TGA Consultants for GMP, Validation, Regulatory & Engineering

A consultancy offering GLP, GMP, validation, regulatory and engineering services, to benefit companies seeking to build, operate and obtain a competitive advantage and compliance to the TGA GMP regulations. Our GMP consultants, some ex TGA auditors and practical hands on operations and QA staff can ensure business and TGA compliance success.

What we offer:

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 managements systems.
• Pharmaceuticals - GLP, GMP GAP audits / assessments and remediation plans, in 2011 we assisted over 15 companies with TGA/FDA audit "enhancements".
• Medical Devices / IVD's - Practical knowledge and a proven track record with experience on how to implement or enhance ISO 13485 for Medical Device Quality Management Systems.
• Blood and Tissue - Our GMP consultants can advise on blood and tissue GMPs.
• We can assist with Pesticide and Veterinary Drug GMP compliance to the APVMA GMP code. 

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 Company

• 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, 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.

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.

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?

Who we are:

With headquarters in Australia, Pharmout operates internationally with offices in 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? 

Who will benefit from our services?

Quality Assurance, Manufacturing and Engineering Professionals in pharmaceutical, veterinary or medical device companies looking to improve not only their GMP compliance but also the bottom line across the entire life cycle of their projects.