GB/Z 42344-2023
ActiveVerify guidance for computerized system of pharmaceutical machinery (equipment)
制药机械（设备）计算机化系统验证指南
Application Summary AI generated
This standard provides guidance for validating computerized systems integrated into pharmaceutical machinery and equipment. It is applied by pharmaceutical manufacturers and equipment suppliers to ensure that automated systems controlling production, packaging, and quality testing meet regulatory requirements for data integrity and process reliability. The guidance covers the entire validation lifecycle, from design and installation to operation and performance qualification, specifically within Good Manufacturing Practice (GMP) contexts.
Related Standards
NY 5071-2002
Pollution-free Food - Guidelines for the Use of Fishery Drugs
GB/T 19618-2004
The licorice
GB/Z 42246-2022
Nanotechnologies—Guideline on genotoxicity test methods for nanomaterials
GB/Z 42540-2023
Technical guide for containment of pharmaceutical equipment—Solid preparations
GB/T 19116-2003
Lycium culture technics operatings
GB/T 15692.6-1995
Terms of pharmaceutical machinery--Water treatmet eqiupment for pharmaceutical use
GB/T 15692.9-1995
Terms of pharmaceutical machinery--Other pharmaceu-tical machinery and equipment
GB/T 15692.7-1995
Terms of pharmaceutical machinery--Pharmaceutical packaging machinery
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.