Did you know ?
OPM are now fully certified to PS9000:2011
This means we have successfully completed the formal four day audit process set out by the Pharmaceutical Quality Group.
This accredited certificate confirms that OPM are audited by the Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA), so that OPM clients have a guarantee that OPM products are manufactured to the required standard of GMP within the pharmaceutical packaging supply industry.
PS 9000 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal products 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 labels and flexible packaging 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 global regulatory requirements.
How does PS 9000 benefit OPM Customers, Suppliers and end users?
To implement a certificated PS 9000 system OPM ensures that we work to the guidelines below giving our clients and their customers confidence in OPM’s products and services.
GMP – The OPM Team follow Good Manufacturing Practice requirements to ensure all product materials are of appropriate quality and correct procedures are followed in terms of traceability, checking, hygiene controls and contamination
Positive Communication & Training – OPM ensure every member of the team clearly understand roles and responsibilities in terms of producing quality products within the pharmaceutical packaging supply industry. This is done through a continuous training program and communicated by all levels within the organisation.
Teamwork – Helps integration of Quality, Regulatory and GMP requirements
Quality Control – OPM implements controlled practices critical for traceability and verification of materials across administration, repro and print production processes. This includes electronic automation direct with our MIS system and 100% inspection software to assure manufacture of quality fit for purpose label and flexible packaging products, minimising the risk of counterfeit medicines.
Risk Management – OPM has a structured approach to risk management and is focussed on key risk areas associated with packaging operations, with effective controls and monitored activities detailed & recorded
Commitment to Compliance – OPM manufactures in compliance with regulatory, relevant statutory pharmaceutical packaging safety and GMP requirements in addition to their own policies.