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Quality

Bio Pharma’s commitment to high quality is without compromise.

Its quality assurance and quality control department meet the highest Australian and international requirements.

Quality Control Department

The quality control department has quality control laboratories existing at each production side. The laboratories undertake a wide range of tests and analysis of raw materials, intermediates and finished products according to written procedures and test methods to ensure compliance of all materials to the established and documented specifications. All testing is well documented and the testing records are kept for further references.

The team working in Bio Pharma’s laboratories is composed of professional and well trained people.

Quality Assurance Department

The quality assurance department is in charge of Bio Pharma’s quality assurance (QA) system. QA system that is in place has been custom built for Bio Pharma and is in accordance with Food and Drug Administration (FDA) / Therapeutic Goods Administration (TGA) and current Good Manufacturing Practice (cGMP) guidelines.

All production and quality control testing is done according to prepared and approved procedures. All relevant production and testing records are generated during the actual production or analytical testing and they are carefully reviewed by quality assurance personnel before approval is granted for dispatch.

The quality assurance department ensures the ongoing compliance of Bio Pharma’s quality assurance system with Australian and international regulatory authorities’ cGMP requirements as well as continuous in-house quality improvement by ongoing training of its employees.

The accreditation by TGA is scheduled for this year and accreditation by FDA is planned in 2009.

P.O.Box 194,  Coopers Plains QLD 4108    Australia

E-mail: office@biopharma.com.au