Quality Control

Stringent Quality Standards

As a WHO-GMP & ISO 9001:2015 certified company, Rusoma has developed a comprehensive quality management system. This comprises effective quality control procedures in accordance with the schedule-M of The Drug & Cosmetics Act, 1940 & Rules, 1945, WHO Technical Report Series (TRS) & PIC/S guidelines.

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 & Packing Materials” as well as “Bulk & Finished Products”.

Good Manufacturing Practices

Good Manufacturing Practices (GMPs) are indispensable for the development of reliable & quality pharmaceutical products. At Rusoma, these include:

Compliance of WHO-GMP requirements during all manufacturing activities to ensure safety, quality & efficacy of products.
Extensive training & testing for all individuals.
A separate department for regular documentation, creation of in-process controls, training & proper systems implementation.
Release of finished products for distribution allowed only after a comprehensive analysis by the Quality Control Department & approval from Quality Assurance.
The use of only approved raw & 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 & packing activities. The creation of change control systems to track facility, equipment & process changes.
Maintenance of a Validation Policy & a Validation Master Plan to ensure the validated state of the facility, equipment & processes.
Self-inspection procedures made available to monitor effectiveness & applicability of the quality systems.
Regular stability studies carried out as per ICH & WHO Guidelines.

Scientific Testing & 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 Equipments

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.