Good manufacturing practice guide for active pharmaceutical ingredients, ICH Q7, Current Step 4 version, dated 10 November 2000 Pharmaceutical Quality System, ICH Q10, Current Step 4 version, dated 4 June 2008 Chapter 1 of the EU GMP Guide, January 2006. An alternative method to test for randomness of a process. Holmes, Donald S. s.l. : Quality and reliability engineering international,...Read More
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