Understand GAMP5 And Practice Those Good Guides In Instrument Development

Good Automated Manufacturing Practice Guide for A Risk-Based Approach to Compliant Gx P Computerized Systems(the latest version is No.5, named as GAMP5)focus on the compliant Gx P computerized System validation, and provide serials of approaches and good practice guides for pharmaceutical industry to compliant the regulation from Gx P rules, and aim for achieving the safeguard of “Patient safety, Products quality, and Data integrity”.GAMP5 is refered in an OEM development project. A corp.(as device user, complianted by Gx P rules) and B corp.(as device vendor) co-work together according GAMP5 concepts、opearation procedures and detailed good practice guidances, which include project management, quality assurance, rick evaluation, requirement collection and specification definition, design and validation and so on. GAMP5 is a good framework to effectively promote the A corp. and B corp. work hard to achieve their consistent bussiness interests.As a released book by ISPE(International Society for Pharmaceutical),authorized by pharmaceutical companies and recommended by government regulators in the wide world the GAMP5 is keeping update in the past thirty years and now is accepted as good framework for computerized system validation. Therefore, author think there have obvious values to introduce GAMP5 into other industries. Author think GAMP5 is a good reference while someone wants to build up a qualification system or development processes. GAMP5 as a certified method framework is particularly relevant for institutions with lack SOP(Standard Operation Processes) or people who want to learn more even if they don’t work for pharmaceutical industry.