{"id":3479,"date":"2022-03-02T11:46:30","date_gmt":"2022-03-02T11:46:30","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3479"},"modified":"2022-10-27T10:26:44","modified_gmt":"2022-10-27T10:26:44","slug":"quality-management","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/quality-management\/","title":{"rendered":"Quality Management"},"content":{"rendered":"

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Quality Management (GXP)<\/h2>\n

From Quality Management System (QMS) to GMP Inspection<\/h1>\n

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Pharma Expertise Consulting is a service provider for quality management<\/strong>, quality control<\/strong> and quality assurance<\/strong>.<\/p>\n

As a pharmaceutical company you need a Quality Management System (QMS)<\/strong> in accordance with Guidelines for Good Practice (GxP)<\/strong> including Guidelines for Good Manufacturing Practice (GMP)<\/strong>. The GMP rules applicable in the European Union are published in the EU GMP Guide. However, similar EU guidelines also exist, for example, for the wholesale distribution of medicinal products Good Distribution Practice (GDP)<\/strong>\u00a0or the continuous monitoring of safety Good Pharmacovigilance Practice (GVP)<\/strong>.<\/p>\n

Qualified persons (QP)<\/strong> are responsible for ensuring compliance with these guidelines and for carrying out inspections by the supervisory authorities. In the field of drug safety<\/strong><\/a>, they are called Qualified Persons for Pharmacovigilance<\/strong> (QPPV, in Germany: Stufenplanbeauftragter nach \u00a7 63a Arzneimittelgesetz AMG).<\/p>\n

The Qualified Person is also responsible for the release of medicinal products through<\/strong> the final review of the corresponding batch documentation and certification of the batches. The Qualified Person ensures that the certification is covered by the manufacturing and\/or import license.<\/p>\n

Our quality management services:<\/strong><\/p>\n