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Expiration dating and stability testing for human drug products

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Added: 16.09.2019
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From a pharmaceutical development point of view, stability studies are frequently on the critical path to starting patient studies and registration stability studies, as described in the International Conference on Harmonisation ICH guideline Q1A R2 , are commonly the activity on the critical path to regulatory filing and approval [1]. Stability studies are also a significant resource commitment in both pre and post-approval phases. This article examines the decisions to be made regarding the design of a stability strategy during development and some alternative approaches, compared to those traditionally followed, are proposed as being more scientifically rigorous. Following these approaches would lead to better product understanding and robustness as well as to a reduction in the number of scientifically redundant stability studies. The development of the ICH stability guidelines led to a significant degree of harmonization of expectations and, more recently, the World Health Organization WHO stability guideline has extended the reach of these efforts [2,3].
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Guideline for the Stability Testing of Nonprescription (OTC) Drug

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Guideline for the Stability Testing of Nonprescription (OTC) Drug

Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences. The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by OTC drug products meeting the exemption of
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Stability Testing – Doing Everything or Doing the Right Thing?

Stability studies on a finished pharmaceutical product should be designed in the light of the properties and stability characteristics of the drug substance as well as the climatic conditions of the intended market zone. Before stability studies of dosage forms are initiated, information on the stability of the drug substance should be sought, collected and analysed. Published information on stability is available on many well established drug substances. For registration purposes, test samples of products containing fairly stable active ingredients are taken from two different production batches; in contrast, samples should be taken from three batches of products containing easily degradable active ingredients or substances on which limited stability data are available.
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