To ensure effective implementation of quality control procedures, the Quality Control department is offered a high degree of autonomy. This authority vested in the department enables only them to approve or reject, raw and packing materials and bulk and finished products.
As a firm certified in WHO-GMP, Rusoma has developed a comprehensive quality management system. This comprises effective quality assurance procedures in accordance with the schedule-M of The Drug and Cosmetics Act, 1940 and Rules, 1945, WHO-TRS and PIC/S guidelines.
Good manufacturing practices (GMPs) are indispensable for the development of reliable and quality pharmaceutical products. At Rusoma, these include:
- Compliance of WHO-GMP requirements during all manufacturing activities to ensure safety, quality and efficacy of products
- Extensive training and testing for all individuals
- A separate department for regular documentation, creation of in-process controls, training and proper systems implementation
- Release of finished products for distribution allowed only after a comprehensive analysis by the Quality Control Department and approval from Quality Assurance
- The use of only approved raw and packing materials in the production process with the materials released only after thorough tests as per their specifications
- Rigorous supervision by competent technical staff during manufacturing and packing activities
The creation of change control systems to track facility, equipment and process changes
- Maintenance of a Validation Policy and a Validation Master Plan to ensure the validated state of the facility, equipment and processes
- Self-inspection procedures made available to monitor effectiveness and applicability of the quality systems
- Regular stability studies carried out as per ICH and WHO Guidelines
Scientific Testing and Excellence
- Chemical Analysis
These tests are implemented on RM, bulk samples, water and finished products, and involve the right use of several instruments like HPLC, UV spectrophotometer, etc.
- Bacterial Endotoxin Testing (BET)
Performed to detect bacterial endotoxin in the product, this test is presently carried out using the Limulus Amebocyte Lysate (LAL) kit
- Sterility Testing
A test that ensures the sterility of finished products, it utilizes the membrane filtration method and need 14 days incubation time for terminally sterilized products.
- Stability Testing
A real-time stability test performed on finished product batches by keeping them at controlled room temperature.
The Quality Control lab is equipped with more than 50 sophisticated instruments. Our team procures the best-in-class instruments like the Agilent UHPLC, Agilent FTIR, GE- TOC, Shimadzu- Spectrophotometer, PAMAS Liquid Particle Counter, Hi-Media Air sampler, etc. The high-end quality of our equipment is complemented by stability studies that are carried out in the futuristic Newtronic stability chambers which are CFR 21 Part 11 compliant.
A separate area is reserved for the BET test while microbiological operations and sterility testing is performed under Grade-A environment surrounded by Grade-B environment.