Quality

Quality

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.

State-Of-The-Art Equipment

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.