Quality
TRADITION OF QUALITY
Quality is important to Bioglan
All manufacturing activities are regulated by the quality system and controlled by the Quality Assurance department. The quality system fulfills the EU GMP (Good Manufacturing Practices) requirements as well as the ISO 13485 standard for Medical Devices. Our manufacturing authorization from the Swedish Medical Products Agency allows us to produce non-sterile semi-solid and liquid products, whether at pilot scale for clinical trials or at full-scale to supply a large commercial market. We can even be your QP release site for other types of products.- The facilities are regularly inspected for GMP compliance by MPA.
- The facilities are regularly inspected for ISO 13485 compliance by BSI Assurance UK Ltd.
- The facilities are regularly inspected for GMP compliance by international customers.
- Bioglan has an in-house QP.
The quality policy at Bioglan is based upon
- Long term relationships and confidence with customers.
- Continuous training of personnel.
- Follow-ups of established work to gain knowledge in order to develop further.
- Up-to-date on new and changed regulations and scientific progress.
Quality assurance
Quality is brought into the project from the start and QA support is present throughout the entire project process.The quality assurance system at Bioglan covers:
- Documentation control
- Deviation/Out of specification (OOS) / Corrective and preventive actions (CAPA) systems
- Change control handling
- Release of products
- Equipment / facility / utility / process / computer qualification / validation
- Internal/external Inspections
- Compliant and recall handling
- Product quality review
- Supplier and contractor qualification
- Health checks on personnel
- Quality risk management
- Regulatory support
Quality control
We meet the quality control requirements that your product needs
The Quality Control laboratory ensures compliance to specifications, from raw material to the finished product. The laboratory is equipped with state of the art equipment appropriate for topical products.
Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines are also performed.
The quality control system at Bioglan covers:
- LIMS (Laboratory information management system)
- Temperature monitoring system (Boomerang)
- All analytical equipment is included in our calibration program
- New analytical equipment is evaluated with our IQ/OQ/PQ protocols
- Complete data traceability
- Full secondary data review
- Implementation of pharmacopoeias
Bioglan utilises a broad range of analytical techniques including:
- High Performance Liquid Chromatographs (HPLC) with UV, DAD and RI detectors
- Gas Chromatography (GC) with FID detector
- FTIR
- Viscometer
- Densitometer
- Melting point
- Conductivity
- Titration equipment
- Spectrophotometer
- Refractometer
- Microscopy