by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To establish a procedure for the safe, compliant, and documented disposal of expired finished goods in order to prevent unintended use, ensure environmental safety, and maintain regulatory compliance. 2.0 Scope This SOP applies to all expired, damaged, or...
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 13, 2025
GMP Audit Checklist – Process Validation 1. General Requirements Validation Master Plan (VMP) available, approved, and up to date. Validation activities aligned with regulatory guidelines (USFDA, EMA, WHO, ICH Q8–Q10). Validation performed for all critical processes...
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 lay down the procedure for operation, cleaning, and maintenance of the Cage Blender to ensure uniform mixing of powders and granules in compliance with cGMP. 2.0 Scope This SOP applies to the Cage Blender installed in the production area of [Company...
