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The investigation shall extend to other batches of exactly the same drug item together with other drug products that could have already been related to the precise failure or discrepancy. A penned document with the investigation shall be designed and shall contain the conclusions and followup.Regulatory Compliance Associates good quality assurance
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(d) Anyone proven at any time (both by healthcare examination or supervisory observation) to own an clear health issues or open up lesions that may adversely have an effect on the protection or high quality of drug items shall be excluded from direct contact with factors, drug products containers, closures, in-method supplies, and drug goods till t