Standard Operating Procedure for Quality Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedures for ensuring consistent quality monitoring of ocular dosage forms, including eye drops, ointments, gels, and inserts, during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the production and quality assurance of ocular dosage forms within the pharmaceutical manufacturing facility, covering all stages from raw material receipt to final product release.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing the quality monitoring process, reviewing records, and ensuring compliance with regulatory requirements.
Production Department: Responsible for implementing quality monitoring procedures during manufacturing.
Operators: Responsible for performing quality checks and recording data as per this SOP.
Quality Control (QC) Laboratory: Responsible for conducting quality tests on product samples.

4) Procedure

4.1 Establishing Quality Monitoring Parameters

1. Identify critical quality attributes (CQAs) for each ocular dosage form, such as sterility, pH, viscosity, particle size, and active ingredient concentration.
2. Determine acceptable ranges and specifications for each CQA based on regulatory guidelines and product requirements.

4.2 Routine Quality Monitoring

1. Conduct routine quality checks at predefined stages of the manufacturing process, including raw material inspection, in-process monitoring, and final product testing.
2. Use validated methods and calibrated instruments for all