by Dr. Yashashwini Reddy | Sep 8, 2025
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals Data integrity is not only about systems and SOPs, but also about people’s mindset, culture, and daily behaviors. Even the best electronic systems and QMS can fail if employees lack the...
by Dr. Yashashwini Reddy | Sep 8, 2025
Key Purposes of Change Control in Pharmaceuticals Change control is a critical element of the Quality Management System (QMS) in the pharmaceutical industry. It ensures that all changes affecting processes, equipment, materials, and documents are evaluated,...
by Dr. Yashashwini Reddy | Sep 6, 2025
1.0 Purpose To lay down the procedure for the safe, secure, and documented transfer of finished goods from the production/packing area to the bonded store room under controlled conditions to ensure compliance with regulatory and company requirements. 2.0 Scope This...
by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To establish a procedure for the operation, cleaning, and maintenance of the Saizoner Mixer Granulator to ensure uniform wet granulation in compliance with cGMP requirements. 2.0 Scope This SOP applies to the Saizoner Mixer Granulator installed in the...
by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To define the procedure for operation, cleaning, and maintenance of the Vibro Sifter used in production to ensure efficient sieving of raw materials and granules as per cGMP requirements. 2.0 Scope This SOP applies to the Vibro Sifter installed in the...
