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‍Top FDA Observations in 2023

This article serves as a curated snapshot of the FDA observations made in 2023, offering a concise yet insightful overview of the trends, challenges, and opportunities faced by pharmaceutical companies. 

Analysis of the Most Common GMP Violations

Procedures Not in Writing or Fully Followed (Quality Control Unit)

Cite ID: 1105; 1361; 1215; 4402
Frequency: 309 observations

Impacted Departments:

• Quality Control
• Production

Impacted Processes:

• Quality System Management
• Document Control
• Training and Competency Assurance

Recommendations:

• Establish Robust Written Procedures: Ensure comprehensive documentation of all operational and quality control procedures.
• Regular Training Programs: Implement ongoing training for staff to reinforce the importance of adherence to established procedures.
• Quality System Audits: Conduct periodic audits to identify non-compliance and implement corrective actions promptly.

Lack of Cleaning, Maintenance, and Sanitizing Procedures

Cite ID: 1213; 1452; 1451; 1450
Frequency: 183 observations

Impacted Departments:

• Maintenance
• Production
• Quality Assurance

Impacted Processes:

• Equipment Cleaning and Sanitization
• Maintenance Scheduling
• Validation of Cleaning Processes

Recommendations:

• Comprehensive Cleaning Protocols: Develop detailed cleaning and maintenance schedules, including sanitization processes.
• Validation of Cleaning Processes: Ensure the effectiveness of cleaning procedures through rigorous validation.
• Training and Awareness: Increase awareness and training regarding the importance of equipment maintenance and cleanliness.

Scientifically Sound Laboratory Controls

Cite ID: 3603
Frequency: 84 observations

Impacted Departments:

• Quality Control Laboratory
• Research and Development

Impacted Processes:

• Laboratory Testing Procedures
• Control of Laboratory Equipment
• Data Integrity and Documentation

Recommendations:

• Strengthen Laboratory Controls: Enhance the scientific rigor of laboratory testing procedures and controls.
• Equipment Calibration and Maintenance: Ensure all laboratory equipment is regularly calibrated and maintained.
• Documentation and Data Integrity: Prioritize thorough documentation and uphold the highest standards of data integrity.

Lack of Control Procedures to Monitor and Validate Performance

Cite ID: 3585
Frequency: 48 observations

Impacted Departments:

• Quality Assurance
• Production

Impacted Processes:

• Performance Qualification
• Continuous Process Verification
• Monitoring of Critical Process Parameters

Recommendations:

• Implement Comprehensive Monitoring Procedures: Establish and document procedures for continuous monitoring and validation of production processes to ensure consistent performance.
• Performance Validation: Regularly conduct performance validation studies to verify that processes remain in a state of control.
• Training on Process Monitoring: Enhance training programs to ensure personnel are competent in monitoring techniques and understand the importance of validation activities.

Calibration/Inspection/Checking Not Done

Cite ID: 1434; 4342
Frequency: 28 observations

Impacted Departments:

• Maintenance
• Quality Control

Impacted Processes:

• Calibration of Instruments and Equipment
• Routine Inspection and Maintenance
• Quality Checks

Recommendations:

• Strict Calibration Schedule: Adhere to a strict schedule for the calibration and routine inspection of all equipment and instruments.
• Documentation of Calibration Activities: Ensure comprehensive documentation of all calibration, inspection, and maintenance activities.
• Regular Training on Equipment Handling: Provide regular training for staff on the correct handling, calibration, and maintenance of equipment to prevent lapses in compliance.

Inadequate Measures to Prevent Cross-Contamination

Cite ID: 1274
Frequency: 8 observations

Impacted Departments:

• Production
• Quality Assurance

Impacted Processes:

• Manufacturing Process Design
• Cleaning Validation
• Facility Layout and Airflow Management

Recommendations:

• Review and Enhance Containment Strategies: Implement more robust containment and cross-contamination prevention strategies, including facility and equipment design considerations.
• Strengthen Cleaning Validation Programs: Ensure cleaning validation studies are comprehensive and effectively demonstrate the prevention of cross-contamination.
• Employee Training on Contamination Control: Increase training efforts focused on contamination control practices and the importance of preventing cross-contamination.

Hazardous Drugs, Prevention of Cross-Contamination

Cite ID: 18938
Frequency: 8 observations

Impacted Departments:

• Safety and Compliance
• Production
• Quality Assurance

Impacted Processes:

• Handling of Hazardous Drugs
• Environmental Monitoring
• Personal Protective Equipment (PPE) Usage

Recommendations:

• Establish Strict Handling Protocols for Hazardous Drugs: Develop and implement comprehensive guidelines for the safe handling of hazardous drugs to prevent cross-contamination.
• Enhance Environmental Monitoring Programs: Utilize environmental monitoring to detect and prevent cross-contamination risks in areas where hazardous drugs are handled.
• Mandatory PPE Training: Ensure mandatory training on the proper use of PPE for all employees handling or exposed to hazardous drugs, emphasizing the prevention of cross-contamination.

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