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Our Quality Assurance department is responsible for:
- Ensuring compliance with cGMP and international regulatory
requirements
- Review and approval of all manufacturing documentation
- Materials and vendor assurance
- Adherence to customer quality agreement
- Validation
- Product disposition
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Our quality systems are under continuous assessment through
a combination of internal, customer and regulatory authority
audits.
Qualified Person (QP) release
For your commercial manufacture, Fujifilm Diosynth Biotechnologies
has its own Qualified Person (QP) ready to certify that your
Active Pharmaceutical Ingredient (API) is suitable for release
to market. For European markets and the biologics industry
this is a legal requirement. Having an on-hand QP within Fujifilm
Diosynth Biotechnologies provides our customers with a huge
advantage when beginning their commercial manufacture. |
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