GMP Consultants, GLP Consultants & Validation Engineers / Consulting Engineers

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:

QA/GLP/GMP Compliance

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

Validation - Process, Equipment, Cleaning & Computer

• Pharmaceutical and Medical Device Process Validation to TGA and FDA regulations.
• Pharmaceutical Equipment Validation to international regulatory standards and in accordance with current Good Manufacturing Practice.
• Cleaning Validation for pharmaceutical and medical device manufacturing facilities.
• Computer Systems Validation to FDA Part 11 and TGA Annex 11 regulations.
• Temperature Mapping of warehouses and cold rooms.

Engineering Consulting Services

• We offer a wide range of engineering consulting services across the six stages of engineering projects.
• Our GMP and Engineering staff are experts in facility and clean room design and classification. They will ensure that work done on clean rooms adheres to the correct standards helping to avoid costly mistakes.

Training to the Pharmaceutical, Medical Device & Veterinary industries

• We offer a wide range of Validation, GLP training and GMP training.
• Our extensive range of training courses include GAMP 5 training, ISO 13485 training and Q9 / ISO 14971 quality risk management training courses.

Regulatory Affairs - Medical Device / Drug registration

• Providing advice and answering your questions on the Australian TGA's medical device and drug registration process.
• Preparing dossiers to support drug registration with the TGA.

Continuous Improvement - Lean Manufacturing, Six Sigma

• Continuous Improvement projects are difficult to initiate and implement in the highly regulated pharmaceutical environment. Why not talk to PharmOut experts, knowledgeable in both Continuous Improvement and GMP requirements?

Our People

• Outsourced consultants to work on your site under your direction at short notice for short or long duration projects.
• We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice at competitive rates.
• We supply Engineers to review your plant design or provide other general engineering services.

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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