Standard Operating Procedure for Particulate Matter Testing

1) Purpose

This SOP outlines the procedures for testing particulate matter in pharmaceutical products to ensure compliance with quality standards and regulatory requirements.

2) Scope

This SOP applies to the testing of particulate matter in injectable and other pharmaceutical products, including vials, ampoules, and prefilled syringes.

3) Responsibilities

The Quality Control (QC) department is responsible for performing particulate matter testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the particulate matter testing protocol and ensure all necessary materials and equipment are available (e.g., particle counter, sample preparation tools).
2. Verify the cleanliness and calibration of testing equipment.

4.2 Sample Collection and Preparation

1. Collect representative samples of the pharmaceutical product according to sampling procedures.
2. Prepare samples for testing by following established procedures (e.g., dilution, filtration).

4.3 Testing Procedure

1. Perform particulate matter testing using a validated particle counting method.
2. Run the test for each sample as per defined parameters (e.g., sample volume, flow rate).
3. Record the test results, including particle count and size distribution.

4.4 Acceptance Criteria

1. Compare the test results against the acceptance criteria specified in compendial standards or product specifications.
2. Ensure that the tested samples comply with limits for particulate matter.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a particulate matter testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

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

6) Documents, if any

Particulate Matter Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <788> Particulate Matter in Injections, USP <789> Particulate Matter in Ophthalmic Solutions, European Pharmacopoeia (Ph. Eur.) 2.9.19 Particulate Contamination: Visible Particles, Ph. Eur. 2.9.20 Particulate Contamination: Sub-Visible Particles

8) SOP Version

Version 1.0