Pharmaceutical Manufacturer Assessment Form
Evaluate a pharmaceutical manufacturer’s capabilities, quality systems, facility readiness, and follow-up status using this assessment form.
Manufacturer Overview
Company / Legal Name
*
Website / Primary Business URL
*
Headquarters Country / Region
*
Primary Manufacturing Site Location
*
Operational Scope and Capabilities
Primary product categories manufactured
*
APIs
Finished dose forms
Sterile products
Biologics
OTC products
Other
Manufacturing services offered
Formulation
Filling
Packaging
Labeling
Testing
Release
Other
Capacity / volume description
*
Quality and Compliance Assessment
Quality management maturity
*
Initial
1
2
3
4
5
6
7
8
9
Optimized
10
1 is Initial, 10 is Optimized
GMP documentation and traceability
*
Limited
1
2
3
4
5
6
7
8
9
Fully traceable
10
1 is Limited, 10 is Fully traceable
Deviation and CAPA handling
*
1
2
3
4
5
Recent inspection outcome status
*
No recent inspection
Passed
Observations issued
Remediation in progress
Other
Facility, Technology, and Risk Profile
Facility, technology, and controls assessment
*
Rows
Status
Comments
Cleanroom classifications
1
Environmental monitoring
2
Validation/qualification status
3
Data integrity controls
4
Equipment maintenance
5
Supply continuity risk level
*
Low
Moderate
High
Critical
Other
Key constraints or gaps
Assessment Summary and Next Steps
Key Strengths
Key Concerns or Remediation Priorities
Follow-Up Status
*
Proceed
Conditional Review
Needs Additional Information
Submit Assessment
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