We believe that the foremost aspect for any pharmaceutical manufacturing company comprises of a comprehensive documentation and auditing by means of ‘Total Quality Management’. Hence, at Gylus Pharmaceuticals we assure that throughout every single phase of manufacturing process, right from acquisition of raw materials, full documentation and continual auditing is conducted to ensure that all the instituted protocols are duly substantiated. This in turn guarantees manufacture of superior quality pharmaceutical products with elongated shelf life and which are in accordance with the internationally accepted Pharma Industry Standards for quality, purity, value and safety.
The facility has a comprehensive Chemical, Instrumentation, Microbiology and Sterility Laboratories provided with Class 10000 environment and SS horizontal Laminar Air Flow Units. Complete spectrum of microbiological and sterility validation tests are conducted for perpetual microbiological monitoring of all processes, products as well as personnel and production areas, in order to safeguard absolute purity of products.
The Quality Assurance Department administered by professionally competent and highly experienced technical team and supported by meticulous and innovative analytical equipments emphasises on:-
Regular validation of Products, Processes and Test Methods;
Systematic calibration of all instruments to consistently guarantee superior quality production output;
Conducting quality audit and validation by external agencies on regular basis;
Repeated monitoring of approval of vendors based on stringent procedures set forth;
Frequent up gradation of analytical facilities;
Consistent up gradation of manufacturing facilities to meet latest GMP requirements;
Persistent training to improve the professional skills of personnel.
In conclusion, quality analysis is performed and duly documented for everything, right from raw material, packing material, in process control, finished products, stability, validation, microbiology and traceability.