Quality

The analyses from our analytical laboratory are typically used in registration documentation. Consequently, the generated data have to live up to official  standards, and the laboratory quality system must comply with the quality demands of the customer. Every task is carefully stipulated to meet the individual customer’s requirements for quality control, enabling easy integration of data into the customer’s documentation system.

Particle Analytical is approved as a GMP laboratory by the Danish Medicines Agency (DMKA) and registered with the FDA. The approval by DMKA applies for both human and veterinarian medicinal products. Please contact us to request the certificates.

Our quality systems comprises:
  • Documented quality assurance system
  • Qualified analytical instruments
  • Log books for all instruments
  • Document control
  • Self inspections

Accreditations

  • Danish Medicines Agency
    Particle Analytical is approved as a GMP laboratory by the Danish Medicines Agency. Particle Analytical also has permission to handle controlled substances (contact us for more information).
  • FDA
    Particle Analytical is registered with the FDA and has been inspected several times.

Validations

We perform validations in all areas within solid state characterisation according to current  ICH guideline: Validation of analytical procedures, Q2(R1). Validation is required for all analytical methods used for regulatory purpose. Furthermore revalidation may be necessary in the following circumstances:

  • Changes in the synthesis of the drug substance;
  • Changes in the composition of the finished product;
  • Changes in the analytical procedure.
The degree of revalidation required depends on the nature of the changes. We can advice you on the extent of revalidation needed in your situation.

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