PS 9000 is based on the ISO 9001 quality management standard. PS 9000 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicines and it defines specific requirements and guidance for Good Manufacturing Practice (GMP).
PS 9000’s primary objective is to facilitate risk management and implementation of a controlled system to eliminate risks to ensure production of safe products to correct requirements. Whether you have a contractual need or are 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.
i2ISO can help you develop and implement your PS 9000 quality management system. We are specially qualified having recently completed the course and passed the exam on Quality Management Systems Lead Auditor Training Course Based on EU GMP for the Pharmaceutical Industry and its Suppliers. The training course is approved by the Chartered Quality Institute (CQI) and the International Register of Certified Auditors (IRCA).