QUALITY
Our dedication to quality is not just a promise.
Quality Control and Quality Assurance at Denisco
At Denisco, our commitment to exceeding customer expectations and adhering to stringent international quality standards underscores our dedication to delivering exceptional products. With robust quality control facilities at every facet of our operations, from order processing to final shipment, is subject to meticulous monitoring to ensure the highest quality standards.
Continuous Quality Improvement
Our drive for performance excellence extends across our entire product portfolio, motivating us to constantly enhance our offerings in response to evolving market demands. Our experienced team is well-versed in the regulatory landscape, enabling us to proactively shape our policies in alignment with emerging legislation.
Rigorous Compliance
Our manufacturing, maintenance, and control processes adhere to the rigorous cGMP guidelines established by ICH (Q7) and the relevant requirements of ISO 9001:2015, ICH, FDA, EMEA, and EDQM.
Precision with Advanced Instruments
To uphold our commitment to quality, we employ a suite of high end analytical instruments. High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV Visible Spectrophotometer, Fourier Transform Infrared Spectroscopy (FTIR), and Stability Chambers are among the major tools we use to measure the quality of all our products. These instruments enable us to ensure consistency, accuracy, and reliability across our offerings.
We guarantee that every product leaving our facility meets the highest benchmarks of quality and performance.
Process
Denisco has separate areas for wet analysis, HPLC, GC, control samples, stability chambers, balance room, and Hotzone analysis. All the systems and processes are thoroughly supervised by our team to ensure the specification of products as per the customer demand. Self-inspection and self audit are routinely performed that the quality of our premises and equipments are in accordance with Schedule M and Schedule L.
The following is a snapshot of certain processes we follow at Denisco:
Sampling, testing, and dispensing of sterile materials as per the cGMP guidelines
Intermediate testing during production.
Analytical method development, validation, and transfer.
Maintaining equipment qualification and calibration program.
Stability testing to ensure the quality of all the products.
Product Validation
We at Denisco rely on the preparation, review, and approval of SOPs, protocols, and reports for producing a perfectly customized product.
We perform validation across all activities- product validation, development validation, vendor approvals, process validation, ensuring GMP compliance of the facility is the basic framework we do at Denisco.
