Quality is important to Bioglan


All manufacturing activities are regulated by the Bioglan 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 MDD/MDR.

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.

  • The facilities are regularly inspected for cGMP compliance by MPA
  • The facilities are regularly audited for ISO 13485 compliance by BSI
  • The facilities are regularly audited for GMP compliance by customers
  • Bioglan has in-house QP

The quality policy at Bioglan is based upon:

  • Long term relationships and confidence with customers
  • Continuous training of personnel
  • Follow-up of established work procedures to gain knowledge and experience for further development
  • 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 Management System at Bioglan covers:

  • Documentation control
  • Deviation/Out of specification (OOS) / Corrective and preventive actions (CAPA) management
  • Change control management
  • QP certification of products
  • Validation and qualification
  • Internal/External Inspections
  • Complaint and recall management
  • Supplier control management
  • Quality risk management

Quality control

We meet the quality control requirements that your product needs.

The Quality Control laboratory ensures compliance to specifications, from starting material to the finished product. The laboratory is equipped with 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 
  • All analytical equipment is included in our calibration program
  • New analytical equipment is evaluated with our IQ/OQ/PQprocess.
  • Complete data traceability
  • Full secondary data review

Bioglan utilizes a broad range of analytical techniques including:

  • High Performance Liquid Chromatographs (HPLC/UPLC) with UV, DAD and RI detectors and LCMS.
  • Gas Chromatography (GC) with FID detector and GC with Head-space.
  • FTIR
  • Viscometer
  • Densitometer
  • Melting point
  • Conductivity
  • Titration equipment
  • Spectrophotometer
  • Refractometer
  • Microscopy

Privacy Preference Center