Services
Regulatory Support and other Quality Assurance Services
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Analytical quality control services. An appropriate
quality system and analytical methods are critical components
in the development and production of biopharmaceuticals. Our
Quality Assurance (QA) and Quality Control (QC) teams provide
material characterisation, testing and analytical method
development services together with extensive GMP manufacturing
support to guarantee compliance with current rugulations. The
staff is highly qualified and regulary trained according to GMP
guidelines.
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GMP compliance is ensured by:
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A production licence granted by the National Agency of
Medicine
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Regular inspections by the Finnish regulatory
authorities
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Experience with national regulatory authorities,
the FDA and EU
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GLP/GMP documentation
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Equipment and process validation
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Validation of analytical methods according to
appropriate guidelines
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Internal audits of manufacturing and laboratory
facilities and operations
