Quality
Quality and Compliance
Compliance with Good Manufacturing Practices (GMP) is a crucial criterion for pharmaceutical production to ensure the protection of patient health and the provision of high-quality and effective drugs. The STAMERK facility operates according to GMP and Good Distribution Practices (GDP).
All necessary resources for GMP are provided, including:
- Qualified and trained personnel,
- Appropriate facilities and space,
- Suitable equipment and services,
- Correct materials, containers, and labels,
- Procedures and instructions approved by the Pharmaceutical Quality System,
- Adequate storage and transportation.
Documentation
We understand that our customers require consistency, traceability, and reliability. To reveal, control, monitor, and record all activities directly or indirectly impacting the quality of medical products, we create documentation.
Our documentation, reaching every part of our business, forms the basis of our customer service guarantee while maintaining compliance with regulatory requirements. All SOPs and documentation are verified by our Quality team, ensuring seamless integration with the current operational needs of our stability storage service.
Training
Continuous training is provided to all STAMERK personnel to ensure they possess high qualifications to meet on-site requirements. The effectiveness of training in practice is periodically evaluated through both internal and external audit programs.
Environmental Monitoring Compliance
Compliance and visibility are at the core of all processes implemented at STAMERK. Therefore, our services are meticulously verified and subjected to document control, managing processes with the best storage monitoring and reporting practices.
Rooms
STAMERK stability and cold rooms are state-of-the-art. They undergo comprehensive qualification during installation, with completion of installation, operational, and performance qualifications. They are regularly re-qualified to ensure they meet the requested performance requirements.
Validation is a documented program ensuring that our systems consistently produce results conforming to pre-established acceptance criteria. The validation process follows the GAMP5 V-model methodology, confirming user needs are fully met through the implementation of IQ-OQ-PQ tests.
Monitoring System
Temperature and humidity conditions are continuously monitored using a monitoring system compliant with FDA (21 CFR Part 11), and measurements are recorded.
STAMERK independently monitors each climate-controlled storage area, providing real-time information to the staff. In climate-controlled storage areas, if any deviation occurs due to working conditions, our staff is immediately informed through alarms generated by the 24/7 monitoring system. This ensures immediate intervention by the personnel. Additionally, rooms independently create alarms to alert our staff both audibly and visually.
Backup System
A backup system is essential to ensure data protection. Our facility is supported by an uninterruptible power supply and an automatic transfer switch with a backup generator to handle any power outage or flow.
Data for all storage areas is stored in real-time within our facility, and this data is backed up outside the facility at specific intervals. The integrity, accuracy, and data restore capacity of the backed-up data are controlled during the validation process and regularly monitored.
