TGA Consultants, Validation, Engineering & Architecture and GMP services
PharmOut is an Australian-based consultancy, specialising in GMP design, architecture, engineering and validation with offices across Australia, headquartered in Melbourne, we also have office in Adelaide, Brisbane, Perth and Sydney with a number of expert FDA, EU and TGA consultants / engineers.
We offer services in:
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 >
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
We design manufacturing facilities, clean rooms from the optimising the process and work flows first, then wrapping the clean room or building around the process, we specialise in GMP-regulated manufacturing sites, but have an extensive record in 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 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.
We can design a validation protocol or supply validation engineers to ensure compliance with 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 TGA 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 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:
- Good Manufacturing Practice (GMP)
- Good Documentation Practice (GDP)
- Good Laboratory Practice (GLP)
- Computer System Validation
- Process Validation
- GAMP5 and computerised systems compliance
- Pharmaceutical Quality Risk Management
- Medical Device Quality Risk Management – ISO 14971
- Quality Management Systems – ISO 13485:2016
- Achieving a successful GMP audit
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.
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:
- Pharmaceutical Engineers,
- GMP Consultants,
- Validation Consultants,
- Regulatory Affairs Consultants
- Technical Document Writers
- GMP Engineers