Stability challenges not addressed by harmonized guidance \u2013 AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD

Anthony Mazzeo,Kim Huynh-Ba,Bowen Jiang,Mohd M Khan

doi:10.1186/s41120-018-0022-4

Abstract

An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration (FDA) presented and facilitated the round-table discussions. A total of fifty-five participants that included experienced pharmaceutical scientists, both from small and large pharmaceutical companies and service providers, benefited from the opportunity to interact face-to-face with industry partners and regulatory agency SMEs.The two-day meeting was divided into five major sections to ensure face-to-face interactions and round-table discussions between participants and SMEs: 1) statistical approaches to stability, dissolution, and shelf life testing, 2) microbiological quality of drug products, 3) strategies to support distribution, unplanned excursions, and transportation of drug products, 4) regulatory considerations on stability testing of biologics, and 5) in-use stability during clinical and commercial phases. All in all, this interactive workshop focused on challenges and successes of addressing stability concerns that affect pharmaceutical development, manufacturing, distribution, and use of drug substances/products for which no or limited ICH guidance exists. The interactive meeting provided a unique opportunity to industrial scientists and regulatory agency liaisons to facilitate the discourse on how to address stability challenges that are not addressed in harmonized guidelines: this paper summarizes those discussions.

Highlights

An American Association of Pharmaceutical Scientists (AAPS) workshop on “Stability Challenges not Addressed by Harmonized Guidance” was held on April 3rd – 4th, 2017 at Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center, Rockville, MD
During drug development and commercial distribution of drug products, there are a number of regulatory expectations on their stability for which there is limited guidance from the International Conference on Harmonization (ICH)
Examples where the guidance is limited include a) the impact of temperature excursions during distribution, b) in-use stability once a product is opened from multiuse packaging or when constituted after distribution, c) photostability requirements for light-sensitive products, especially during in-use conditions, d) holding and storage of bulk drug substance and drug product, e) freeze/thaw cycle impact on biologics, Khan et al AAPS Open (2018) 4:2 semi-solids, and liquids, f ) stability requirements for biologics, and g) microbiological quality assessment of drug products in a post-penetrated container system

Summary

Introduction

An AAPS workshop on “Stability Challenges not Addressed by Harmonized Guidance” was held on April 3rd – 4th, 2017 at Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center, Rockville, MD. During drug development and commercial distribution of drug products, there are a number of regulatory expectations on their stability for which there is limited guidance from the International Conference on Harmonization (ICH).

Results

Conclusion