Pharma Paper’s Q&A On New GMP Implementation
This article was originally published in PharmAsia News
Executive Summary
With regard to China’s new GMP guidelines, electronic data should be up-to-date, traceable, accurate, printable, password-protected, handled and checked only by authorized staff, and should contain legal electronic signatures.
With regard to China’s new GMP guidelines, electronic data should be up-to-date, traceable, accurate, printable, password-protected, handled and checked only by authorized staff, and should contain legal electronic signatures. Every A-level sampling point’s sampling amount should be over one cubic meter, whose clean area monitoring should adopt 28.3-liter sensors, be ventilated, and be sufficiently frequent for timely error detection. The air purification system of clean areas for sterile drug production should be ongoing. The pressure difference between core critical areas and other areas should be at least 10Pa. (Click Here For More - Chinese Language
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"Q&A On New Pharma GMP Implementation (Episode 6)"- news.40777.cn (10/23/2012)