PDA最新修订的第56号PDA技术报告，2016年修订版《阶段适用质量体系和cGMP在治疗性蛋白质原料药开发中的应用》概述了在整个产品生命周期内，以及从发现/研发阶段到第3阶段临床试验到商业上市，广泛良好生产规范（GMP）的理想状态。本报告还描述了一个临床试验制造的基本框架，用于完全商业开发和/或制造可能不是组织目标的场所（例如:。 g、 ，大学/补助金资助的调查人员，初创生物技术公司）。

PDA's newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch. This report also describes a basic framework for clinical trial manufacturing for sites where full commercial development and/or manufacturing may not be the organizational goal (e.g., university/grant-funded investigators, start-up biotech firms).