A Review on Regulatory Authorities & Standards Institutions and Self Auditing Consideration in Pharmaceutical Industry
Soubin Roy1*, Santosh Dattu Navale1, Sumit Shivaji Misal1, Manmohan Padamsingh Negi1
1.Department of Formulation & Development Scientist, Intelliscend NDDR Thane (W), Maharashtra, India 400604
In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced auditors decades to develop. It follows the auditing guidance of ISO-19011 and is a virtual audit of a manufacturing facility that makes a range of dosage forms. This allows you to plan and prepare audits of the supplier and your own supplier audit system. Throughout the course, there is personal practice with exercises and teamwork’s in planning, preparation and performance that address WHO. The extensive of course notes and excellent lectures given by knowledgeable and professional tutors in pharmaceutical industry, The WHO was very easy to approach with any problems in during the course. The purpose of regulatory authorities to assess application for authorization to market products for human use and either grant authorizations to market each product or reject such applications and inspect the manufacturers and wholesalers of medicines for human use and either grant manufacturing and wholesale licenses or refuse such licenses. The international regulatory authorities under consideration are in this article WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM.
Keywords: Regulatory authority, WHO, Self-auditing, Standard institution