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ASTM Standard E 2500 for Specification, Design and verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems & Equipment provides a science and “risk based” approach to assure that GMP equipment and systems are:
Fit for use
Perform satisfactorily
May be used in the manufacturing, processing, packaging and holding of a drug or therapeutic agent.
Good Engineering Practice (GEP) should underpin and support the specification, design and verification activities.
Old V/s New Approach
Role of Design/Engineering
What is SME?