Standard Operating Procedure for Quality Inspection Conveyor
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Quality Inspection Conveyor used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and efficient inspection of product quality.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Quality Inspection Conveyor in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Quality Inspection Conveyor as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and recording the quality of products passing through the conveyor.
Maintenance Personnel: Responsible for maintaining the Quality Inspection Conveyor in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Quality Inspection Conveyor for cleanliness and integrity before use.
4.1.1.2 Ensure all belts, rollers, and sensors are secure and functional.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Quality Inspection Conveyor and surrounding area.
4.1.2.2 Set up the machine for the required product specifications as per batch requirements.
4.1.2.3 Ensure the inspection sensors and cameras are properly calibrated and functional.
4.2 Operation
4.2.1 Inspection Process
4.2.1.1 Start the Quality Inspection Conveyor and ensure it is running smoothly.
4.2.1.2 Place products on the conveyor belt for inspection.
4.2.1.3 Monitor the inspection process to ensure accurate detection of defects and quality issues.
4.2.1.4 Adjust the inspection settings if necessary to maintain inspection accuracy.
4.2.2 Quality Control
4.2.2.1 Periodically check inspected products for accuracy and consistency of inspection results.
4.2.2.2 Document all QC checks and results.
4.2.2.3 Take corrective actions if deviations are observed.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the inspection process and ensure all products are correctly inspected.
4.3.1.2 Clean and sanitize the belts, rollers, and machine components.
4.3.1.3 Perform post-operation checks to ensure no residual product or contamination in the machine.
4.3.2 Maintenance
4.3.2.1 Clean and inspect the machine components after each batch.
4.3.2.2 Perform preventive maintenance on belts, rollers, sensors, and cameras.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch records for each inspection batch
Maintenance records
Calibration records for inspection settings
7) Reference, if any
Manufacturer’s manual for the Quality Inspection Conveyor
Pharmacopeial guidelines for pharmaceutical inspection processes
8) SOP Version
Version 1.0