Case studies

Here are some examples of PharmOut’s work and the outcomes we’ve delivered for our clients:

Medicinal Cannabis Facility and GMP Engineering

Case study about a global corporation seeking medicinal cannabis facility design and engineering consultancy for GMP and EU GMP compliance to meet the medicinal cannabis export market as well as the Austalian market.  The project involved two facility designs including licence applications and architecture, engineering and documentation to meet TGA PIC/S and EU GMP compliance requirements.  Read more…

PIC/S GMP Training

Based on our experience, if a regulatory agency wishes to join PIC/S, it’s essential that the inspectorate and industry embark on a “joint journey” for the national good.

Combining Lean Manufacturing with GMP

GMP Compliance Remediation Project

A large multi-national medical device company asked PharmOut to help respond to the notices of deficiencies from a TGA audit in order to achieve sustainable compliance.

Recruitment for the Pharmaceutical Industry

PharmOut was approached by a small pharmaceutical company to fill a Quality Assurance Manager role.

ISO 9001 + ISO 13485 = Profit

North American companies in the late 1980’s and early 1990’s got the marketing equivalent of a kick in the face from Japanese companies bringing in consumer products that were both low priced AND high quality.

Recovering from Vendor Assurance Problems

An Australian company acting as the Australian sponsor for a range of imported sterile medical devices contacted PharmOut after they were hit with a notice from the TGA that their imported products had been tested and were found to be non-sterile.