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.
How can PS 9000 benefit my organisation?
PS 9000 is a standard relevant to all parts of the pharmaceutical industry supply chain, allowing shared knowledge, practices and implementation to manage risks and safeguard the well being of people and business.
Whether a contractual need or simply looking to reduce overall risk to your organisation and products, there are a number of key benefits to implementing a certificated PS 9000 system.
- Quality Controls - Clear implementation of practices across production process including electronic interfaces to assure quality products, fit for purpose and minimising counterfeit medicines
- Personnel/Communication - More clearly understand roles and responsibilities in terms of producing quality products
- GMP - Incorporation of specific Good Manufacturing Practice requirements which assure material are appropriate quality and correct procedures are followed in terms of checking, traceability, contamination and hygiene controls
- Risks - Structured approach to risk management and key focus on risk areas associated with packaging operations, with effective controls and activities detailed, which ultimately helps to reduce potential product and business issues
- Compliance - Used in support of regulatory compliance and identification of appropriate legislation
- Harmonisation - Helps integration of Regulatory, Quality and GMP requirements
- Commitment - Organisations need to show their compliance with all relevant statutory and regulatory pharmaceutical packaging safety and GMP requirements in addition to their own policies.
Need to know more?
We provide gap analysis and certification to PS 9000:2016. Call 0800 783 2179 or complete our enquiry form for more information