Process Validation
工艺验证
3/27/2009 Shanghai
Contents
Validation System Regulatory Requirements 法规要求 Process Validation in the Product Lifecycle
1.Stage I- Process Design 工艺设计
2.Stage II –Process Qualification 工艺认证
3.Stage III – Continued Process Verification 工艺确认
Protocol Examplevalidation verification
Report Example
Why Validate?
•Process validation is a requirement of: The Current Good Manufacturing Practices
(cGMP) Regulations for Finished Pharmaceuticals - 21 CFR Parts 210 and 211（美国）
Directive 91/356/EEC (EU GMP Guide and
Directive, first issued 1989, reissued 1991（欧盟）
Why Validate?
Process validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under 501(a)(2)(B) 0f the Act, which states the following:
A drug…shall be deemed to be adulterated…if…the
methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with
current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess.
Why Validate?
cGMP requirements for Process Design
211.42Design of Facility 厂房设施的设计211.63Design of Equipment 设备的设计211.100Design of Production and Control Procedures 生产和控制规程的设计
211.160Design of Laboratory Controls 实验室控制的设计