Friday, February 10, 2012 : Process Analytical Technology - Multivariate Statistics, Regulatory Guidance, Good Manufacturing Practice, Quality Assurance

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Good Manufacturing Practice

Good Manufacturing Practice:

 

PAT is as much about engineering and automation as it is about real-time analytics.  The following guidance documents make good reading from the engineering perspective.  These standards are written by industry, and not all of them pertain solely to pharmaceutical manufacturing.

 

GAMP5 (ISPE)

 

ISA 88:  The International Standard for Flexibility in Manufacturing.

 

ISA 95: The International Standard for the Integration of Enterprise and Control Systems.

 

ISA-100: Wireless Sensor Systems.

 

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