Standard Operating Procedure for In-process Control and Sampling in Otic Manufacturing Unit

1) Purpose

To establish procedures for conducting in-process controls and sampling during the manufacturing of Otic (Ear) Dosage Forms to ensure product quality, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the manufacturing process within the Otic manufacturing facility.

3) Responsibilities

Production Operators: Responsible for conducting in-process controls and sampling as per SOP.
Quality Control (QC) Department: Responsible for performing testing on in-process samples.
Quality Assurance (QA) Department: Responsible for oversight and verification of in-process controls.

4) Procedure

4.1 In-process Sampling
4.1.1 Sampling Points
4.1.1.1 Identify and mark sampling points within the manufacturing process.
4.1.1.2 Ensure sampling points are representative of critical process stages.

4.1.2 Sample Collection
4.1.2.1 Collect samples at specified intervals or critical process stages.
4.1.2.2 Use appropriate sampling techniques to avoid contamination.

4.2 In-process Controls
4.2.1 Parameter Monitoring
4.2.1.1 Monitor critical process parameters (e.g., temperature, pressure, pH) during manufacturing.
4.2.1.2 Use calibrated equipment and validated methods for parameter monitoring.

4.2.2 Visual Inspection
4.2.2.1 Conduct visual inspections of the product at various stages of manufacturing.
4.2.2.2 Document any deviations or abnormalities observed during inspection.

4.3 Testing and Analysis
4.3.1 Sample Preparation
4.3.1.1 Prepare in-process samples for testing according to approved procedures.
4.3.1.2 Label and identify samples correctly to avoid mix-ups.

4.3.2 Laboratory Testing
4.3.2.1 Submit samples to the QC laboratory for analysis.
4.3.2.2 Perform tests as per specifications outlined in the batch record.

4.4 Data Recording and Documentation
4.4.1 Recordkeeping
4.4.1.1 Document all in-process control activities, including sampling, testing, and results.
4.4.1.2 Maintain accurate and legible records of in-process controls.

4.4.2 Compliance Verification
4.4.2.1 Verify compliance of in-process controls with established specifications and limits.
4.4.2.2 Report any deviations from specifications to QA for investigation.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Sampling plan
Test methods and specifications
In-process control records

7) Reference, if any

GMP guidelines for in-process control and sampling in pharmaceutical manufacturing

8) SOP Version

Version 1.0