Biomedical Engineering Reference
In-Depth Information
Key performance indicator:
RESEARCH & DEVELOPMENT LABORATORY ACTIVITIES
(STABILITY/METHOD DEVELOPMENT/NEW PRODUCT)
Report for the month of
, year
Formulation Laboratory
Serial No.
Description
Total No.
1
Experimental batches
2
Stability/pilot/batches
3
Validation batches
4
Master formula (new/updated)
5
Problem resolution and formula optimization
Analytical La
boratory
Serial No.
Description
Total No.
1
Standard test method
2
Test method validation
3
Comparative study (in vitro bioequivalence study)
4
Sample analysis (registration & tender)
5
Stability study (formal & ongoing)
6
Problem resolution
Packaging Labora
tory
Serial No.
Description
Total No.
1
Artwork & text approval
2
Initial sample for registration
3
Final packs for registration approval (packaging
material specification)
4
Primary packaging material
Documentation
Serial No.
Description
Total No.
1
Regulatory documents (development pharmaceutics,
Mfg, flow chart)
2
Updating specification
3
Technical support for regulatory agency's queries
4
Raw material specification, purchase specification
Information provided by:
Name and signature:
Date:
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