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JB/T 20091-2007 English PDF

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JB/T 20091-2007English479 Add to Cart 3 days [Need to translate] Guidance on validation of pharmaceutical machinery(equipment) Obsolete JB/T 20091-2007

PDF similar to JB/T 20091-2007


Standard similar to JB/T 20091-2007

GB/T 36030   JB/T 20032   JB/T 20104   JB/T 20188   JB/T 20126   

Basic data

Standard ID JB/T 20091-2007 (JB/T20091-2007)
Description (Translated English) Guidance on validation of pharmaceutical machinery(equipment)
Sector / Industry Mechanical & Machinery Industry Standard (Recommended)
Classification of Chinese Standard C90
Classification of International Standard 11.120.30
Word Count Estimation 12,167
Date of Issue 2007-03-06
Date of Implementation 2007-09-01
Quoted Standard GB 9969.1; JB 20067-2005; pharmaceutical production and quality management practices (1998 Revision); safety technology Vessel Regulations (1999)
Regulation (derived from) ?National Development & Reform Commission Announcement 2007 No.16
Issuing agency(ies) Ministry of Industry and Information Technology
Summary This standard specifies the pharmaceutical machinery (equipment) to verify the terms and definitions, principles, purpose, range, procedures, programs, contents, technical implementation and manufacturing documentation to be provided. This standard applies to pharmaceutical machinery (equipment) designed to confirm (DQ), guidance Operational Qualification (OQ) and Performance Qualification (PQ) work, Installation Qualification (IQ).