Stability Studies of Pharmaceutical & Cosmetic Products

The purpose of stability testing is to provide evidence on how the quality of an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions. The design of the stability-testing programme should take into account the intended market and the climatic conditions in the area in which the medicinal products will be used. The stability testing recommendations in this guideline cover the long-term storage condition for all Climatic Zones, i.e. I – IV. The shelf life should be established with due regard to the climatic zone(s) in which the products are to be marketed. For certain preparations, the shelf-life can be guaranteed only if specific storage instructions are complied with. Contents of book include: Chapter 1: Regulatory requirements for stability studies Chapter 2: Factors affecting stability of pharmaceutical and cosmetic products Chapter 3: Development of stability indicating methods Chapter 4: Stability studies guidelines for pharmaceutical products Chapter 5: IPEC excipients stability guidelines Chapter 6: Stability testing of biological, biotechnological products Chapter 7: Stability of cosmetic products Shri. P.P. Sharma is B.Pharm (BITS, Pilani) and M.Pharm (Punjab University). He has been Rank Holder both at Graduate Level and Post Graduate Level and was awarded Gold Medal by Punjab University. After a short stint with Pharmaceutical Industry, he joined Drugs Control Dept. of Delhi Govt. where he worked in various capacities and retired as Dy. Drugs Controller and Licensing Authority. During his Professional career he had opportunities for training by Govt. of India and International Bodies like WHO and DANIDA. His approach to enforcement of law was ‘enforcement by education’ and this led him to write books. He has 06 books to his credit. He is faculty to various training programmes of Govt. of India and guest faculty to several pharmacy educational institutions