QUALITY MANAGEMENT SYSTEM
Novatek Pharmaceuticals Ltd. believes in effectiveness of a quality system based on the principles of continuous improvement, progress and prevention as per the WHO recommended guidelines. We monitor and control each and every process of our manufacturing and quality control operations to ensure quality standards of our products.
Our QMS consists of Quality Assurance and Quality Control which are working independently. Quality assurance department is well-equipped with the most modern and sophisticated machineries and instruments including Atomic Absorption Spectrophotometer (AAS), High-performance Liquid Chromatography (HPLC) to ensure the best quality pharmaceutical finished products in strict compliance with the guidelines and specifications to accomplish and maintain a very high quality standard. We maintain strict quality control procedures at each and every step starting from source validation, sampling and analysis of the raw materials to appropriate documentation and manufacturing of finished products. People at all levels are committed to adopt the latest technology for continuous development as we believe that quality is a continuous process; and we always try to develop.
Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors relevant to quality assurance. The system of Quality Assurance and Quality Control appropriate for the manufacture of quality pharmaceutical products:
- Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP.
- Production and control operation are clearly specified and Good Manufacturing Practice adopted.
- Arrangements are made for the manufacturer, supply and use of the correct starting and packaging materials.
- All necessary controls on intermediate products, and any other in-process controls and validations are carried out.
We maintain self-inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance System. Quality Control is responsible for testing and analysis Active Pharmaceutical Ingredients, Excipients, Dosages Forms and Packaging Materials, Reagents Management of QC Laboratory, Management of Retention Sample, Reference Standard Management, preparation of testing instruction and batch release. Quality Assurance is responsible for Self-inspection, Policy preparation, Gap analysis, Validation, Personnel Training, Qualification, Ensure Data Integrity on site and also confirms quality system as per regulatory requirement.
