SOP for Conducting Stability Studies for Biological Extracts

Guidelines for Stability Testing of Biological Extracts

1) Purpose

The purpose of this SOP is to provide standardized procedures for conducting stability studies on biological extracts. Biological extracts, including enzymes, hormones, and proteins, may have unique stability challenges due to their complex structure and susceptibility to environmental factors. Stability studies aim to determine the shelf life and appropriate storage conditions to maintain their efficacy and safety.

2) Scope

This SOP applies to all biological extracts produced, handled, or stored by the organization, including but not limited to enzymes, peptides, proteins, and nucleic acids. It is intended for

use by personnel involved in formulation, quality control, and regulatory affairs.

3) Responsibilities

Formulation Scientist: Responsible for designing the study and selecting appropriate stability-indicating parameters.

Quality Control (QC) Team: Responsible for performing stability tests and recording results.

QA Team: Responsible for reviewing study data, ensuring compliance with regulatory

guidelines, and approving the final report.

4) Procedure

4.1 Study Design:

Identify key stability-indicating parameters (e.g., potency, purity, pH, color, and viscosity) for the biological extract.
Select appropriate analytical methods (e.g., High-Performance Liquid Chromatography, Mass Spectrometry) to evaluate these parameters.
Define the storage conditions to be tested, such as refrigerated, frozen, or room temperature.
Prepare a detailed study protocol outlining the objectives, sampling schedule, and analytical methods to be used.

4.2 Sample Preparation:

Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
Store samples in designated stability chambers according to the defined conditions.

4.3 Testing Schedule:

Conduct initial testing on all samples to establish baseline data for the selected parameters.
Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes in stability over time.
Document all test results and analyze data for trends or deviations from acceptance criteria.

4.4 Data Analysis and Reporting:

Analyze data using appropriate statistical methods to determine trends and compliance with acceptance criteria.
Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
Submit the report for QA review and archiving.

5) Abbreviations, if any

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

Biological Extract Stability Protocol: Document detailing the study plan.

Analytical Method Validation Report: Report validating the methods used in the study.

7) Reference, if any

ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

8) SOP Version

Version 1.0