About Authors 1AGARWAL POONAM*, 2RATHORE KAMAL SINGH, VIJAY KAVITA2 1Department of Pharmaceutics, Bhupal Nobles’ College of Pharmacy Udaipur, Rajasthan, 2Faculty, Jaipur, College of Pharmacy, Jaipur India, 313001.
Email : charmiagarwal823@gmail.com
Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy. This has also resulted into stricter norms for Marketing Authorization (MA) and Good Manufacturing Practices (GMPs).
About Authors
Ms. Priti B. Savant,Ms. Ashwini R. Pawar, Ms. Kaufiya D. Sayyed , Ms. Pooja R. Yelmar
1,2,3,4 Sahyadri College of Pharmacy Methwade Tal, Sangola, Distsolapur Maharashtra 413307
About Authors
Avdesh Thassu,1* Chandra Mohan Nandi 2 1Associate Vice President
Global Regulatory Affairs,
Emami Limited, India 2 Deputy Manager,
Global Regulatory Affairs, Emami Limited, India
*athassu@hotmail.com
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).