PDA TR60中工艺验证主计划的描述

Process Validation Master Plan

工艺验证主计划

A process validation master plan may be initiated during Stage 1 to prepare for Stage 2 activities. It should outline the validation strategy and supporting rationale, and typically includes:

一个工艺验证主计划可能在阶段1到准备阶段2活动期间被发起，它应该描绘概述验证策略和支持原理，通常包括：

· Process characterization plan

工艺表征计划；

· Description of the manufacturing process and control strategy

生产工艺和控制策略的描述；

· Functions and responsibilities

部门与责任；

· PQ or PPQ plan:

PQ或PPQ计划；

PPQ strategy (e.g., single unit operations or a combination of unit operations, bracketing, family, or matrix approaches) and a list of individual protocols; applicable ancillary studies, (e.g., mixing, media preparation, inprocess pool hold time, resin lifetime)

PPQ策略（例如单个单元操作或单元操作的合并、括号法、分组法或矩阵法）和单个草案、适用的辅助研究清单（例如混合、培养基准备、中间过程池持续时间、树脂生命周期）；

· List of equipment and facilities to be used

所用的设备和设施清单；

· List of analytical methods and their status

分析方法和它们状态清单；

· Sampling plan

取样方法；

· List of protocols to be executed under the plan

在计划下将被执行的草案列表；

· Proposed timeline and schedule of deliverables

建议的时间表和交付排期；

· Procedures for handling deviations and revisions

处理偏差和升版的程序；

· Continued Process Verification plan

持续工艺确证计划；