Location: Chongju, KO
Area: N/A
Project Cost: N/A
Bio-containment level: N/A
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PharmEng was engaged as an international compliance consultant to help prepare for the Client’s first-ever EU submissions.
Responsibilities:
- QbD / technology transfer consultancy
- Cleaning validation advisory
- Process validation advisory
- Equipment validation review
- Process scale-up and site transfer advisory, technology transfer plan
- Process development protocols and DoE review & advisory
- Cleaning validation and process validation drafting, review & advisory
- Facility and equipment validation review & advisory
Client has since successfully scaled up for commercial-scale production and subsequently passed EU GMP audit from an EU Qualified Person.
Location:
Chongju, KO
Area:
N/A
Project Cost:
N/A
Bio-containment level:
N/A
Share:
