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GMP Certification Programme Certified Quality Control ManagerSpeakersDr Ulli Backofen Boehringer Ingelheim, GermanyStability Testing for Drug Substances and Drug Products 23/24 October 2024 | Barcelona,

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How to fill out stability studies to support

01

Identify the product description including strength, dosage form, and packaging.

02

Determine the proposed storage conditions for the product.

03

Select appropriate time points for testing stability.

04

Conduct testing under controlled environmental conditions.

05

Analyze and interpret the stability data.

06

Prepare a stability report summarizing the findings.

Who needs stability studies to support?

01

Pharmaceutical companies seeking regulatory approval for new drug products.

02

Manufacturers of dietary supplements and food products.

03

Biotechnology companies developing biologics or biosimilars.

04

Cosmetics companies looking to ensure product quality and safety.

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What is stability studies to support?

Stability studies support the determination of how the quality of a product varies over time under the influence of a variety of environmental factors.

Who is required to file stability studies to support?

Manufacturers and producers of pharmaceuticals and other products are required to file stability studies to support.

How to fill out stability studies to support?

Stability studies are typically filled out by conducting tests on the product under specified conditions and documenting the results.

What is the purpose of stability studies to support?

The purpose of stability studies is to ensure that products remain safe and effective throughout their shelf life.

What information must be reported on stability studies to support?

Stability studies must report on factors such as temperature, humidity, light exposure, and testing methods.

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