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World Health Organization
WHO Technical Report Series, No. 863, 1996Annex 5
Guidelines for stability testing of
pharmaceutical products
containing well established drug substances in conventional
dosage
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How to fill out guidelines for stability testing
How to fill out guidelines for stability testing
01
Step 1: Understand the requirements and guidelines provided by regulatory authorities.
02
Step 2: Determine the stability testing protocol and testing conditions.
03
Step 3: Select appropriate samples for stability testing.
04
Step 4: Prepare the stability testing samples according to the protocol.
05
Step 5: Conduct the stability tests under specified conditions and time points.
06
Step 6: Evaluate the stability data obtained from the testing.
07
Step 7: Analyze the data and determine the shelf-life and storage conditions of the product.
08
Step 8: Prepare a comprehensive report documenting all the stability testing procedures and results.
Who needs guidelines for stability testing?
01
Pharmaceutical companies
02
Biotechnology companies
03
Medical device manufacturers
04
Cosmetics manufacturers
05
Food and beverage manufacturers
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