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.

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