PS 9000 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal product and now orally inhaled medicine, with reference to Good Manufacturing Practice (GMP).
Its 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.
The standard is aligned to ISO 15378 (Primary packaging materials for medicinal products) and based on these principles as well as ISO 9001. Fully recognised and supported by the MHRA, it incorporates many quality management principles in line with GMP and regulatory requirements.
The 2011 revision has added focus on electronic origination and controls and the interface with production throughout all process steps, as well as ensuring the importance of controls in terms of traceability and verification of materials throughout the process chain.
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 9000:2011. Call 0800 783 2179 or email enquiries for more information.