Quality Assurance & Quality Control

Biosira Ltd produces and sells products that save, extend and improve people's lives worldwide. The company is working to address social and environmental issues across the product life cycle, from bioethics and sustainable design during research and development, to efficient use of energy and materials during manufacturing and transport, to responsible product promotion, and finally, repair, refurbishment and recycling at the end of the product’s life. 

Quality and safety are imperatives across the product life cycle. Methods & Process Validation Regular Self-inspection, and Quality Audit form integral part of our Quality Management prerogative. Monitoring of Environment Controls within and outside manufacturing plants & Safety measures of our employee staff is the keystone of our safety management plan and forms the ‘Quality Bible’ of the company.  
 

Elaborate & Complete In-Process Control

 
Biosira Ltd Pharma firmly believes in the fact that Quality stems from an attitude of refusing to settle for the second best, leaving no room for compromise. The approach to Quality Control is total and integrated. 
 
Quality Control/Assurance checks at all stages of production commencing from bulk drugs including excepients to the finished formulations. Chemicals and biochemical tests like SDS PAGE, microbiological analysis testing like bacterial end toxins tests, instrumental analysis using highly sophisticated as well as modern instruments like HPLC, GC, UV, are conducted as per specified pharmacopeial criteria. 
 
“...quality isn’t something that can be argued into an article or promised into it. It must be a culture and must be one of the key ingredients of the manufacturing processes. Otherwise, the finest sales talk in the world won’t act as a substitute.” 
 

Full Fledged Quality Tools & Total Quality Control

 
Biosira Ltd's reputation is built on the quality of its products and services. Biosira Ltd's quality systems apply across the product life cycle, including design, development, manufacturing, sterilization, labeling, packaging, handling, distribution and promotion. 
 
To assess and facilitate compliance with applicable requirements, the company regularly assesses its quality systems and conducts quality management reviews to identify issues that may affect product and service quality. Biosira Ltd also assesses its suppliers of raw materials, components and finished goods. 
 
The dedicated Quality Control laboratory facilities at each manufacturing location is technologically advanced and supported by sophisticated analytical instruments such as FTIR & UV Visible Spectrophotometer, Disintegration Test Apparatus, Gas Chromatography, Potentiometer, Polarimeter, UV cabinet, Laminar Flow Station, Sterility Test unit, Dissolution Test Apparatus, High Performance Liquid, Chromatography (HPLC), Karl Fischer Titrator, PH meter, Refractometer, Incubators, Vacuum Ovens. 
 
The synchronization of QC processes, skillful technicians sophisticated analytical tools and quality assurance protocol ensures that every product quality not only meets but surpasses international standards. All QC Laboratories confirm to cGLP (current Good Laboratories Practices) in Total Quality Management. Achievement of this standard is manifestation of the highly systematic and documented work culture that we are committed to follow. The award of WHO-GMP certificate and submission to USFDA, TGA & UK MHRA quality norms in our manufacturing venture, further corroborates our quality commitment.