The facility tour is a critical component of the FDA inspection process. It allows inspectors to directly observe operations, evaluate the condition of the facility, and assess compliance with regulatory standards. This part of the inspection is designed to provide inspectors with a first-hand view of the manufacturing processes, quality control measures, and the overall state of the facility.
Key Areas of Focus During the Facility Tour
Cleanliness and Sanitation: Inspectors assess the general cleanliness of the facility, including production areas, storage rooms, and laboratories. This evaluation includes the effectiveness of sanitation procedures, contamination control measures, and maintenance of aseptic conditions in sterile manufacturing areas.
Equipment and Machinery: The condition, maintenance, and calibration of equipment and machinery are scrutinized. Inspectors verify that equipment is suitable for its intended use, properly maintained, and calibrated as per regulatory requirements and manufacturer specifications.
Production Processes: Observing the actual production processes is vital. Inspectors review the adherence to validated processes, batch records, and SOPs during manufacturing. This includes monitoring of critical process parameters, handling of raw materials, and in-process controls.
Quality Control Laboratories: The operation of quality control (QC) laboratories is a significant aspect of the tour. Inspectors examine the laboratory facilities, equipment, and records to ensure that QC testing is conducted properly and in compliance with regulatory standards.
Storage and Warehousing: The conditions and practices in storage areas for raw materials, in-process materials, and finished products are evaluated. This includes checking for proper labeling, segregation, temperature control, and security measures.
Record Keeping and Documentation: While touring the facility, inspectors will observe how records are maintained and accessed during production. This includes logbooks, equipment usage records, and cleaning logs.
Employee Practices and Behaviors: The inspectors observe the practices and behaviors of employees in the facility. This includes their adherence to SOPs, use of personal protective equipment, and overall conduct in production and controlled areas.
How the Tour Influences the Inspection Outcome
Direct Observation: The facility tour offers inspectors the opportunity to make direct observations, which can either corroborate or contradict the documentation provided.
Identifying Discrepancies: Any discrepancies between documented procedures and actual practices observed during the tour are noted. These discrepancies can lead to further investigation or questioning.
Assessing Compliance in Real-Time: The tour allows inspectors to assess compliance in real-time, providing a clearer understanding of the facility’s operational effectiveness and adherence to cGMP.
Preparing for the Facility Tour
Mock Inspections: Conducting mock inspections can help identify potential issues before an actual FDA inspection.
Employee Training: Ensuring that all employees are aware of proper procedures and protocols and understand the importance of compliance during the inspection.
Facility Maintenance: Regular maintenance and upkeep of the facility, equipment, and storage areas to ensure they are in optimal condition.
Documentation Accessibility: Ensuring that relevant documents and records are readily accessible and up-to-date.
Here is a detailed look at the types of documentation that the FDA typically reviews:
- Standard Operating Procedures (SOPs)
Purpose: SOPs are detailed, written instructions to achieve uniformity in the performance of a specific function.
Contents: They include procedures for all significant processes and operations in the facility, like manufacturing, quality control, cleaning, maintenance, and handling of materials.
- Batch Production Records
Purpose: These records provide a history of each batch of product, including its production and control.
Contents: They contain details about the batch, including its formulation, the raw materials used, processing steps, in-process controls, and the personnel involved.
- Quality Control Records
Purpose: To document all quality control activities.
Contents: These records include test results, analysis reports, calibration of instruments, and validation of test methods.
- Validation Documentation
Purpose: Validation documents demonstrate that processes, methods, and systems consistently produce results meeting predetermined acceptance criteria.
Contents: They encompass process validation, analytical method validation, and equipment validation reports.
- Training Records
Purpose: To ensure that personnel are adequately trained for their roles.
Contents: Records of employee training sessions, including topics covered, trainers’ qualifications, and attendees’ lists.
- Equipment Maintenance and Calibration Records
Purpose: To demonstrate that equipment is appropriately maintained, calibrated, and in proper working condition.
Contents: Logs of maintenance activities, calibration schedules, and records of any repairs or adjustments.
- Environmental Monitoring Data
Purpose: For facilities manufacturing sterile products, environmental monitoring is crucial.
Contents: Data on air quality, surface cleanliness, temperature, humidity, and particulate counts in cleanrooms.
- Change Control Records
Purpose: To document any changes made to processes, equipment, or materials that might affect product quality.
Contents: Descriptions of the change, impact assessments, and approvals.
- Complaint Files
Purpose: To record any complaints regarding the quality of the products and the subsequent investigations.
Contents: Details of the complaint, investigation process, findings, and any corrective actions taken.
- Auditing and Self-Inspection Reports
Purpose: To demonstrate ongoing commitment to quality assurance.
Contents: Internal audit reports, findings, recommendations, and follow-up actions.
- Stability Testing Data
Purpose: To ensure the product’s stability over its shelf life.
Contents: Results of stability tests conducted as per defined schedules.
- Regulatory Submission Documentation
Purpose: For new drug applications, this documentation is crucial.
Contents: Drug Master Files (DMFs), submission data for regulatory approval, and any correspondence with regulatory agencies.
The facility tour is more than just a walkthrough; it’s a comprehensive evaluation of the operational, procedural, and compliance aspects of a pharmaceutical api manufacturing facility. By understanding the importance and depth of this phase, facilities can better prepare for FDA inspections, ensuring that they accurately reflect the commitment to quality and regulatory adherence.