The Quality Assurance Department has responsibility and authority to define norms and regulations for various activities including personnel training, sanitization and cleaning of general areas. Quality Assurance Department reviews the production records to ensure that all the manufacturing operations are carried out as per the laid down instructions. Quality Assurance Department ensures that all production facilities are provided to meet cGMP requirements and have adequately trained and qualified persons to carry out the operations. All manufacturing operations are clearly defined and checked routinely to confirm the quality of products.

Quality Control department is independent of Production and other departments, with an authority to “approve” or “reject” starting materials, packaging materials and intermediate and semi-finished products. Quality control department have facility for chemical, physicochemical, instrumental & Microbiological testing of raw materials, packaging materials, in-process, intermediate materials and finished products.

Adequate facilities, trained & competent personnel and approved procedures for sampling and testing of starting materials, packaging materials, in-process, intermediate materials and finished products are established to ensure that all quality control procedures are effectively and reliably carried out. Records of inspection lot and testing of materials are maintained.

Test certificates are generated for the products tested with reference to approved specification and maintained as per GMP requirements. Sufficient samples of starting materials are retained to permit future examination of a product, if required. Instruments used for analysis are calibrated and qualified for its intended use. Calibration calendar and Validation Master Plan exists for quality control laboratory, giving provision for re-qualification as and when required. In-process testing is performed to ensure all manufacturing processes proceed in accordance with predefined specification. Finished products are tested using validated analytical methods, as applicable to ensure that all products comply with predefined specifications.

Procedures are available to monitor and to derive the trend analysis of water quality and the environmental control for different areas. All personnel working in the laboratory are subjected to training on recruitment and also qualified for specific area of testing. Well-defined procedure for OOS and OOT (Out of Specification and Out of Trend) exists for detail investigation of product failures. Pharmacopoeias, reference standards, working standards, reference spectra, other reference materials and technical books are available in quality control unit. Stability studies of all products are carried out as per respective SOPs and applicable regulatory guidelines.

 

The Quality Management System

“Quality Policy” of the firm is Naxcure Healthcare Private Limited (NHPL), aims at being a responsive quality supplier of pharmaceutical products in compliance with the current guidelines of Good Manufacturing Practice (GMP). We take pride in developing and sustaining matchless level of Quality in manufacturing of Drug formulations in order to meet customer and consumer satisfaction.

Improving a quality mindset is a continuous process with the involvement of every employee. Quality understanding and competency will be secured through a comprehensive training system. The use of quality indicators (KPIs) and regular quality meetings at a management level will contribute to satisfactory attention and corrective actions. Use of quality risk management by valuing the product quality and the patient safety is an important tool and an integral part of our quality culture.

Naxcure’s Management focuses on Total Quality Management System in Designing, Maintaining, Assessing, Improving and Building an overall Quality assurance at every step of Operations to materializes its philosophy to ensure the highest level of quality healthcare services in favor of Mankind. Our customers shall perceive us as agile with respect to working processes and the way we operate and interact.