Based in Sydney Australia, Parnell’s 30,000ft² manufacturing facility is among the finest in the world. Industry-best quality and manufacturing standards are the foundation of Parnell’s manufacturing performance, and are exemplified through our employees and Parnell’s rigorous Quality Management System. Parnell’s facility has ample available capacity with many highly sought after capabilities:
- Manufacture of aseptically filled and terminally sterilized injectable drugs, including drugs containing highly potent actives.
- Automated manufacture of 10mL – 100mL glass vials using single-use manufacturing technology, semi-automated manufacture of plastic vials.
- Flexible batch size range from 10L to 1000L suitable for clinical trial materials to commercial campaign manufacture.
- Non-sterile manufacture of powders pastes and medicated soft chews.
- Approved for aseptic fill and terminally sterilized manufacture by FDA, EMA (PIC/S) and APVMA.
- Full Chemistry laboratories, Microbiology laboratories, R&D laboratories and Stability Rooms capable of conducting trials from 2°-8°C to 40°C.
- Temperature controlled warehouses ranging from 2°C to 8°C to below 25°C.
For more information concerning our contract manufacturing capabilities, please email [email protected] with your name, company and any questions.
Parnell’s Quality Philosophy
- Parnell views quality as the cumulative value added to our products throughout each stage of our manufacturing process.
- At Parnell, quality is not simply a function, it is a core company value and ongoing expectation held by all employees, singularly focused on delivering only the very best pharmaceutical solutions.
- This philosophy is exemplified by our rigorous Quality Management System (QMS), which ensures the quality of our products identity, strength, purity, and efficacy.
Full development services available: R&D, Clinical Studies, Stability, Small/Medium volume manufacturer.
Currently capable to manage batch sizes from 10L, 40L to 200L and by 2017 up to 1,000 liter batch sizes.
Currently have the ability to manufacture vials sizes ranging from 10mL to 100mL.
Robust manufacturing processes, environmental monitoring and sterility testing assurance programs that maintain the highest regulatory standards for manufacture of quality products across the US, Europe and Asia Pacific markets.
Introducing Single Use Systems technology to further increase productivity.
Lean manufacturing framework focusing on continuous improvement, product quality, and customer satisfaction.
2010- APVMA approval for Asia Pacific & Canada manufacture.
2013- FDA approval for USA manufacture.
2015- TGA inspected and approved for manufacture across the EU.
2015- Successful FDA audit.
2016- Parnell announces first contract manufacturing agreement.