strong set of guidelines of procedures to follow for the design, implementation and testing of an automated system within the pharmaceutical industry.
Applied Integration has successfully completed a number of projects to GAMP4 guidelines for pharmaceutical companies. Providing fully documented system design and development to ensure compliance to FDA regulations.
Standard GAMP4 Project documentation provided:
- Quality Assurance/Validation Plans
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System specifications including:
- User Requirements
- Functional Requirement Specifications
- Detailed Design Specifications
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Proper protocols including:
- Installation qualifications with version control of hardware and software components
- Operational/performance qualifications with complete traceability to requirements
- Code Review
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Commissioning Plan
- Factory Acceptance Tests
- Site Acceptance Tests
Applied Integrations ISO9001:2000 Quality System is based around the GAMP4 Guidelines.