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Design of cGMP compliant systems:

The foremost issue in designing and implementing a cGMP compliant system is the provision of solid, meaningful documentation that is respectful of the User Requirements and resulting Design Specifications. The documentation must be supportive of the Commissioning and Qualification Testing that is performed on the system following implementation. The documentation must be highly structured and well-organized. A high degree of linkage must exist between the various design documents and engineering deliverables. Good Engineering Practices must be followed with regards to Design Reviews, Management of Change, and overall traceability of the design. We have adopted the GAMP-4 Lifecycle Development Model (V-model) for ALL of our internal design and software development methods. As active members of the International Society of Pharmaceutical Engineers (ISPE), we are fully cognizant of the issues and requirements for achieving compliance with current GMP regulations for Active Pharmaceutical Ingredients and Bulk Pharmaceuticals, and with 21 CFR Part 11 for the handling of electronic data. We produce process designs and system software that meet specification, are thoroughly documented and are fully capable of being validated.



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