News
August 5th, 2010 - Book now for the 'How to achieve environmentally sustainable GMP facilities" seminar and workshop with international expert Gordon Farquharson. More >
July 2nd, 2010 - Preparing for GMP Audits whitepaper updated to include insider tips on auditor expectations and TGA processes. Download >
June 1st, 2010 - White paper released: How to Implement a Quality Management System. Download >
TGA GMP Compliance, Regulatory Affairs & Validation Consultants
PharmOut offers practical, simple GMP, Validation and Regulatory solutions for companies seeking to obtain a competitive advantage and compliance to TGA PIC/S GMP. Who better to help, than ex TGA auditors and/or one of our well trained and experienced consultants, the training and development of our staff is greatly appreciated.
Our philosophy is simple - write concise quality systems or validation protocols that tell your team what to do and then make sure you or your team do what has been written.
If you are looking for TAG GMP Consultants or Validation Consultants that will build a quality systems or validation protocols that are a monument to "our technical brilliance" then PharmOut is not for you.
If you are interested, please read more about our range of services below. We offer GMP regulatory advice, practically applied.
What we offer:
Training to the Pharmaceutical, Medical Device & Veterinary industries
- We offer a wide range of Validation, GLP training and GMP training courses.
- 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.
GLP/GMP Compliance
- GLP/GMP Quality Management Systems, GAP audits and assessments
- Practical recommendations and advice on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOPs and Forms.
- Pharmaceutical Maintenance - we can audit your engineering department for compliance to TGA, FDA and ISPE baseline recommendations.
- We can assist with Veterinary Drug GMP compliance to the APVMA GMP code.
Validation - Process, Equipment, Cleaning & Computer
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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
Regulatory Affairs - Medical Device / Drug registration
- Providing advice and answering your questions on the Australian TGA's medical device / 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:
Headquartered in Melbourne, Australia we operate throughout the Asia Pacific region. PharmOut 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, let alone ensure that you comply?
Who will benefit from our services?
Business results focussed Quality Assurance, Manufacturing and Engineering Professionals in pharmaceutical, veterinary or medical device companies looking to improve your GMP compliance.
Australia | China | New Zealand | Singapore | South Africa
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NEW RECOMMENDATION - GMP Annex 1 Interpretation of the most important changes for the manufacture or of sterile products. PIC/S issues Annex 1 recommendations for sterile manufacture - 1 December 2009.