CH Guidelines – Stability Studies in Drug Substance

CHEM53202 Assignment: ICH Guidelines – Stability Studies in Drug Substance and Drug ProductsThe International Council for Harmonization (ICH) has been instrumental in providing guidelines to
identify critical data and information required for the registration of drug substances and drug products.
Stability studies are required for monitoring and evaluating the critical quality attributes of active
pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) in response to various
environmental conditions. Stability studies involve long periods of time to conduct. Accelerated
predictive stability (APS) studies have recently emerged as a way to predict long-term stability of APIs
and FPPs to improve on the cost, efficiency and duration of these critical stability studies required for
submissions. For this assignment, you will have the opportunity to reflect on topics discussed during
lectures in relation to stability and provide your recommendation on using APS methods to generate
information required for submission of data for stability studies as per ICH guidelines.
Due Sunday November 26, 2023 before 11:59PM
Read the review by Gonzalez-Gonzalez et al. (2022). Reflect on this article in relation to ICH
requirements for stability information described in module 3 (CTD-Quality M4Q R1) and references
therein. Select either a drug substance or drug product, which can either be a biologic or chemical
entity. Write an essay where you include your answers to the questions below, summarized in a single
document that is a maximum of 1000 words (double-spaced, 12 point font, four page maximum, plus
one page for references):
1) Provide a brief description on the stability challenges typically encountered for either a drug
substance or finished drug product.
2) Describe how the stability studies are typically conducted for either a drug substance or drug
product. Include the types of apparatus, environmental conditions and timepoints for long-term
studies.
3) Briefly describe the type of analytical methods used to assess the quality attributes for either
the drug substance or drug product at various timepoints in long-term stability studies.
4) Describe the rationale and process for conducting accelerated predictive stability studies, and at
least one advantage and one disadvantage of APS in relation to conducting such studies to fulfil
the registration requirements for stability studies as per ICH guidelines
5) Overall, do you support the use of APS studies to fulfil the stability study requirements as per
ICH guidelines for the safe production of batches for clinical trials? Please explain your answer.
***Please ensure you review the rubric for guidance on how this assignment will be evaluated***