GMP Consultants, GLP Consultants & Validation Engineers

PharmOut is an Australian-based GMP consultancy, design and engineering company with offices across the Asia Pacific region.

We offer services in:

QA/GLP/GMP compliance

Pharmaceuticals

Our GMP consultants can ensure your Quality System meets the requirements of the 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 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 >

Blood and tissue banks

Our GMP consultants can help you determine which GMP codes you need to comply with, including: PIC/S, the EMA, the US FDA and the Australian TGA.  All have regulations for human blood and tissue banks. More >

Pesticides and veterinary drugs

If your product must comply with the  APVMA GMP code for pesticides or veterinary drugs then we can help you work through what you need to do to comply. More >

Architectural and engineering consulting services

Architectural design

We can design health facilities such as hospitals and aged care homes as well as GMP-regulated manufacturing sites and health science laboratories.

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 GMP 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.

Validation

Process validation

We can design a validation protocol or supply validation engineers to ensure compliance with TGA or FDA pharmaceutical or medical device process validation regulations.

Equipment validation

Our validation engineers can perform pharmaceutical equipment validation to international regulatory standards and in accordance with current GMPs.

Cleaning validation

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 TGA Annex 11 regulations is another common request from our customers. We apply the ISPE’s GAMP approach to computer systems validation.

Temperature mapping

PharmOut has the 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

You can choose to individually attend a scheduled GMP training session or have group training at your site. Our training courses include:

Regulatory affairs

Medical device  or drug registration

If you have a medical device or a pharmaceutical product that you want to sell in Australia, we can provide advice on the TGA’s medical device and drug registration process. This includes preparing dossiers to support the TGA drug or device registration process.

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: