Standard Operating Procedure for In-Process Control During Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for conducting in-process controls during the manufacturing of dental dosage forms to ensure product quality and compliance with regulatory standards.

2) Scope

This SOP applies to all stages of manufacturing processes involving dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for conducting in-process controls. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.

4) Procedure

4.1 Sampling Plan

4.1.1 Develop a sampling plan based on manufacturing process steps, critical control points, and regulatory requirements.

4.1.2 Determine sampling points, frequency, and sample sizes based on risk assessment and process validation data.

4.2 Sampling Process

4.2.1 Wear appropriate personal protective equipment (PPE) and follow aseptic techniques during sampling.

4.2.2 Collect samples according to defined sampling procedures and transfer them to the laboratory for analysis.

4.3 Analysis and Testing

4.3.1 Perform physical, chemical, and microbiological tests on in-process samples as per approved test methods and specifications.

4.3.2 Record test results and compare them against acceptance criteria defined in batch records and standard operating procedures.

4.4 Documentation

4.4.1 Document all in-process control activities, including sampling, testing, and results recording.

4.4.2 Maintain batch records and in-process control records