Biotech Manufacturing Capacity Evaluation Checklist Form
Biotech Manufacturing Capacity Evaluation Checklist: Use this form to assess your biotech manufacturing site's production capacity and readiness across key operational areas.
Current operational status
*
Fully operational
Partially operational
Not operational
Available production lines/equipment
*
Fermentation
Purification
Formulation
Filling/Packaging
Other
Current staffing level (number of staff available for production)
*
Number of shifts currently operated per day
*
Average daily throughput (units produced per day)
*
Typical batch size
*
Current inventory/materials availability
*
Sufficient for planned production
Limited but manageable
Insufficient—risk of shortage
Quality/testing process bottlenecks (select all that apply)
*
Analytical testing delays
Release hold-ups
Equipment downtime
None
Other
Near-term constraints impacting capacity (select all that apply)
*
Staffing shortages
Supply chain delays
Regulatory issues
Equipment maintenance
Other
Assessment matrix: Please rate each area below for current readiness (1 = Not Ready, 5 = Fully Ready)
*
Rows
1
2
3
4
5
Production Equipment
1
2
3
4
5
Staffing
6
7
8
9
10
Materials/Inventory
11
12
13
14
15
Quality/Testing
16
17
18
19
20
Logistics
21
22
23
24
25
Additional comments or notes
Submit Evaluation
Should be Empty: