> Quality and certification
The MEG team assures the quality of its products and services at every stage of the supply chain. MEG monitors the quality of its processes, products and suppliers. We take our customers’ concerns about the quality of their human products completely out of their hands, and this makes all the difference.
Medical Export Group ensures that distributed products and services comply with international standards at every stage of the supply chain. National regulatory requirements and specific client requirements are also satisfied.
This policy is met through:
- Quality and personal commitment at all levels and in all processes
- Integrated understanding of systems, risk management and processes
- Constant focus on system improvements, both internal and external
QUALITY MANAGEMENT SYSTEM
Medical Export Group is compliant with EU guidelines regarding Good Distribution Practice (GDP) for the distribution of pharmaceutical products and is inspected and duly licensed by the Dutch Pharmaceutical Inspectorate.
Medical Export Group (MEG) maintains a high level of service and ensures the supply of high quality products by following the principles of the Model Quality Assurance System, in line with WHO guidelines. MEG also holds a NEN-EN-ISO 9001:2015 certificate from Lloyds and is an Authorised Economic Operator (AEO). Furthermore, MEG’s Quality Assurance (QA) and Quality Control (QC) systems and processes have been assessed and approved by several clients including USAID, UNFPA and WHO.
QUALITY ASSURANCE (QA)
In broad terms, the Quality Assurance (QA) system is designed to ensure and to document:
- The knowledge and motivation of employees through consultation, education and training
- Consistent updating and application of procedures in line with GDP (Good Distribution Practice) principles
- Supplier screening and use of approved manufacturers and products
- Supply of safe and quality products
- Relevant quality documents directly linked to our ERP system
- System for handling corrective and preventive actions (CAPA’s)
- System for handling complaints and deviations
- Correct handling of products during storage and distribution
- Full batch and kit/batch traceability from manufacturer to customer
- Performance of self-inspection of all areas including QA/QC and warehouses
- Specific KPIs (Key Performance Indicators) to monitor critical processes
Medical Export Group runs its own comprehensive supplier and product qualification system which enables us to respond to the global demand for product diversity.
The scope of MEG’s qualification system covers both pharmaceutical products and medical and laboratory supplies. MEG’s sourcing of medicines focuses on SRA/WHO approved sites. In cases where this is not feasible, MEG’s qualification system verifies and ensures that the products are manufactured according to the GMP standards (pharmaceutical products) or ISO/EU standards (non-pharmaceutical health products) and that the quality of the products meets the policies and standards MEG has defined and where applicable, the National Drug Regulatory Authority (NDRA) requirements in the recipient country.
PRE-QUALIFICATION OF MANUFACTURERS AND PRODUCTS
Our pre-qualification system is an ongoing combination of document assessment and review, using the International Pharmaceutical Product Questionnaire (WHO standard) and where applicable, on-site GMP Audits.
Quality Control (QC)
All pharmaceutical products and medical devices provided by MEG are subject to review and release by the MEG Quality Control System.
QC TESTING by MEG
To verify whether the quality of a product conforms to the standards, Medical Export Group has pre-defined a risk-based Quality Control Analysis/ testing programme.
In the case of a recall, our ERP system ensures the fast and easy tracking of all batches distributed. All recipients will be notified immediately about the reason for the recall with details of the product, batch number and the exact quantity involved.
Complaints are handled by the QA department according to defined internal SOPs and in accordance with GMP/GDP requirements. Apart from dealing with complaints from customers, attention is also paid to investigating and resolving any internal irregularities found. Our multidisciplinary quality team performs root cause analysis, draws up a CAPA and shares the observations and lessons learned with all relevant departments.
Good Distribution Practice (GDP, Directive 92/25/EEC)
Authorised Economic Operator (AEO)