1. Introduction
1.1 Objectives of these guidelines
The aim of these guidelines is to outline the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous WHO guidelines in this area (1). However, alternative approaches can be used when they are scientifically justified. Further guidance can be found in guidelines published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (2), in the WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part (3), WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part (4) and WHO guidelines on the active pharmaceutical ingredient master file procedure (5).
It is recommended that these guidelines should also be applied to products that are already being marketed, for example, upon re-registration or upon re-evaluation.
1.2 Scope of these guidelines
These guidelines apply to new and existing APIs and address information to be submitted in original and subsequent applications for marketing authorization of their related FPP for human use. These guidelines may generally apply to stability testing for biologicals; however, there are additional requirements specific to such products and further guidance can be found in ICH guideline Q5C (2).
1.3 General principles
The purpose of stability testing is to provide evidence of how the quality of an API or FPP varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. The stability testing programme also includes the study of product-related factors that influence its quality, for example, interaction of the API with excipients, container-closure systems and packaging materials. In fixed-dose combination FPPs (fixed-dose combinations (FDCs)) the interaction between two or more APIs also has to be considered.
As a result of stability testing, a retest period for the API (in exceptional cases, for example, for unstable APIs, a shelf life is given) or a shelf life for the FPP can be established and storage conditions can be recommended. An API can be considered unstable (under the conditions studied, in a particular type of packaging, etc.) when a significant change is observed. Annex 10 313 Various analyses have been done to identify suitable testing conditions for WHO Member States based on climatic data, to enable each Member State to decide on long-term (real-time) stability testing conditions. Those Member States that have notified WHO of the long-term stability testing conditions they require when requesting a marketing authorization are listed in “Long-term stability testing conditions as identified by WHO Member States”.
Source: ICH, Pls check the follow
Q1F_Stability_Guideline_WHO_2018.pdf
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