Following installation by the equipment supplier, the produc…
Following installation by the equipment supplier, the production department requests immediate approval to begin commercial manufacturing in order to meet increasing market demand. During the startup meeting, the Quality Manager explains that the equipment cannot be released for routine use until all required qualification activities have been successfully completed and documented.According to GMP principles,1. Which qualification steps should be completed before the equipment is used in routine manufacturing, and (6)2. Why are these activities necessary? (3)
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