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Quality standards

A pharmacist pours a liquid out of a measuring cup.

A pharmacist pours a liquid out of a measuring cup. © action medeor/B. Breuer

An effective Quality Management System enables action medeor to guarantee the consistent high quality of all our medicines.

action medeor is a pharmaceutical entrepreneur and also has a wholesaler’s licence   according to §52a of German pharmaceutical law. The product information labels are edited in up to four languages (English, French, Spanish and Portuguese) and applied to the packagingdrug containers   by the contract manufacturers.

Standard Operating Procedures (SOPs) are in place for all the processes. action medeor undertakes to ensure the quality and safety of drugs. The SOPs are regularly checked and updated by the head of Quality Assurance.

action medeor is subject to inspections of the state authority in charge (District Government of Düsseldorf) that reviews the compliance to regulatory drug guidelines.

Assortment of medicines

The WHO Model List of Essential Medicines forms the basis from which our medicines are selected. Certificates according to the WHO Certification System are available or can be acquired at short notice for most medicines. These “certificate(s) of a pharmaceutical product” contain information about the manufacturer, the GMP-compliant production and the regular inspection by control authorities.

Pre-qualification

The medicines in action medeor’s product range are manufactured by various drug manufacturers in Europe and Asia, and observe the international quality standards and the current guidelines of the British (BP), European (Ph.Eur.) and United States (USP) pharmacopoeias. Every potential manufacturer has to pass the pre-qualification process, before being considered as a supplier for action medeor. The Quality Assurance (QA) department at medeor examines the quality relevant documents such as the manufacturer’s license and Good Manufacturing Practice (GMP) certificates, Site Master File or external audit reports.

All of our contract manufacturers produce according to the WHO-GMP guidelines. The authorities in charge in the respective countries as well as additional international authorities inspect the manufacturers regularly. In addition to that, action medeor conducts audits of the manufacturers together with international pharmaceutical experts.

In the course of the product-specific calls for tender, every potential manufacturer has to fill in a product questionnaire, which is  evaluated by our QA department. Apart from checking compliance to the specifications (mostly Ph.Eur., BP, USP), we inquire about many other details such as stability data, registrations and quality of the Active Pharmaceutical Ingredient (API).

Quality control

Upon receipt of the goods at  action medeor’s warehouse, every product is submitted to strict quality control procedures. First of all the medicines are carefully inspected in the quarantine area on the basis of documented processes. Whenever necessary, additional quality control tests are carried out in WHO-prequalified laboratories. Properly produced and controlled lots are released by the responsible pharmacist. Only then can the medicines be transferred to the main warehouse and will be ready for dispatch.