Pharmaceutical Packaging Professionals (PPP) Pty Ltd provides cGMP finished product manufacturing, labelling, packaging, warehousing and distribution services (cold chain and ambient) for companies and research institutes undertaking clinical trials.
PPP manufacturing and warehousing facilities in Melbourne manufacture, warehouse and distribute clinical supplies for use in Australia, New Zealand, Asia and North America.
The Melbourne facilities have been purpose built to enable handling of the diverse range of drug substances and drug products that enter clinical development. Both facilities are TGA licensed to Manufacture Therapeutic Goods for Clinical Trials and hold relevant state Drugs, Poisons and Controlled Substances Licences.
The PPP facilities are conveniently located in Port Melbourne with close proximity to many major teaching hospitals, clinical sites and airports.
PPP has a history of providing high quality and cost-effective services in compliance with current Good Manufacturing Practice. The company has strong relationships in the pharmaceutical industry and research communities. Our knowledge and experience in drug development means we can deliver a tailored solution for your investigational product manufacturing, warehousing and distribution requirements.
PPP has been in operation since 2008 manufacturing non-sterile clinical supplies for phase 1 onwards. In addition, PPP operate a dedicated aseptic compounding suite for phase 1 supplies and conduct labeling, secondary packaging and release for supply of sterile dosage forms. Further details, including manufacturing steps are detailed in the TGA licence provided in the quality section.
We work locally and internationally on investigator and pharmaceutical industry initiated clinical studies. We look forward to the possibility of supplying your investigational product and/or meeting your logistics needs for your next study.
Telephone: +61 3 9673 1003
David has 20 years experience in the development and manufacture of pharmaceuticals including capsules, tablets, transdermal and dry powder for inhalation. This includes manufacture of commercial APIs at an FDA inspected facility and the development and manufacture of investigational products at facilities inspected by MHRA and TGA. David has implemented Quality Management Systems at several facilities resulting in Competent Authority licensing and has audited manufacturing facilities in Asia-Pacific, Europe and North America. Regulatory experience includes the coordination of CMC submissions to FDA, Health Canada and MHRA in support of clinical trials. David has a BSc joint honours degree in Chemistry and Biochemistry and has attended GMP & CMC training in Europe, US and Australia.
Telephone: +61 3 9673 1004
The Pharmaceutical Packaging Professionals Pty Ltd facilities in Port Melbourne are TGA licensed for the manufacture of Therapeutic Goods for Clinical Trials. Dosage forms and manufacturing steps are indicated in the attached Licence and Certificate of GMP Compliance.
Licence to Manufacture Therapeutic Goods
Certificate of GMP Compliance of a Manufacturer
Supplied on Request
Pharmaceutical Packaging Professionals Pty Ltd holds the appropriate Victorian Drugs Poisons and controlled substances licences.