MedSafe GMP Consultants and Engineers
PharmOut is an Auckland based pharmaceutical consultancy, specialising in the GMP design, architecture, engineering and validation with offices across Asia Pacific, headquartered in Melbourne, we frequently travel within the Asia Pacific region delivering compliance to PIC/S and Medsafe GMPs.
We offer services in:
Our GMP consultants can ensure your Quality System meets the requirements of PIC/S and Medsafe 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 >
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 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 New Zealand Medsafe 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
MedSafe GMP project resources
If you have a project that needs experienced GMP professionals or several contractors, PharmOut can supply: