Operating systems Good Automated Manufacturing Practices

Note The instruments used in the laboratories vary significantly in the design and operation complexity. The validation requirements should reflect the level of complexity of the instrument. It is obvious that the amount of effort required to validate a simple pH meter will be different from that required for a fully automated dissolution system. The Good Automated Manufacturing Practice (GAMP)... 

Authorized written standard operating procedures (SOPs) for all sections of Good Manufacturing Practices guidelines are retained for reference and inspection. These SOPs are regularly reviewed and kept up to date by authorized persons. The reasons for revision are documented. A system is in place to ensure that only current SOPs are in use. Records of SOPs for all computer and automated systems are retained where appropriate. 

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