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APQR shall be prepared for your batches which happen to be produced for that Business objective. APQR shall be well prepared irrespective of variety of batches made over the 12 months.”twelve Every single of these concepts, nonetheless, faces two complications. The primary is simple — ways to combination broadly different specific Choices so
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Controlling electronic batch manufacturing records (EBMR) comes with its own set of problems and things to consider. From making certain info protection and confidentiality to program validation and routine maintenance, and addressing improve management and scalability, this area will provide insights to the important areas that should be regarded.
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