Quality Assurance and Regulatory Compliance for Pharmaceutical Product文档.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * Quality Assurance in Life Cycle Management Post approval changes Reporting Level 1 ? Annual Report Level 2 Changes Being Effected (CBE) Changes Being Effected in 30 days (CBE-30) Level 3 Scale-Up and Post-Approval Changes Changes Being Effected (CBE) Changes Being Effected in 30 days (CBE-30) Prior Approval Supplement (PAS) Post Approval Changes (US SUPAC) 04th Oct. 2011 * Maharashtra College of Pharmacy, Nilanga Quality Assurance in Life Cycle Management Category Reporting Minor Type 1A Moderate Type 1B Major Type II standard Critical