by Dr. Yashashwini Reddy | Sep 6, 2025
10 Step Guide to cGMP Certification cGMP (Current Good Manufacturing Practices) certification demonstrates that a company’s facilities, processes, and quality systems comply with international regulatory standards (FDA, EMA, WHO, PIC/S). It assures product quality,...
by Dr. Yashashwini Reddy | Sep 6, 2025
How to Review GMP Documents Like a Pro 1. Understand the Purpose of the Document Identify the type: SOP, Batch Manufacturing Record (BMR), Protocol, Validation Report, Logbook, etc. Ask: What is this document supposed to control, guide, or prove? 2. Verify Structure...
by Dr. Yashashwini Reddy | Sep 6, 2025
Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Current Good Manufacturing Practices (cGMP) are the regulatory standards enforced by agencies like the USFDA, WHO, and EMA to ensure that pharmaceutical products are consistently produced and...
by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To describe the procedure for the operation, cleaning, and maintenance of the Multimill to ensure consistent performance and compliance with cGMP requirements. 2.0 Scope This SOP applies to the Multimill installed in the production area of [Company Name],...
by Dr. Yashashwini Reddy | Sep 3, 2025
Building Better Manufacturing Facilities in Pharmaceuticals Pharmaceutical manufacturing facilities must be designed to ensure product quality, patient safety, and regulatory compliance. A “better” facility goes beyond infrastructure—it integrates technology,...
