Module 3 2019

References and Further reading

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ICH Stability Guidelines: Q1A-F

• WHO Annex 10, Stability testing of active pharmaceutical ingredients and finished pharmaceutical products https://extranet.who.int/prequal/sites/default/files/documents/TRS1010_Annex10.pdf

• Drug-Excipient Interactions: Pharm Technology Europe: Crowley P, Martini LG:; 2001 13 (3) 26-34

The Organisation for Professionals in Regulatory Affairs