The Company’s policy of gaining a full understanding of the local laws and regulations of each of the countries within which it operates offers the total assurance of dealing with an organisation that conforms to the highest quality standards.
Taking pride in our service, our quality and our conduct, we have a Quality & Regulatory team in place offering assurance and compliance across the Masters group that is closely monitored and managed by our Director of Quality Assurance and Regulatory. Furthermore, Masters also offers a wealth of experience in regulatory affairs and compliance in its operating markets, having essential regulatory knowledge situated at a local level.
We have in place:
- Standard Operating Procedures (SOPs) to describe all operational and quality related aspects of the business.
- Established Continuous Improvement (CI) models to drive business and process development.
- SAP implemented across all our business functions allowing full batch traceability.
- Ongoing temperature mapping and calibration schedules to ensure the validity of temperature controlled storage and distribution equipment and facilities.
- Effective systems for the ongoing review and approval of all vendors that assures appropriate licensing and therefore the maintenance of a legitimate supply chain.
- A staff training program that ensures all staff are competent in the appropriate methods of handling, storing and logistics of pharmaceutical products
All Masters sites are licensed and inspected by the competent authorities in the territories of operation; in the UK by the Medicines and Healthcare Regulatory Agency (MHRA); in the USA by the State of Florida Department of Business and Regulations; in Brazil by Anvisa; and in El-Salvador by the DNM National Directorate of Medicines.
Our Quality agenda is simple; ensure quality and patient safety at all times. To help Masters to achieve this we have recruited key staff in our Quality and Regulatory department to build robust systems which will support both the business and Customers alike, whilst ensuring continuous improvements in Masters commercial activities. We have fully revised our Quality Management System (QMS) introducing both new and revised processes. In our warehouse ambient Products are now stored under “controlled ambient” conditions, 15oC to 25oC. We have also installed and validated a new wireless temperature monitoring system which maintains a continuous record of the temperature in all areas of the warehouse, including the cold store, providing 24 hour, 365 days a year, real time data monitoring and alerts.