by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To describe the procedure for proper cleaning, maintenance, and storage of sampling equipment used for raw materials, intermediates, and finished products to avoid contamination, cross-contamination, and ensure equipment integrity. 2.0 Scope This SOP...
by Dr. Yashashwini Reddy | Sep 15, 2025
📘 Guidelines for Preparation of Site Master File (SMF) The Site Master File (SMF) is a regulatory document that provides detailed information about a pharmaceutical manufacturing site, operations, and quality management system. It is required by WHO, EU GMP (Annex...
by Dr. Yashashwini Reddy | Sep 15, 2025
Audit Trail Requirements in Pharmaceuticals An audit trail is a secure, computer-generated, time-stamped record that allows for the reconstruction of events related to the creation, modification, or deletion of electronic data. In the pharmaceutical industry, audit...
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 8, 2025
7 Steps for Monitoring Compliance in Pharmaceuticals 1. Establish a Robust Quality Management System (QMS) Build SOPs, policies, and guidelines aligned with FDA, EMA, and ICH standards. Ensure document control and version management. 2. Conduct Regular Internal Audits...
