Regulatory Filings and Life Cycle Management of Aerosols and Nasal Sprays in Asean Latam And Europe Prakash Lalan Mishra

Abstract

The Formulation and Drug delivery device together makes Aerosol and Nasal spray more complex unit. Markets which are taken into consideration are ASEAN, LATAM and Europe for comparison purposes at times. The quality part is a big challenge while submission of dossier for Aerosol and Nasal spray in studied countries. For Aerosol quality tests are important to conduct at the stage of development and during the manufacturing as well. It is difficult to maintain quality throughout its shelf life because of complexity of the dosage form. The US and Europe have established guidelines for the quality and clinical requirements while other developing markets lack to some extent. On the other hand, Life Cycle Management of the product is also important in order to maintain the quality and research and innovation of the aerosol and nasal spray product. Generally all the markets have variation guidelines in order to register any kind of change or alteration in the process or product. Any change which is supposed to be registered with the regulatory authority in ASEAN market has to go through the ASEAN guidelines for variation and all the required documentation are provided according to that in the prescribed format. Countries like Bolivia have country specific or customer specific requirements for submission of dossier for any product. Furthermore, regulatory requirements for dossier submission for 2 countries are studied. Additional to that, various case studies associated to change control and variations are given respectively. In one case, the changes are not at all serious or which could be major affect the quality of the product and another case where there could major effects on the quality of the product for which a variation is to be filed with the regulatory agency of the country.