Temperature excursion management: A novel approach of quality system in pharmaceutical industry

Author:

Kumar Nirmal,Jha Ajeya

Publisher

Elsevier BV

Subject

Pharmaceutical Science,Pharmacology

Reference5 articles.

1. Adadevoh, K., 2002. Short-term, Freeze Thaw and Shipping Studies. ARMWG RFP11 Report.

2. The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products, 2007, Edition Two (1428 H – 2007G).

3. Degradation of pharmaceutical solids accelerated by changes in both relative humidity and temperature and combined storage temperature and storage relative humidity (T×h) design space for solid products;Porter;J. Valid. Technol.,2013

4. Troubleshooting during the manufacturing of lyophilized drug product – being prepared for the unexpected;Roy;Am. Pharm. Rev.,2012

5. Mean kinetic relative humidity: A new concept for assessing the impact of variable relative humidity on pharmaceuticals;Scrivens;Pharm. Technol.,2012

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