Standard Operating Procedure for Identification Tests

1) Purpose

This SOP outlines the procedures for conducting identification tests on pharmaceutical raw materials and products.

2) Scope

This SOP applies to identification testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing identification tests. 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 identification testing protocol and ensure all necessary materials and equipment are available (e.g., infrared spectrometer, reference standards).
2. Verify the calibration and functionality of the identification equipment.

4.2 Sample Collection and Preparation

1. Collect representative samples of raw materials or products according to sampling procedures.
2. Prepare the samples by ensuring they are properly labeled and identified.
3. If necessary, prepare the samples by grinding or any other specified method.

4.3 Testing Procedure

1. Prepare the identification instrument according to manufacturer instructions and method protocol.
2. Insert the sample into the instrument and record the spectrum or chromatogram.
3. Compare the obtained spectrum or chromatogram with reference standards or databases to confirm the identity of the sample.
4. Perform identification testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the identification results of the tested samples match the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare an identification 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

Identification Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <191> Identification Tests, European Pharmacopoeia (Ph. Eur.) 2.2.24 Identification

8) SOP Version

Version 1.0