Your Partner in Meeting the Pharmaceutical Regulations
Automating your pharmacy involves more than just installing a machine. It requires a controlled environment and adherence to cleaning protocols and quality standards. BIC Medical guides you through this entire process, ensuring you meet all regulatory requirements with confidence.
During a demonstration we can tell and show you more.
QA Handbook & SOP's
Don't reinvent the wheel. We provide an example of what your Quality Assurance Handbook can look like; tailored to automated blistering. This includes Standard Operating Procedures (SOPs) for a wide variety of steps in the process.
- Standardized Protocols: Clear instructions for machine operation, cleaning, and maintenance.
- Customizable: Templates that can be easily adapted to your specific pharmacy workflow.
- Compliance: Designed to meet pharmaceutical regulations.
Expert Room Design & Setup
A compliant workflow starts with the right room layout and technical measures to fulfill the Class D Cleanroom requirements. Our experts advise you on the optimal design of your blistering room to ensure efficiency and hygiene.
- Layout Advice: We help you position machines, workstations, and storage for optimal flow.
- Requirements: Guidance on floor, wall, and ceiling specifications to meet hygiene standards.
- Access Control: Advice on securing the production area.
- Cleanroom: Support in fulfilling the Cleanroom Class D requirements.
Audit Support & Authority Communication
Facing an inspection can be stressful. BIC Medical stands by your side. We help you support you in answering questions from controlling authorities (such as the IGJ, Pharmazierat, or ARS).
- Preparation: Explanations and a nation wide view on local requirements
- Documentation: We provide examples so documentation can be made in order.
- Representation: We can assist in formulating technical answers to regulatory inquiries and be present for meetings.
Simple but Effective Air Monitoring
Medication packaging requires a clean environment. Our Simple but Effective air monitoring systems can measure particle levels, temperature, and humidity in your production room.
- Real-time data: View the status of your production environment at any time.
- Reporting: Store measurements for your quality logs and inspections.
Ready to Work Smarter
Discover how our service model can transform your pharmacy. Schedule a free demo and let us create a custom proposal.