by Dr. Yashashwini Reddy | Sep 13, 2025
Regulatory Affairs Audit Checklist 1. Regulatory Submissions & Approvals Dossier submissions (CTD/eCTD/ACTD) prepared and archived properly. Records of Marketing Authorization Applications (MAA), IND, NDA, ANDA, DMF, CEP maintained. Approval letters from health...
by Dr. Yashashwini Reddy | Sep 13, 2025
Warehouse Audit Checklist 1. General Warehouse Practices SOPs available and followed for receipt, storage, dispensing, and distribution. Warehouse access restricted to authorized personnel. Cleanliness and housekeeping maintained as per GMP. Pest control records...
by Dr. Yashashwini Reddy | Sep 13, 2025
HR Audit Checklist 1. Recruitment & Selection Existence of recruitment policies and SOPs. Proper manpower requisition approvals before hiring. Background verification and reference checks of employees. Job descriptions and competency requirements documented....
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Data Falsification in the Pharmaceutical Industry Definition:Data falsification is the intentional alteration, manipulation, or fabrication of data in order to misrepresent results and meet regulatory, quality, or business expectations. It is one of the most serious...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Regulatory Compliance in Pharmaceuticals: 8 Common Mistakes and How to Avoid Them Definition:Regulatory compliance in pharmaceuticals means adhering to laws, regulations, and guidelines (e.g., US FDA, EMA, WHO, MHRA, CDSCO) to ensure medicines are safe, effective,...
