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(a) For every batch of drug products purporting to be sterile and/or pyrogen-cost-free, there shall be ideal laboratory tests to ascertain conformance to these prerequisites. The exam procedures shall be in writing and shall be adopted.A consumer usually cannot detect (as a result of scent,
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The presentation elaborates to the technology transfer occurring in production phase. Production section primarily concerns with validation studies and scale-up. Validation scientific tests such as effectiveness qualification, cleansing validation and procedure validation is carried out by R&D depar