PDA TR No. 56-治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用（API或生物活性成分）-2016(1).pdfVIP

Technical Report No. 56 (Revised 2016) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance) Paradigm Change in ® Manufacturing Operations PDA Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (Revised 2016) Technical Report Team* Authors Amnon A. Eylath, MAL Broad Spectrum GxP