Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible.
This presentation will discuss this concept, which has been applied to sterility testing of terminally sterilized products and has become associated with parametric release applications.
Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT). This presentation addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing.
Vipul Doshi is the President Global Quality Assurance, International Regulatory Affairs, Pharmacovigilance, EHS and API R&D in Cadila Healthcare Limited (CHL) at Ahmedabad. Mr. Vipul Doshi has joined Zydus group about 4 years ago to head Quality and Regulatory function at Global level.
He has distinguished career of over 30 years in reputed Pharmaceutical Industries in India and helped Industry to benefit from his expertise in his chosen field. He has developed motivated teams wherever he has worked, and has been a good trainer, guide and motivator to all those who have worked with him.