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Objectives of Stability Data Package Guidelines

Updated: Feb 19


The primary aim of these guidelines is to delineate the essential stability data package necessary for the registration of Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs).  This set of guidelines replaces the previous WHO guidelines in this domain. While the outlined recommendations serve as a standard, alternative approaches are admissible when scientifically justified.

The primary aim of these guidelines is to delineate the essential stability data package necessary for the registration of Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs).

This set of guidelines replaces the previous WHO guidelines in this domain. While the outlined recommendations serve as a standard, alternative approaches are admissible when scientifically justified.


Additional guidance is available in the guidelines published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and WHO guidelines related to multisource (generic) finished pharmaceutical products and active pharmaceutical ingredient master file procedure.


Scope of the Guidelines


These guidelines are applicable to both new and existing APIs, addressing the information required for original and subsequent applications seeking marketing authorization for their related FPPs for human use. The guidelines may generally apply to stability testing for biologicals, with additional requirements specific to such products found in the ICH

guideline Q5C.


General Principles


The fundamental purpose of stability testing is to provide evidence of how the quality of an API or FPP changes over time under the influence of environmental factors like temperature, humidity, and light. The stability testing program also encompasses the study of product-related factors, such as interactions with excipients, container-closure systems, and packaging materials. In the case of fixed-dose combination FPPs, the interaction between multiple APIs must be considered.


As a result of stability testing, a retest period for the API or a shelf life for the FPP can be established, and storage conditions can be recommended. The guidelines emphasize that an API is considered unstable when a significant change is observed under the studied conditions.


Storage Conditions and Testing Frequency


The guidelines outline specific storage conditions, including long-term, intermediate, and accelerated conditions, based on climatic data. The frequency of testing is detailed, emphasizing the importance of establishing the stability profile of the API, especially for those with a proposed retest period or shelf life of at least 12 months.


Stress Testing


The guidelines recommend stress testing of the API to identify likely degradation products and establish degradation pathways. Stress testing conditions include variations in temperature, humidity, oxidation, and photolysis. The objective is to identify primary degradation products without completely degrading the API.


Evaluation and Stability Commitments


Evaluation of stability data involves statistical analysis and considerations of batch-to-batch variability. Stability commitments are crucial, and the guidelines provide scenarios where these commitments are necessary, emphasizing the importance of ongoing stability studies.

In conclusion, these guidelines provide a comprehensive framework for stability testing of pharmaceuticals, ensuring the quality, safety, and efficacy of APIs and FPPs throughout their intended shelf life.


They offer a standardized approach while allowing flexibility based on scientific justifications and align with international standards set by organizations like ICH.


Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.

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