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 marke...

Drug information is something that is needed by all pharma professionals whether in practice, industry, pharmacy education or regulatory. Drug information in this title has been compiled based on their use in disorders of different body systems like gastro-intestinal tract (GIT), respiratory tract, cardio-vascular system. In the introductory section of each part, there is general discussion on different classes of drugs, which are used in the treatment of disorders of the system. Later, th...

The first edition of this book was well received by the pharmaceutical industry and pharmacy education institutions. Over the years, since this book was published, there have been some changes e.g. acceptance limits in media fill trials, acceptance limits in cleaning validation. Thus, there was a need for review of this book.In the first edition, process validation, in general, was discussed and then some special processes were discussed. But validation of packaging process was not ...