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.
Chief Executive Officer Craig is a registered pharmacist, toxicologist and holds a bachelor of law. Craig has over 20 years of experience working within the pharmaceutical industry including management of FDA and TGA audited contract research facilities undertaking finished product manufacture and early phase clinical trials for local and international pharmaceutical companies. This included roles in Regulatory Affairs at GlaxoSmithKline, Pharmacia, Faulding, Amrad Corporation and Acrux; Scientific Affairs at IDT Australia Ltd; and General Manager at both CMAX Clinical Research and Nucleus Network Phase I clinical units. In 2008, Craig established PPP based on his gap analysis of the services available in the local market to support clinical trial manufacturing and logistics. Craig has overseen the planning and implementation of the fit-out and qualification of all PPP facilities and has been institutional in growing all aspects of the business. Craig is responsible for managing all licences, including the GMP licence from the Therapeutic Goods Administration (TGA).
Telephone: +61 3 9673 1003
Bev has 18 years of pharmaceutical industry experience, including responsibilities across operations, business development and general management. Prior to joining PPP Bev was CEO at Nucleus Network, leading the organisation through a successful period of significant growth. During this time at Nucleus Network, the facility capacity was increased from 24 to 55 beds, with a doubling in facility footprint. Prior to her roles at Nucleus, Bev was Investment Manager at Brandon Capital Partners, who provide seed and venture capital investment to support the development and international growth of Australian and New Zealand life science companies. Bev has extensive experience in performing business case analyses for both operational and technology-based opportunities. Bev was also historically responsible for the establishment and ongoing management of internal analytical capabilities at Acrux.
Divyang has over 20 years of experience in the pharmaceutical industry, including roles as Logistics and Manufacturing Manager at IDT, VP of CMC and Bioanalytical at Phosphagenics and most recently as Project Director at PPP. In these roles, Divyang has gained significant experience in establishing and managing analytical laboratories, leading operational aspects of manufacturing departments in compliance with international regulatory agencies, such as TGA and FDA. He has also been involved in implementing facility fit-out modifications and introduction of new equipment and technology.
Manager Murray has eleven years of experience in the pharmaceutical industry including previous positions with Progen Industries and more recently CSL Ltd. He has spent the past 5 years in R&D Quality Management at CSL where he was directly involved developing and managing the quality aspects of an upgrade to CSL’s clinical formulation, filling and lyophilisation facility. This focus on manufacturing of aseptic products followed a six-year period working in R&D at CSL in aseptic formulation, fill and finish of sterile liquid and freeze dried investigational medicinal products to supply clinical studies and in the development and scale up of stable formulations. In this role, he was also involved in analytical assay support and method development for in-process and release testing for these products.
Brenda is a registered pharmacist who has 7 years’ experience in logistics management for investigational medicinal products (IMP). Brenda previously worked for 6 years with World Courier as the Depot Pharmacist gaining expertise in warehousing, labelling and distribution of IMP. Since joining PPP in 2016, Brenda has been employed as Clinical Trials Logistics Manager with PPP and oversees warehousing, storage and distribution of clinical trial medication.
Kamal has 12 years’ experience in accounts and finance. He has worked with PPP for 3 year managing the financial function. Prior to joining PPP, he worked with various businesses including real state, financial consultancies and accounting firms in Australia and India. Kamal has a Masters Degree in Professional Accounting from the University of Ballarat and holds a Masters Degree in Commerce and is pursuing CPA.
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.