PS 9000 is developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal product including orally inhaled medicine, and it defines specific requirements and guidance for Good Manufacturing Practice (GMP).
The updated version of the standard was revised in July 2016. PS 9000:2016 is aligned to ISO 15378 (Primary packaging materials for medicinal products) and the new ISO 9000:2015 Quality Management Standard. It is also fully recognised and supported by the MHRA, and it incorporates many quality management principles in line with GMP and regulatory requirements.
PS 9000 standard’s primary objective is to facilitate risk management and implementation of a controlled system to eliminate these risks to ensure production of safe products to correct requirements.
It is an interactive standard that can be applied to Global, Primary, Secondary and Complex manufacturers, each with specific requirements.