Stability testing of pharmaceutical products

World Health Organization (WHO) (2001), Stability testing of pharmaceutical products containing well established drug substances in conventional dosage form, WHO Technical Report Series 863, Annex 5, WHO, Geneva. 

An underlying assumption of the Arrhenius equation is that the reaction mechanism does not change as a function of temperature. Since accelerated stability testing of pharmaceutical products normally employs a narrow range of temperature, it is often difficult to detect nonlinearity in the Arrhenius plot from experimental data, even though such nonlinearity is expected from the reaction mechanism [7]. 

Change of product shelf life Major Stability data to support the new shelf life. Please refer to the Guidelines to Stability Testing of Pharmaceutical Products (Annex B of Guide to Product Licence) C22(i)... 

Good Manufacturing Practices for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional... 

Kopp S. 2006. Stability testing of pharmaceutical products in a global environment. Regul Aff J 16(5) 291-294, http //www.who.int/medicines/areas/quality.safety/quality.assurance/ RAJ2006WHOStabmty.pdf... 

The Arab Union of the Manufacturers of Pharmaceutical and Medical Appliances (AUPAM) 1995 (updated in 2002). Arab Guidehnes on Stability Testing of Pharmaceutical Products... 

Matsuo M, Machida Y, Furuichi H, Nakamura K, Takeda Y. Suitability of photon sources for photostability testing of pharmaceutical products. Drug Stability 1996 1 179-187. 

ICH Expert Working Group, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. 

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Notice Stability testing of new drug substances and products Stability testing Stability testing... 

CE methods are developed and utilized in pharmaceutical QC for early to late phases of drug development. Chapter 4 covers the approaches for late-phase development for small molecules that can be used in early-phase development, as well as for large-molecular-weight compounds. Late-phase method development in pharmaceutical QC is performed for required stability studies and for release of the drug product or drug substance validation batches, and is intended to be transferred to the operational QC laboratories for release testing of the production batches. Preferably, late-phase methods should be fast, robust, reliable, and transferable. Therefore it is crucial to devote adequate time, thought, and resources to the development of such methods. 

IFAMA (2003), ICH stability testing of new drug substances and products, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva. 

Blythe (32) made a survey of the stability practices of 40 pharmaceutical companies. He found that a majority used exaggerated conditions of temperature, humidity, and light to test the stability of pharmaceutical products. Correlations of the data obtained with that of shelf-life data differed considerably. 

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