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Sop 4

This standard operating procedure outlines the process for conducting stability studies to evaluate how pharmaceutical products degrade over time under different storage conditions. It describes determining storage conditions based on regulations and specifications, preparing and labeling samples, storing them appropriately, monitoring them according to a protocol, analyzing results to assess shelf life, reporting findings, and archiving documentation in compliance with regulations. Quality control analysts conduct the studies, while quality assurance oversees adherence to this procedure and regulations.

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51 views2 pages

Sop 4

This standard operating procedure outlines the process for conducting stability studies to evaluate how pharmaceutical products degrade over time under different storage conditions. It describes determining storage conditions based on regulations and specifications, preparing and labeling samples, storing them appropriately, monitoring them according to a protocol, analyzing results to assess shelf life, reporting findings, and archiving documentation in compliance with regulations. Quality control analysts conduct the studies, while quality assurance oversees adherence to this procedure and regulations.

Uploaded by

Dolly Bijani
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Standard Operating Procedure (SOP) for Stability Studies

Objective:

The objective of this SOP is to outline the procedures for conducting stability studies to evaluate the
stability of pharmaceutical products under various storage conditions.

Scope:

This SOP applies to personnel involved in the design, execution, and analysis of stability studies within
the microbiology department.

Responsibilities:

Quality Control Analyst: Responsible for conducting stability studies according to this SOP.

Quality Assurance: Responsible for overseeing compliance with this SOP and ensuring adherence to
regulatory requirements.

Procedure:

Determine the storage conditions to be evaluated based on regulatory requirements and product
specifications.

Prepare the necessary stability samples, ensuring they are representative of the commercial product.

Label each stability sample with unique identifiers, including the product name, batch/lot number, and
storage condition.

Place the stability samples in appropriate storage chambers or conditions (e.g., temperature-controlled
chambers, ambient conditions, accelerated conditions) as per the study design.

Establish a stability study protocol outlining the sampling schedule, testing parameters, and acceptance
criteria.

Monitor the stability samples at predetermined time points according to the study protocol.

Perform stability-indicating tests (e.g., assay, impurity analysis, microbial testing) on the stability
samples as per product specifications.
Record all observations, test results, and any deviations from expected stability trends.

Analyze the stability data to assess product degradation kinetics and determine shelf-life projections.

Prepare stability reports summarizing the study findings, including any recommendations for product
labeling or storage conditions.

Archive stability samples and study documentation as per regulatory requirements.

Notify Quality Assurance of any deviations from the study protocol or unexpected results.

Documentation:

Stability study protocol

Stability study reports

Data logs and test results

Deviation reports (if applicable)

Training:

All personnel involved in conducting stability studies must receive training on this SOP and relevant
analytical techniques.

References:

International Council for Harmonisation (ICH) guidelines for stability testing

Regulatory requirements for stability testing in relevant jurisdictions

Revision History:

Any revisions to this SOP must be documented, and all affected personnel must be notified of the
changes.

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