Quality Management (GXP)
From Quality Management System (QMS) to GMP Inspection
Pharma Expertise Consulting is a service provider for quality management, quality control and quality assurance.
As a pharmaceutical company you need a Quality Management System (QMS) in accordance with Guidelines for Good Practice (GxP) including Guidelines for Good Manufacturing Practice (GMP). 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) or the continuous monitoring of safety Good Pharmacovigilance Practice (GVP).
Qualified persons (QP) are responsible for ensuring compliance with these guidelines and for carrying out inspections by the supervisory authorities. In the field of drug safety, they are called Qualified Persons for Pharmacovigilance (QPPV, in Germany: Stufenplanbeauftragter nach § 63a Arzneimittelgesetz AMG).
The Qualified Person is also responsible for the release of medicinal products through 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.
Our quality management services:
- Establishment of a quality management system (QMS) with standard operating procedures (SOP), preparation of the QM manual.
- Quality management system auditing (gap analysis)
- Performance of self-inspections
- Function of a Quality Management Representative or Wholesale Representative according to § 52 AMG
- Function of a Qualified Person (also temporary)
- Audits (accompanying audits by authorities)
(Begleiten von Behördenaudits)
For active pharmaceutical ingredients and starting materials, audits (monitoring of GMP compliance of manufacturers) are also necessary. Through our network, we are happy to arrange for qualified auditors and third-party audit reports.
Our GMP-certified partner laboratories also test pharmaceuticals (pharmacopoeia testing) and related products like dietary supplements and medical devices using modern instrumental analysis (quality control).
We are happy to support you. Just contact us!