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FDA Compliance Checklist
Quality Management System
Establish a documented quality policy and objectives.
Implement a system for quality audits and inspections.
Ensure proper training and competency of personnel.
Maintain records of quality management activities.
Conduct regular management reviews of the quality system.
Production and Process Controls
Develop and document standard operating procedures.
Implement process validation and verification protocols.
Monitor production processes and control variables.
Establish corrective and preventive action procedures.
Maintain equipment calibration and maintenance records.
Documentation and Record Keeping
Ensure all records are accurate, complete, and legible.
Implement a system for document control and revisions.
Retain records for the required duration specified by regulations.
Ensure electronic records comply with 21 CFR Part 11.
Protect records from loss, damage, and unauthorized access.
Labeling and Packaging Controls
Ensure labels meet regulatory requirements and are accurate.
Implement procedures for label review and approval.
Maintain control over labeling changes and revisions.
Verify that packaging prevents contamination and damage.
Ensure traceability and control of labeling components.
Complaint Handling and Adverse Event Reporting
Establish a system for receiving and reviewing complaints.
Evaluate complaints to determine if an investigation is needed.
Report adverse events to the FDA as required.
Maintain records of complaints and investigations.
Implement procedures for corrective actions based on complaints.
