Standard Operating Procedure for Manufacturing Process Control in Otic Manufacturing Unit
1) Purpose
To establish procedures for controlling and monitoring the manufacturing processes of Otic (Ear) Dosage Forms to ensure consistency, quality, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the manufacturing processes within the Otic manufacturing facility.
3) Responsibilities
Production Supervisors: Responsible for overseeing and controlling the manufacturing processes.
Quality Assurance (QA) Department: Responsible for monitoring and verifying process controls and parameters.
Engineering Department: Responsible for maintaining and calibrating process equipment.
4) Procedure
4.1 Preparation and Setup
4.1.1 Pre-Production Checks
4.1.1.1 Conduct pre-production checks to ensure all equipment is clean, calibrated, and ready for use.
4.1.1.2 Verify availability of raw materials and batch records.
4.1.2 Line Clearance
4.1.2.1 Perform line clearance to ensure no residual materials from previous runs are present.
4.1.2.2 Document line clearance activities in batch records.
4.2 Process Monitoring
4.2.1 Equipment Calibration
4.2.1.1 Calibrate manufacturing equipment according to approved procedures and schedules.
4.2.1.2 Record calibration activities and update calibration logs.
4.2.2 Process Parameters
4.2.2.1 Set and monitor critical process parameters (e.g., temperature, pressure, mixing speed) as per batch record instructions.
4.2.2.2 Use validated processes and equipment settings to ensure reproducibility.
4.3 In-process Controls
4.3.1 Sampling and Testing
4.3.1.1 Conduct in-process sampling and testing at specified intervals according to approved procedures.
4.3.1.2 Document results and compare against acceptance criteria.
4.3.2 Deviation Handling
4.3.2.1 Address any deviations from established process parameters promptly.
4.3.2.2 Initiate corrective actions as per deviation handling SOP.
4.4 Documentation and Batch Records
4.4.1 Recordkeeping
4.4.1.1 Document all process control activities, including deviations, in batch records.
4.4.1.2 Obtain approvals from QA for critical process stages.
4.4.2 Data Integrity
4.4.2.1 Ensure data integrity and accuracy throughout the manufacturing process.
4.4.2.2 Maintain legible, contemporaneous, and accurate records.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices
6) Documents, if any
Batch records
Calibration logs
In-process control records
7) Reference, if any
GMP guidelines for manufacturing process control in pharmaceutical manufacturing
8) SOP Version
Version 1.0
