Chinese Good Supply Practice for Pharmaceutical Products, 1/13

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Good Supply Practice for Pharmaceutical Products was adopted by the Chinese Ministry of Health on January 22, 2013. ﾠThis document from the Chinese Food and Drug Administration went into effect on June 01, 2013.

Chapters and Articles within this GDP document address the requirements for the use of computerized systems within the supply chain:

• Articles 7, 124:  include use of suitable computer systems in the quality management system
• Articles 17, 126:  require the Quality Department to set quality controls and examine quality data within computer systems
• Articles 36, 138:  require the QMS to include management of computer systems and execution of electronic drug supervision
• Articles 40, 144:  require computer system log-in, records of data modifications, and quality management review of data modifications
• Article 57:  requires computer systems that manage quality control, quality traceability, and electronic drug supervision
• Article 58:  defines the components of a computer system as servers, terminals, a safe and stable network, LAN, printing capabilities, database, and application software
• Article 59:  requires procedures, authorization, and management to ensure data originality, authenticity, accuracy, security, and traceability
• Articles 60, 145:  require daily back-ups and storage in a secure place
• Article 76:  provides requirements for use of electronically transmitted inspection reports
• Articles 81, 82, 84, 102, 149, 161, 176:  set requirements for electronic supervision of drugs
• Articles 86, 87, 89:  set requirements for computer systems used in drug storage