Analytics and Quality Assurance
The forum for innovations in analytics and quality assurance
Pharmaceutical analytics and quality assurance are key elements in providing patients with high-quality medications. Regulatory authorities constantly publish new guidelines. In daily work, it's becoming increasingly challenging to keep track of the current state of regulatory requirements and to assess their implications for daily tasks.
It's no wonder, then, that the APV Analytical and Quality Assurance focus Group offers numerous seminars on current GMP topics.
Our focus group provides a forum for discussing current issues and developing solution proposals in the field of analytics and quality assurance.
During their regular meetings, the focus group evaluates new guidelines and current trends in the field of analytics and quality assurance. The diversification of the focus group's members plays a significant role here. Members come from regulatory authorities, pharmaceutical companies of various sizes and orientations, service providers, contract manufacturers, and universities. This ensures that topics are discussed from various perspectives.
The focus group organizes international seminars and workshops where there's an exchange of experiences between experts and participants. Workshops on "Hot Topics," especially those organized in collaboration with other focus groups, are particularly popular. Task force groups are established for current topics, allowing APV members to engage in intensive exchanges. Participation in task force groups is free for APV members. Additionally, the focus group hosts expert meetings, which often lead to position papers.
The main subject areas
Aus dem Bereich Qualitätssicherung:
- National and international compliance guidelines and trends
- Quality systems
- Continuous process improvement
- Starting materials
- Supplier qualification/audits
- Risk management
- Product lifecycle
- Data integrity
From the field of analytics:
- Innovative analytical methods and procedures
- Automation of analytical methods
- Stability studies
- Statistics Validation and transfer of analytical methods
- Quality-by-design for analytical methods
Our goal is to develop pragmatic solutions for the industry.
We primarily focus on aspects of analytics and quality assurance that are relevant for daily work in the pharmaceutical industry. We see our role as shaping opinions on current issues through position papers as APV opinion leaders. In doing so, we aim to create a leading European forum that promotes the exchange of experiences and discussions on trends in analytics and quality assurance.
