Tag: <span>documentation</span>

The Establishment of a Documentation System and Quality Control Strategy for the Plantibody HB-01 Production Employed in rHBsAg Purification for Pharmaceutical Use

Regulatory agencies routinely announce changes in the GMP (Good Manufacturing Practices) norms and quality standards designed to guarantee that every product retains characteristics required for its pharmaceutical use.The alignment with emerging regulatory requirements is mandatory, therefore, to assure production process consistency, as well as the safety and efficacy of the finished product…

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Biologics Production Regulatory

documentation GMP immunopurification plantibody quality control transgenic plants