Quality assurance and control forms an integrated part of the analyses performed and of the work of ALS Scandinavia as a whole.
Quality assurance (QA) is the generic term for all activities required to maintain quality in the analytical results. The QA activities affect many fields such as organization, training, equipment, methods, etc.
The QA is organized and documented within the laboratory´s QA system. The QA system is a prerequisite for laboratory accreditation. The accreditation is a third-party acknowledgement of competence and is comparable to ISO 9000 certification in industry. For a laboratory to be accredited, compliance with international QA standards must be confirmed both by an initial assessment and by recurrent audits. In Sweden, accreditation and control of accredited laboratories is the responsibility of SWEDAC. SWEDAC cooperates internationally with other accreditation bodies, which implies that its accreditation is accepted in several other countries.
Accreditation by SWEDAC pertains to specific analytical methods. Non-accredited analyses are also subject to QA and many parts of the QA system are common to all analyses. However, accredited analyses must meet special requirements e g regarding documentation.
|GMP (find more information below)|
More information about our GMP certification:
- Extension of GMP certificate
For sites in the European Economic Area (EEA), GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2022. Good manufacturing practice | European Medicines Agency (europa.eu)
- The GMP certification applies to human medicines
The new EU regulation for veterinary medicinal products 2019/6, which was applied on 28 January 2022, means that we are currently not GMP certified for veterinary medicinal products.
- Inspections and confidential information
We are routinely inspected by pharmaceutical companies and we meet our customers' requirements regarding GMP routines and confidential treatment of information. The pharmaceutical laboratory in Sollentuna also participates in testing comparisons.
- Quality control
- Control charts
- Validation of analytical methods
- Uncertainty in measurement
- Control of subcontractors
- About limits of detection and quantification
- Chain of custody