PharmOut is an Australian-headquartered consultancy with offices in most cities in Australia and around the world, as TGA consultants, we specialize the design and operation of pharmaceutical, veterinary, device and cosmetic manufacturing facilities.
Our complete, turn key architectural, engineering, compliance and validation services can assist your next facility design, you can be confident that you will get a optimal design that ensures, consideration of value engineering, “lean” manufacturing and finally TGA approval.
With offices across Asia Pacific, headquartered in Melbourne, we frequently travel within the Asia Pacific region delivering compliance to PIC/S and TGA GMPs.
TGA GMP Compliance
Our GMP consultants can ensure your Quality System meets the requirements of PIC/S and TGA and of ICH Q10 / ISO 9001 for pharmaceutical manufacture. We have a wealth of QMS templates and documents that we can use to quickly create policies, procedures, work instructions and forms. More >
If you are about to be audited by the Australian TGA or have already been, we can help with GMP GAP audits / assessments and GMP remediation plans.
Medical devices / IVDs
We can help you with an ISO 13485 Quality Management System or support you through meeting US FDA CFR820 requirements. More >
Architectural and engineering consulting services
We design manufacturing facilities, clean rooms from the optimising the process and work flows first, then wrap the clean room or building around the process, we specialise in GMP-regulated manufacturing sites, but have a proven record in the delivery of laboratories, pharmacies, food and cosmetic plants.
GMP Engineering consulting
If you are planning to build a GMP facility, our engineering consulting services will ensure regulatory compliance and efficient workflows within the facility.
Our GMP consultants and pharmaceutical engineers are experts in GMP facility and clean room design and classification. You can avoid costly mistakes by making sure the design of your new clean room or GMP facility adheres to the correct standards.
We can design a validation protocol or supply validation engineers to ensure compliance with Australian TGA or FDA pharmaceutical or medical device process validation regulations.
Our validation engineers can perform pharmaceutical equipment validation to international regulatory standards and in accordance with current GMPs.
If you need cleaning validation for pharmaceutical and medical device manufacturing facilities, our validation engineers can perform a range of tasks, ranging from preparing the high level validation plan through to actually doing the cleaning validation.
Computer Systems validation
Computer systems validation to FDA Part 11 and PIC/S Annex 11 regulations is another common request from our customers. We apply the ISPE’s GAMP approach to our computer systems validation.
PharmOut has the specialized equipment and expertise to undertake temperature mapping of warehouses, refrigerators and cold rooms. This is to ensure compliance with good warehousing practices for time and temperature sensitive pharmaceuticals and other products subject to cold chain management.
Training for the pharmaceutical, medical device & veterinary industries
We offer class room training or on line GMP training around the world.
Manufacturing continuous improvement
Lean Manufacturing, Six Sigma
If you are trying to reduce costs and waste and streamline your manufacturing processes, all while maintaining regulatory compliance then we can help. Our GMP consultants are experts in managing Continuous Improvement projects, which are often difficult to do in a regulated GMP environment.
GMP project resources
If you have a project that needs experienced GMP professionals or several contractors, PharmOut can supply: