Turnkey setup of a new IVD manufacturing facility
A company establishing a new IVD manufacturing facility needed a GMP-compliant, audit-ready plant.
Industry
Medical devices / IVD
Location
India
Services
Manufacturing & Turnkey
Category
Manufacturing & Turnkey
Manufacturing & TurnkeyA company was establishing a new IVD manufacturing facility, but the facility design was not GMP-compliant, there were workflow and material-movement issues, and validation and qualification plans were missing.
IVD Manufacturer
Client Type
Medical devices / IVD
Product Category
India
Target Market
Challenges Faced
- Facility design not compliant with GMP requirements.
- Workflow and material-movement issues.
- Lack of validation and qualification plans.
Our Approach
- Designed a GMP-compliant facility layout suited to the product and process.
- Planned cleanroom classifications and workflows for clean personnel and material movement.
- Supported equipment qualification and validation activities.
- Established the quality and regulatory systems needed for compliant operations.
A clear path, milestone by milestone
GMP-compliant layout
Cleanroom & workflow planning
Equipment qualification
Quality & regulatory systems
What it meant for the client
Facility commissioned successfully.
Audit-ready infrastructure established.
Manufacturing license obtained efficiently.
Key Results
GMP-compliant
Facility layout
Planned
Cleanroom & workflow
Qualified
Equipment & validation
Audit-ready
Infrastructure
Every engagement is led by senior regulatory experts — with transparent milestones, complete documentation, and fixed-scope clarity from day one.
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