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Quality requirements
The laboratory technician checks the laboratory equipment. © action medeor/B. Betzelt
Each manufacturer and supplier has to pass our pre-qualification process before being considered as a supplier for action medeor.
Supplier Qualification
Based on our prequalifying questionnaire we request key data and critical documents from every company such as valid GMP and GDP certificates. Our internal pharmacy department checks all submitted documents before releasing a supplier.
Suppliers / manufacturers who have previously been inspected by an European, a SRA authority or the WHO may provide the first delivery without being audited by action medeor beforehand. However, during our annual supplier evaluation we can schedule audits at any time.
When manufacturers are located outside the EU and are neither prequalified nor have been inspected by either the WHO or by another stringent authority, action medeor always conducts an audit first. Audits are carried out by a pharmacist from action medeor together with an international auditor. We would like to point out that action medeor does not accept third-party audits, for example by wholesalers.
Product Qualification
All of our prequalified suppliers / manufacturers can participate in our calls for tender. For this purpose, suppliers / manufacturers need to hand in a completed product questionnaire along with all the necessary documents for verification. The tender will be awarded according to an established procedure. Core criteria for evaluation are the following:
- Manufacturer specification meets action medeor’s requirements
- The product is authorised (in the country of manufacture, SRA country or another country)
- ICH stability data exists
- The API manufacturer is GMP compliant
Additional important evaluation criteria are: labelling, package insert, shelf life, storage conditions and documentation confirming drug quality (CEP or DMF).
Quality control
All medicinal products are subject to incoming goods inspection by the pharmacy department. Independent second analyses are additionally carried out for Asian products, either by a European importer or by an external WHO-accredited laboratory.