Insights into our project experience: Successful implementation of quality assurance agreements (QAA) in the pharmaceutical industry
As part of a project for a pharmaceutical manufacturer and its contract manufacturer, we demonstrated our expertise in the implementation of quality assurance agreements (QAA). The aim of the project was to optimize the quality assurance processes and ensure compliance with the current GMP guidelines.
The project was implemented under challenging conditions, which were characterized by strict regulatory requirements and tight schedules. Our team of experienced GMP consultants and QA specialists developed tailor-made solutions, including the creation, review, updating and negotiation of quality assurance agreements, delimitation of responsibility agreements (VAV), technical agreements and QP agreements – in both German and English.
Close coordination with the client’s internal departments and external contractual partners was a key success factor. Thanks to targeted project management and precise negotiating skills, time-critical contracts were concluded on schedule. We also optimized relevant processes, revised SOPs and templates, thereby achieving significant efficiency gains.
Our expertise in supplier management and supplier qualification was crucial to the success of the project. In addition, we ensured sustainable implementation and compliance with regulatory requirements through targeted induction and training of the teams.
The successful implementation of the project not only led to a noticeable improvement in quality assurance, but also to a deepening of cooperation with the customers. This example illustrates how even complex challenges can be overcome with a clear strategy, sound expertise and a well-coordinated team.
VITA
- Senior Consultant
- Auditor
- Trainer
- Biochemiker
- Projektplanung, Projektmanagement und Beratungen im GMP-Bereich
- Erfahrung in der Herstellung, Qualitätskontrolle und Qualitätsmanagementprozessen für pharmazeutische Produkte
- Implementierung und kontinuierliche Verbesserung von Qualitätsmanagementsystemen und Prozessen
- Umsetzung von Regularien und Standards nach GxP, ICH, ISO, EP, CFR, AMWHV
Fokus: Qualitätskontrolle & Qualitätssicherung in der Pharmaindustrie
