API Manufacturing Audits
Domestic and international Pharmaceutical Companies
Reviewed synthetic processes and developed audit plan to TGA and PIC/S requirements for assessing suitability to supply. Assessed and reported on facilities in Italy, Austria, Argentina, India and USA.
- Produced audit report on quality systems used in API manufacture.
- Provided risk assessment of strengths and weakness of operation.
Finished Product Manufacturing Audits
Pharmaceutical Company
Developed an audit plan to TGA and PIC/S requirements for assessing capability to manufacture. Assessed and reported on facilities in India.
- Produced audit report on quality systems used in manufacture.
- Provided risk assessment of strengths and weakness of operation.
Contract Laboratory Audits
Domestic and International Pharmaceutical Companies
Conducted vendor audits of contract research and testing laboratories to FDA, TGA and PIC/S requirements. Assessed and reported on facilities in UK, India, Canada and USA.
- Produced audit report on quality systems used in manufacture.
- Provided risk assessment of strengths and weakness of operation.
