Regulatory Requirements and Life Cycle Management of Parenteral Products In Asean Countries

Abstract

There are different markets in the world. Some are having so much regulations and guidelines for the parenteral product registration where some countries are having less rules and regulations as compare to the regulated markets and some are the countries still trying to implements the rules for the registration and approval. In all that USA, Europe are the most stringent and highly regulated market. Where other countries comes under ROW Market but under the ROW market also there are some regions like CIS Region, ASEAN region, South Africa Region. In this Project discussed about all the requirements and the regulation of ASEAN countries. There are 10 countries in the ASEAN region all the country wise rules, regulations and the Registration as well as approval process. Comparative study of the all the countries which are following ASEAN CTD so their administrative documents, technical documents as well as non-clinical and clinical documents. Only three countries of the ASEAN region are following their own regional specific format. Other than that the life cycle management of parenteral product so information from the manufacturing, evaluation tests to the change control, variation and post approval maintenance. Taking example of Heparin sodium injection BP so the manufacturing process for heparin injection, different evaluation tests as well as the whole dossier of heparin sodium injection in ACTD format it’s queries, and the Variations are discussed here.