Quality Control Department

The Quality Control (QC) Department serves as the scientific gatekeeper of product quality at Nivix Pharmaceuticals Limited. Our QC analysts and microbiologists are responsible for testing raw materials, in-process samples, finished products, and environmental monitoring samples to verify compliance with established specifications and pharmacopoeial standards.

QC operates independently from Production, with authority to approve or reject materials and products based on analytical results. Our testing capabilities include chemical, physical, microbiological, and instrumental analyses, supported by validated methods and calibrated equipment maintained under a documented calibration programme.

Every test is performed according to approved specifications and standard test procedures, with results recorded in laboratory notebooks and validated LIMS or paper-based systems as applicable. Out-of-specification (OOS) and out-of-trend (OOT) results are investigated thoroughly in accordance with established protocols, ensuring that no compromised product reaches the market.

The department also manages reference standards, reagents, culture media, and retention samples in compliance with regulatory requirements. Stability studies — both ongoing and accelerated — are conducted to support shelf-life claims and ongoing product quality assurance.

Quality Control at Nivix is built on precision, integrity, and accountability. Our commitment is unwavering: to provide accurate, reliable, and timely analytical data that protects patients and upholds the reputation of every Nivix product.