CFDA and PIC/S GMP Consultants, Validation and GMP services
PharmOut is a Hong Kong based consultancy, specialising in PIC/S GMP compliance and validation with offices across Asia Pacific, headquartered in Melbourne, we frequently travel within the Asia Pacific region delivering compliance to PIC/S and CFDA GMPs and into China.
We offer services in:
Our GMP consultants can ensure your Quality System meets the requirements of PIC/S and CFDA 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 CFDA 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 >
We can design a validation protocol or supply validation engineers to ensure compliance with CFDA 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: