Investigator Details
Emmanuel Adu-Gyamfi
Investigation Details
Last Issued Date:
June 29, 2023
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Emmanuel Adu-Gyamfi meticulously reviews documentation and validation processes, focusing on the clarity and specificity of instructions. He pays particular attention to the details of product handling, facility cleaning, and storage conditions within the manufacturing facility.
Profile:
Emmanuel Adu-Gyamfi is a detail-oriented FDA auditor who places significant emphasis on document management and process validation. He expects clear and specific instructions in standard operating procedures (SOPs) related to product handling, facility cleaning, and water for injection (WFI). Additionally, he scrutinizes process validation documentation for detailed information on the storage of products within the manufacturing facility.
Top Process Types:
- Data Integrity
- Document Management
- Process Validation
- Sample Testing
- Stability Studies
