Standard Operating Procedure for Assay Testing

1) Purpose

This SOP outlines the procedures for conducting assay testing on pharmaceutical raw materials and products.

2) Scope

This SOP applies to assay 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 assay 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 assay testing protocol and ensure all necessary materials and equipment are available (e.g., analytical balance, reference standards).
2. Verify the calibration and functionality of the analytical 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. Weigh the sample accurately using an analytical balance.
2. Prepare the sample solution or dispersion according to the assay method.
3. Analyze the sample using the appropriate analytical technique (e.g., chromatography, titration).
4. Calculate the assay result based on the method formula and using reference standards.
5. Perform assay testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the assay results of the tested samples meet 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 assay 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

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

7) Reference, if any

Regulatory guidelines such as USP <1225> Validation of Compendial Methods, European Pharmacopoeia (Ph. Eur.) 2.2.40 Assay

8) SOP Version

Version 1.0