Review of the PIC/S GMP Annex 1 Interpretation
There are two sections within the PIC/S document, GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS (PI 032-2), issued January 2010, which require further clarification from an industry perspective. Section 6 and Section 11 both speak to particle counter performance and tubing length. A review of these two sections is discussed.
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