STABILITY STUDY (ICH VS WHO)

Summary

This video compares the stability testing guidelines of ICH (International Council for Harmonisation) and WHO (World Health Organization) for drug substances and products. It outlines differences in scope, regional applicability, climatic zones, primary batch requirements, and submission data between ICH and WHO guidelines. Notably, ICH focuses on new drug substances and products, while WHO covers both new and existing substances. Other differences include storage conditions, long-term data requirements, and guidance for excursions in storage. The video highlights the key distinctions between both guidelines, emphasizing their regional and procedural variations.

Takeaways

• 😀 ICH guidelines focus on stability testing for new drug substances (DS) and drug products (DP), while WHO guidelines cover both new and existing drug substances and products.
• 😀 ICH guidelines are applicable to Europe, Japan, and the U.S., whereas WHO guidelines are intended for all WHO member states.
• 😀 ICH guidelines primarily cover Zone 1 and Zone 2 climatic zones, while WHO guidelines cover all four zones (Zone 1, Zone 2, Zone 3, Zone 4).
• 😀 ICH requires 3 primary batches for new drug substances and products, while WHO may accept 2 primary batches for existing, stable products, or 3 for new products or unstable ones.
• 😀 ICH stipulates 6 months of accelerated/intermediate data and 12 months of long-term data for new products, whereas WHO allows 6 months of accelerated/intermediate and long-term data if the product is stable.
• 😀 ICH provides no specific guidance for excursions in storage conditions, while WHO allows excursions of up to 24 hours, with corrective actions or transfers to another chamber.
• 😀 ICH suggests two possible long-term storage conditions for room temperature products: 25°C/60% RH or 30°C/65% RH, whereas WHO permits three options: 25°C/60% RH, 30°C/65% RH, or 30°C/75% RH.
• 😀 ICH defines 25°C/60% RH as the accelerated condition for refrigerated products (5°C), while WHO allows 25°C/60% RH, 30°C/65% RH, or 30°C/75% RH for the accelerated conditions for refrigerated products.
• 😀 The ICH guideline does not offer specific guidance on the duration a stability chamber can be out of order, while WHO provides a limit of 24 hours for corrective actions.
• 😀 The differences between ICH and WHO guidelines are important for determining stability testing protocols depending on the region and type of drug substance or product.

Q & A

What is the main difference between ICH and WHO guidelines for stability testing?

The ICH guideline focuses on new drug substances (DS) and new drug products (DP), while the WHO guideline covers both new and existing drug substances and products.

What is the regional scope of the ICH stability guideline?

The ICH guideline applies to European countries, Japan, and the U.S.

Which climatic zones are considered in the ICH stability guideline?

The ICH guideline predominantly considers Zone 1 and Zone 2 climatic zones.

What climatic zones does the WHO stability guideline apply to?

The WHO guideline covers all four climatic zones: Zone 1, Zone 2, Zone 3, and Zone 4.

How many primary batches are required according to ICH for stability testing of new drug substances and products?

ICH requires three primary batches for stability testing of new drug substances and new drug products.

What is the requirement for primary batches according to WHO?

WHO requires two primary batches if the product is known to be stable, but three batches are necessary if the product is new or needs further stability testing.

What are the minimum data requirements at submission according to ICH?

ICH requires six months of accelerated or intermediate data and 12 months of long-term data for new drug substances and products.

What are the data requirements for existing drug substances and products under WHO guidelines?

WHO requires six months of accelerated or intermediate data and long-term data for existing drug substances and products if they are known to be stable.

How does the ICH guideline address the issue of excursions in storage conditions?

The ICH guideline does not provide specific guidance on excursions in storage conditions.

What does the WHO guideline say about corrective actions if the stability chamber is out of order?

According to WHO, if the stability chamber is out of order, corrective measures should be taken within 24 hours. Alternatively, samples can be transferred to another chamber with similar conditions.

What are the long-term storage conditions for drug substances or products according to ICH?

ICH guidelines suggest storing at either 25°C with 60% relative humidity (RH) or 30°C with 65% RH for long-term conditions.

What long-term storage conditions are specified by WHO for drug substances or products?

WHO allows three options for long-term conditions: 25°C/60% RH, 30°C/65% RH, or 30°C/75% RH.

How do ICH and WHO guidelines differ for accelerated storage conditions for refrigerated products?

For refrigerated products (5°C), ICH suggests using 25°C and 60% RH as the accelerated condition, while WHO allows 25°C/60% RH, 30°C/65% RH, or 30°C/75% RH for the accelerated condition.