PharmOut was established in Melbourne, Australia in 2006. We now have offices across the Asia Pacific region, including Durban, South Africa.
We have over 40 consultants with expertise in PIC/S, FDA and TGA GMP compliance, validation and continuous improvement and regulatory services.
Our key offering is practical, pragmatic, GMP compliance. No mountains of paper. No complicated processes. No tears.
To give you some idea of the depth of our experience, meet our executive consultants and directors:
PharmOut's Managing Director, Trevor Schoerie has 21 years of manufacturing and 8 years of consulting experience in the chemical, pharmaceutical, pesticides & veterinary drugs industries.
Trevor believes strongly in sensible, practical compliance that delivers business results, not just audit success.
His area of expertise is in combining Good Manufacturing Practice (GMP) compliance with continuous improvement methods such as Lean Manufacturing.
Dr. Andrzej Wozniak was previously the Manager of the Medicines Audit Team with the Australian Therapeutic Goods Administration (TGA).
He has extensive experience in biologics, dossier review, product testing and auditing of all types of pharmaceutical manufacturers.
Andrzej also spent three years as chairperson of the TGA's Technical Working Group for Sterile Medicines and was a member of the PIC/S Expert Circle for Active Pharmaceutical Ingredients (APIs) and a committee member during the period 2004-2010.
Andrzej is an Executive Consultant with PharmOut.
Bob Tribe is an experienced and approachable industry veteran who has been a key player in the development of the GMP standards and their application within Australia and internationally.
Bob was previously the Chief GMP Auditor for the Therapeutic Goods Administration (TGA), Australia (1980 – 2003) and Chairman of the Pharmaceutical Inspection Cooperation Scheme [PIC/S] (2000 – 2001).
He is a current regulatory advisor to the International Society of Pharmaceutical Engineers (ISPE) and a special advisor to a number of regulatory authorities seeking PIC/S accreditation.
Bob is an Executive Consultant with PharmOut.
Gordon Farquharson is widely recognised as a world leader and expert in sterile products manufacture, clean room design and maintenance and utilities for the same.
Gordon is the Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards.
He is also an advisor to the European Medicines Agency (EMA) concerning the revision to Annex 1 of the European Union's GMP in February 2008 and a member of the World Health Organisation (WHO) expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).
Gordon is an Executive Consultant with PharmOut.