Investigator Details
Samir C Gala
Investigation Details
Last Issued Date
June 8, 2022
No. of 483’s Issued
since 2023
4
Warning Letters Issued
0
Detailed Analysis
Approach:
Samir C Gala adopts a meticulous approach with a strong emphasis on aseptic processing areas and the criticality of environmental monitoring and air supply in maintaining pharmaceutical product quality. He also closely scrutinizes batch testing for drug product expiration dates.
Profile:
Samir C Gala is known for having a strong focus on aseptic processing areas, particularly regarding environmental monitoring and air supply. He also pays great attention to the testing of batches for determining drug product expiration dates.
Top Process Types:
- Environmental Monitoring
- Drug Product Containers & Closures
- Facility Design
- Process Control
- Stability Studies
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