GMP Consultants, Qualification & Validation, Engineers & Architects
PharmOut is a rapidly growing international consultancy offering GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.
We aim to give you a competitive advantage by helping you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by regulatory agencies such as the US FDA, MHRA, CFDA and PIC/S member agencies such as the Australian TGA, New Zealand MedSafe, Singaporean HSA to list a few of the nearly 50 PIC/S member agencies.
As one of the regions leading pharmaceutical consulting companies, our expert GMP consultants, GMP trainers, pharmaceutical engineers and architects provide practical, cost effective GMP compliant design solutions, which have a focus on improving your bottom line across the entire life cycle of your products.
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What PharmOut offers:
QA and GMP consulting
Pharmaceuticals – Our GMP consultants can offer practical knowledge and experience on implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10 / ISO 9001:2015 for Pharmaceuticals. PharmOut will work from a series of templates and experiences based on many successful past projects and quickly install policies, procedures, work instructions and records. More >
GMP audits – We help with GLP, GMP gap audits / assessments and remediation plans to help you prepare for successful GMP audits and inspections from agencies such as the TGA/MHRA/US FDA. More >
Medical devices / IVDs – We understand, and have implemented a number of ISO 13485:2016 (old ISO 13485:2003) Quality Management Systems for medical device manufacturers as well as implementation to meet US FDA 21 CFR Part 820 requirements in the past few years. More >
Blood and tissue – Our GMP consultants can advise on blood and tissue GMPs, including the country-specific GMPs like those issued by the TGA or Annex 2 from the EU and PIC/S codes of GMP. More >
Pesticide and veterinary drug – We can assist with GMP compliance to the US FDA, EU and the APVMA GMP codes. More >
Qualification and Validation of facilities, utilities, systems, equipment and computerised systems
- Pharmaceutical and Medical Device process validation to PIC/S, EU EMA and US 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 US FDA 21 CFR Part 11 and TGA, EU and PIC/S PE 009 Annex 11 regulations.
- Temperature mapping of warehouses, cold rooms and other temperature controlled spaces.
Architectural and engineering consulting services
- We can design world class health science facilities such as hospitals, aged care units, GMP-regulated manufacturing sites and scientific laboratories.
- Our 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.
- Our facility design review services will ensure regulatory compliance and efficient workflows within a facility.
GMP training, On-site and Public training for the pharmaceutical, biotech, medical device & veterinary industries
- We offer a wide range of on line GMP training courses, these can we done as individual courses, our bundled courses focused by industry, or region, regulatory agency, i.e. TGA, MedSafe, PIC/S, US FDA or EU.
- We regularly offer a wide range of public GMP training courses in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney, current our most popular course is the Sydney GMP Training Course.
- Lastly, we frequently fly to any location in the world and deliver GMP training on-site.
Regulatory affairs – medical device / drug registration
- Provide advice and answer your questions on the Australian TGA’s medical device and drug registration process.
- Prepare dossiers to support drug or device registration with the TGA.
- Conduct mock ISO 13485 audits.
Continuous improvement – lean manufacturing, Six Sigma
PharmOut’s pharmaceutical engineers have years of manufacturing and regulatory compliance experience. They are experts in managing continuous improvement projects, which are often 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?
If you need human resources for a project, we have:
- Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice at competitive rates.
- Registered Building Practitioners and Architects and Engineers to design and build your plant, pharmacy or provide other general engineering services.
Pharmaceutical consulting company
PharmOut operates internationally with local offices around Australia (Adelaide, Melbourne, Sydney and Brisbane), Hong Kong, UK and New Zealand.
PharmOut’s Pharmaceutical Engineers, Architects and Consultants each have many years of experience in the pharmaceutical, biotech, pharmacy, veterinary and 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 help you 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?