Standard Operating Procedure for Foreign Particulate Matter Testing in Gels

1) Purpose

The purpose of this SOP is to establish procedures for detecting and quantifying foreign particulate matter in gels to ensure product safety and quality.

2) Scope

This SOP applies to the Quality Control (QC) department responsible for performing foreign particulate matter testing on gels manufactured at the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC): Perform foreign particulate matter testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of foreign particulate matter testing procedures and ensure compliance with SOPs and regulatory guidelines.
R&D or Formulation Development: Provide formulation details and method validation support for foreign particulate matter testing.

4) Procedure

4.1 Sample Collection and Preparation
4.1.1 Collect representative samples from finished gel batches with documented batch/lot numbers and production records.
4.1.2 Inspect samples visually for any visible foreign particulate matter before testing.

4.2 Microscopic Examination
4.2.1 Prepare the sample according to SOP for microscopic examination.
4.2.2 Place the sample on a suitable microscope slide and examine under appropriate magnification.
4.2.3 Record and classify any foreign particulate matter found based on size, shape, and composition.

4.3 Filter and Membrane Examination (if applicable)
4.3.1 If specified in procedures, filter the sample through suitable membranes.
4.3.2 Examine the filters under appropriate lighting conditions and record any particulate matter detected.

4.4 Quantification and Documentation
4.4.1 Quantify the foreign particulate matter found in each sample according to company-specific acceptance criteria.
4.4.2 Document all findings, including methods used, observations, and measurements.

4.5 Compliance Assessment
4.5.1 Compare foreign particulate matter test results against predefined acceptance criteria and specifications.
4.5.2 Document compliance or non-compliance with foreign particulate matter limits.

4.6 Reporting and Documentation
4.6.1 Prepare detailed test reports documenting foreign particulate matter test results, compliance status, and any deviations.
4.6.2 Maintain accurate records of all foreign particulate matter testing activities, including protocols, data sheets, and reports.

5) Abbreviations, if any

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

6) Documents, if any

– Foreign Particulate Matter Testing Protocols and Procedures
– Microscopic Examination Reports
– Test Reports and Data Sheets

7) Reference, if any

– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on foreign particulate matter testing requirements
– Company-specific quality control guidelines

8) SOP Version

Version 1.0