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ANNEX H GUIDELINES ON STABILITY STUDY AND SHELFLIFE OF HEALTH SUPPLEMENTSI.The design of a stability study for the product should be based on the nature of the product. It should take into account

How to fill out guideline on stability testing

How to fill out guideline on stability testing

1. Gather all necessary documents related to the product being tested.
2. Define the product's stability testing protocol, including temperature, humidity, and light conditions.
3. Establish the testing duration and intervals for sample analysis.
4. Select appropriate physical, chemical, and microbiological testing methods.
5. Prepare and label samples according to guidelines to avoid mix-ups.
6. Conduct baseline analysis before storage to understand initial product quality.
7. Store samples under defined conditions according to the stability plan.
8. Analyze samples at each designated interval to monitor changes.
9. Document all findings comprehensively and compare them against the acceptance criteria.
10. Review results and prepare a summary report detailing the stability profile.

Who needs guideline on stability testing?

1. Pharmaceutical companies conducting drug development.
2. Cosmetic and personal care product manufacturers.
3. Food and beverage producers ensuring product safety.
4. Contract testing laboratories performing stability analysis.
5. Regulatory agencies overseeing product compliance.

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What is guideline on stability testing?

The guideline on stability testing provides a framework for evaluating the stability of pharmaceutical products throughout their shelf life, ensuring that they maintain their intended quality, safety, and efficacy.

Who is required to file guideline on stability testing?

Manufacturers and sponsors of pharmaceutical products are required to file guidelines on stability testing as part of their regulatory submissions to ensure compliance with safety and quality standards.

How to fill out guideline on stability testing?

To fill out the guideline on stability testing, fill in details such as product description, testing conditions, test methods, stability data, and any observed changes over time following the prescribed format in the guideline.

What is the purpose of guideline on stability testing?

The purpose of the guideline on stability testing is to establish testing protocols that ensure pharmaceutical products remain safe, effective, and of good quality throughout their intended shelf life.

What information must be reported on guideline on stability testing?

Information that must be reported includes product characteristics, testing protocols, stability data, results of physical and chemical tests, and any significant changes observed during the study period.