Documentation

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, 1995, Vols. vol. 11, 171-174.

ISO 22514-1: 2009 – Statistical methods in process management – Capability and performance – Part 1: General principle and concepts