PharmOut is a multi-disciplinary team of expert pharmaceutical architects and engineers, we are Australia’s leading pharmaceutical clean room designers, working for cosmetics manufacturers, non sterile and sterile pharmaceutical manufacturers around the world to provide Architecture and Engineering services. Manufacturers, often set a challenge for PharmOut’s process engineers to scale up or replicate processes. PharmOuts standard…
Old news I know, and you probably always have done it this way, but did you know with the January 2018 adoption of PIC/S PE009-13 by the TGA, a User Requirement Specification (URS) is now mandatory? Annex 15, §3.1 and 3.2 state that a User Requirement Specification should be a point of reference in the…
Saying yes to a client on the job is always the right response. Isn’t it? An ever present necessity in the workplace and life in general is working well with others. It is one of the main factors of how our species came to dominate the planet. But what does that really mean? Does it…
New PIC/S GMP version 13 The TGA finally formally announced adoption of the new PIC/S GMP version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017! In this public statement the TGA announced: from 1st January 2018, the TGA GMP inspectors will use the new GMP Guide during inspections. Compliance with the…
In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two new clauses §1.5 and §1.6 (Part 1 of the PIC/S GMP) had on the Australian industry, as we followed the USFDA…
Biodecon Solutions Biodecon Solutions was established to provide unique, safe and proven biological decontamination and containment solutions for Australia and New Zealand. Operating in the Pharmaceutical, Bio-Medical, Healthcare, Bio-Technology, Life Science and Food Preparation industries, we provide automated products and services that validate and guarantee 6-log sporicidal reduction of surface contamination as well as specialist…
The focus on innovation continued into the 2017 pharmaceutical conference as we shared ideas and experiences around industry hot topics and some new concepts like Industry 4.0. Included topics in 2017 were Data Integrity, Quality Metrics, PIC/S Version 13 – Part 1, Annex 11 and Annex 15 and the massive changes for industry. Thank you…
Komipharm Australia Selects PharmOut as Architectural and Engineering Consultants Komipharm Australia is part of a leading Korean producer of drugs for human and veterinary use, Komipharm International Australia Pty Ltd plans to design and build one of the largest pharmaceutical (high – potency) tablet manufacturing facilities in the world in Dandenong South, estimated investment is…
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Phone: +61 3 9887 6412
Email: info@pharmout.net
