FDA GMP Requirements for Drug Manufacturing

FDA GMP Requirements for Drug Manufacturing

Understanding FDA cGMP requirements is essential for pharmaceutical manufacturing.

Key cGMP Requirements

Personnel

• Adequate education, training, and experience
• Written procedures and responsibilities
• Hygiene and health requirements

Buildings and Facilities

• Suitable size, construction, and location
• Proper lighting, ventilation, and utilities

Production and Process Controls

• Written procedures for all operations
• In-process controls and testing
• Documentation of all activities

Common Inspection Findings

1. Failure to follow written procedures
2. Inadequate investigation of failures
3. Poor documentation practices
4. Insufficient validation
5. Contamination control issues

Preparing for FDA Inspection

• Maintain inspection-ready status
• Train employees on inspection conduct
• Have documentation readily available