Building a Phase III Company's First Sterile Manufacturing Facility
A Phase III biopharmaceutical company required comprehensive engineering support to qualify their new sterile manufacturing facility, establish quality systems, and secure a Contract Manufacturing Organization for fill & finish operations.
Industry
Biopharmaceutical
Service Type
Full CQV + QMS + CMO
Outcome
Facility Qualified & Operational
Scope of Work
Facility Qualification
- Clean rooms — IQ/OQ/PQ
- HVAC system qualification
- WFI system qualification
- Autoclave qualification
- Filling line qualification
- Washing machine qualification
- BMS qualification
Quality & Operations
- Quality and engineering SOPs
- Maintenance instructions
- QMS implementation (Dot Compliance)
- Environmental monitoring setup
- CMO identification for Fill & Finish
- Protocol writing, review, and approval
Impact
This engagement demonstrates the "one stop shop" value of 10AR — a single expert providing coherent, integrated engineering support across the entire spectrum of needs for a company building its manufacturing capability for the first time. Instead of coordinating multiple consultancies with different methodologies and communication gaps, the client received consistent, unified guidance from facility qualification through operational readiness.
Building a New Sterile Facility?
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