JB/T 20091-2007
Guidance on validation of pharmaceutical machinery (equipment) (English Version)
- Standard No.
- JB/T 20091-2007
- Language
- Chinese, Available in English version
- Release Date
- 2007
- Published By
- Professional Standard - Machinery
- Status
- Latest
- JB/T 20091-2007
- Scope
- This standard specifies the terms and definitions, principles, purpose, scope, procedures, plans, content, implementation and technical documents that the manufacturer should provide for pharmaceutical machinery (equipment) verification. This standard is applicable to the guidance of design qualification (DQ), installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of pharmaceutical machinery (equipment).
JB/T 20091-2007 Referenced Document
- GB 9969.1 General principles for preparation of instructions for use of industrial products
- JB 20067-2005 General rule of pharmaceutical machinery conform to good manufacturing practice
JB/T 20091-2007 history
- 2007 JB/T 20091-2007 Guidance on validation of pharmaceutical machinery (equipment)
