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Review
. 2024 Jul 7;17(7):903.
doi: 10.3390/ph17070903.

Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients

Naseem A Charoo  1 , Omotayo Akanji  2 , Ziyaur Rahman  3 , Aqeel A Khan  4 , Aqal Badshah  4
Affiliations
Review

Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients

Naseem A Charoo et al. Pharmaceuticals (Basel). .

Abstract

Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products. The ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and WHO (World Health Organization) regulatory guidelines mandate that after the retest period, the drug substances must be retested for compliance with the specification and then used immediately in the manufacture of the finished product. Although these substances can be retested multiple times, an emphasis is placed on immediate use following a retest and compliance with standards. The phrase "used immediately" is ambiguous and is left for interpretation. In this article, we will look at the various processes that must be completed to determine the retest date. In addition, we present a risk-based method for establishing retest dates and the time during which material can be used.

Keywords: critical material attributes; critical quality attributes; retest; risk assessment; shelf life.

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Conflict of interest statement

Authors Aqeel A. Khan and Aqal Badshah were employed by the company Adcan Pharma LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Proposed steps in establishing a retest date: (A) active pharmaceutical ingredients; (B) excipients.
Figure 2
Figure 2
Main degradation mechanisms of some drug substances.
See this image and copyright information in PMC

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References

    1. ICH Harmonised Tripartite Guideline. Stability Testing of New Drug Substances and Products, Q1A(R2) 2003. [(accessed on 2 May 2024)]. Available online: https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf.
    1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-Second Report. [(accessed on 2 May 2024)]. Available online: https://iris.who.int/bitstream/handle/10665/272452/9789241210195-eng.pdf....
    1. ICH Harmonised Tripartite Guideline. Evaluation for Stability Data, Q1E. 2003. [(accessed on 2 May 2024)]. Available online: https://database.ich.org/sites/default/files/Q1E_Guideline.pdf.
    1. Deng T., Garg V., Bradley M.S.A. Electrostatic charging of fine powders and assessment of charge polarity using an inductive charge sensor. Nanomanufacturing. 2023;3:281–292. doi: 10.3390/nanomanufacturing3030018. - DOI
    1. Peart J. Powder electrostatics: Theory, techniques and applications. KONA Powder Part. J. 2001;19:34–45. doi: 10.14356/kona.2001009. - DOI

Grants and funding

This research received no external funding.

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