Comprehensive Testing of Medicine & Method Validation for Quality Assurance
The Central Drugs Standard Control Organization (CDSCO) strives to maintain accountability, transparency, and uniformity in its services to ensure all the medical products manufactured, distributed, and imported in India are safe and of the highest quality.
The Drugs and Cosmetics Act under the CDSCO lays down stringent standards for testing of medicine in the country. Nationally recognized laboratories such as that of Glarc constantly work upon meeting the standards and testing as per the standard methodologies.
Testing of medicine
At Glarc, our expert team conducts analytical testing with thorough consulting, training, and accuracy. All our tests are carried out at our accredited laboratory in the capital city of India.
Our comprehensive range of testing services include:
- Identification
- Assay
- Content uniformity
- Physicochemical testing
- Microbiological analysis
- Sterility testing
- BET
- Particulate matter
- Extractable leachable analysis
- Testing of method validation
Testing for stability
Stability testing is important for medicines. It offers real-time data that shows how a drug responds under the influence of environmental elements like light, temperature, and humidity under intermediate, long, and accelerate storage conditions.
We conduct stability tests while carrying outtesting of medicine to determine the shelf life of the medicine. Our stability studies comply with ICH guidelines for pharmaceutical products and new drug substances.
Testing of method validation
It is important to validate analytical protocols that pharmaceutical companies use. This helps to decide whether the products are suitable for the analysis. Our team at Glarc excels in testing of method validation, especially in microbiological and chemical methods. We are skilled to assist pharmaceutical industry with the process of planning and preparing protocols and doing a complete analytical testing for accuracy and validation.
We specialize in:
- Stability testing under ICG guidelines
- Method validation
- Product formulation methodologies
- Dissolution profile studies
Under the Drugs & Cosmetics Act, 1940 and 1945, the central and state regulators are responsible for the regulation of drugs and cosmetics. The regulatory policies envisage uniform implementation of the Act to ensure that the rights of the patients are protected and to promote their well being. At the same time, testing of medicine ensures that manufacturers comply by the standards and bring out high quality drugs in the market.
So, if you are a manufacturer, distributor, or exporter of medicines in India, contact our team at Glarc and partner with us and see how this can benefit your organization. We are one of the most trusted services for analytical testing in the field of medicine, food, water, environment, chemicals, and packaging.