FDA Regulations and Guidance Documents
- FDA Part 22 – CGMP for Finished Pharmaceuticals, Subpart D–Equipment Sec. 211.68 Automatic, mechanical, and electronic equipment
- Guide to Inspection of Computerized Systems in Drug Processing, Reference Material and Training Aids for Investigators, February 1983
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
- Pharmaceutical CGMP’s for the 21st Century: A Risk Based Approach, August 2002
- Final Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application, August 2003
- ICH – Guidance For Industry – Q9 Quality Risk Management, June 2006
Industry Guidance Documents Links
- Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
- GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
- GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records and Signatures
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
- GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
- GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems
- Baseline Guide Volume 5: Commissioning and Qualification
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
- ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Related Industry Links
- Control System Integrators Association (CSIA)
- International Society of Automation (ISA)
- International Society of Pharmaceutical Engineering (ISPE)
- Pharmaceutical Industry Association of Puerto Rico (PIA)
- College of Engineers and Surveyors of Puerto Rico (CIAPR)
- National Minority Supplier Development Council (NMSDC)
- Puerto Rico Minority Supplier Development Council (PRMSDC
- Mid-States (Indiana) Minority Supplier Development Council (MSMSDC)
