Chinese Good Manufacturing Practices for Drugs, 10/10

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The 2010 revision of Good Manufacturing Practices for Drugs was adopted by the Chinese Ministry of Health on October 11, 2010.ﾠThis document from the State Food and Drug Administration of the P. R. China went into effect on March 01, 2011.

Chapters and Articles within this GMP document address the requirements for the use of computerized systems within manufacturing:

• Chapter 7:  validation and qualification
• Article 109:  computerized storage systems
• Article 163:  electronic documentation management
• Article 211:  electronic code readers and counters
• Article 241:  change control for computer software