Quality / GMP
R2 Pharma Solutions is primarily a GMP consultancy and have the expertise to develop and implement a complete Pharmaceutical Quality System (PQS) or Quality Management System (QMS) for a manufacturing facility.
Good Manufacturing Practice (GMP) that includes principles of Quality Management System can be implemented for any type of product using a number of different standards.
R2 Pharma Solutions can assist with the complete implementation of the following Quality Management Systems.
- TGA Manufacturing license (PIC/S)
- ISO 9001 Quality Management System
- ISO 13485 Quality Management System for Medical Devices
- Australian Pesticide and Veterinary Medicine Authority (APVMA) GMP Code
We can also perform a Gap Analysis of your current GMP system vs QMS pertaining to ISO standards, TGA PIC/S or APVMA GMP. This will provide a better understanding of the scope of the project and the depth of work needed to reach the goals.
Contact us for a non-binding quotation to assist you with obtaining a GMP certificate.