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Stability Testing for
Drug Substances and
Drug Products
Speakers:
Dr Thomas First
SANOFI, Germany Dr Wolfgang Grimm
Germany Dr Hired Horn Pharmaceutical Consulting,
Germany
Dr Cornelia
NopitschMai
Bonn,
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How to fill out stability testing for

How to fill out stability testing for
01
Identify the product that requires stability testing.
02
Determine the storage conditions for the product.
03
Set up the necessary testing equipment and facilities.
04
Follow the testing protocol and record all relevant data.
05
Monitor the product over time to assess stability and make any necessary adjustments.
Who needs stability testing for?
01
Pharmaceutical companies
02
Cosmetic manufacturers
03
Food and beverage producers
04
Chemical manufacturers
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What is stability testing for?
Stability testing is conducted to determine the shelf life of a product and ensure its quality and effectiveness over time.
Who is required to file stability testing for?
Manufacturers and distributors of products, especially in industries such as pharmaceuticals, food, and cosmetics, are required to conduct and file stability testing.
How to fill out stability testing for?
Stability testing is typically filled out by documenting the conditions under which the product is stored and testing its characteristics over a period of time.
What is the purpose of stability testing for?
The purpose of stability testing is to ensure that a product remains safe, effective, and of high quality throughout its intended shelf life.
What information must be reported on stability testing for?
Information such as storage conditions, testing methods, results, and conclusions must be reported on stability testing.
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