Blog post - How to get QA buy-in to Cleanroom turndown
New White Paper - Code of GMP Chapter 4. Documentation - PIC/S versus EU download.
TGA presentations at the National Validation Forum II are now available on the TGA website.
We are pleased to announce that Shelley Tang joined PharmOut to enhance our device registration service.
Download our new White PaperEMA Draft Guidance: Process Validation for a summary of proposed PV changes.
Ex Head of TGA GMP section, Tony Gould, joins PharmOut.
PharmOut is an Australian based international "GMP consultancy" that offers QA, GLP, GMP, validation, regulatory and engineering consulting services to Quality Assurance, Manufacturing and Engineering Professionals in pharmaceutical, veterinary or medical device companies. We give you a competitive advantage by helping you build and operate manufacturing facilities that comply with TGA and international GMP regulations.
Our GMP consultants provide practical, hands-on operations and QA staff can ensure TGA-audit success, and an improved bottom line across the entire life cycle of your products.
What PharmOut can offer you:
Pharmaceuticals - Our GMP consultants can offer practical knowledge, based on a proven track record and experience on how to implement or enhance Quality Systems aligned with the TGA GMP requirements and ICH Q10 / ISO 9001 for Pharmaceuticals. PharmOut will work from a series of templates and past projects and quickly install Policies, Procedures, Work Instructions and Forms. In 2011, we assisted over 20 companies with implementing Quality Management Systems.More
Pharmaceuticals - GLP, GMP GAP audits / assessments and remediation plans. In 2011, we helped over 15 companies prepare for successful TGA/FDA audits..More
Medical Devices / IVDs - Practical knowledge and a proven track record with experience on how to implement or enhance ISO 13485 for Medical Device Quality Management Systems as well as the US FDA CFR820 requirements. More
Blood and Tissue - Our GMP consultants can advise on blood and tissue GMPs. More
Pesticide and Veterinary Drug - We can assist with GMP compliance to the APVMA GMP code. More
Who we are:
PharmOut operates internationally with offices in Australia (Melbourne, Sydney and Brisbane), China, Hong Kong, UK, France, New Zealand, Singapore and South Africa. PharmOut's Engineers and consultants each have many years of experience in the pharmaceutical, veterinary or medical device industries. Experience that has seen most of the problems that can occur in facility design, scale up development and manufacturing. Experience that can prevent you making mistakes, or solve them if it is too late.
As consulting professionals it is our job to stay up to date with current regulations so that we can be sure our customers comply. Have you got time to read them all, are you sure you are compliant?
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