AAPS Workshop Summary - Pharmaceutical Technology

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AAPS Workshop Summary
A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC. This article summarizes some of the topics presented at the AAPS workshop on various scientific aspects affecting pharmaceutical stability. A full summary can be read online at www.PharmTech.com/AAPSstability. A follow-up AAPS workshop on pharmaceutical stability is being planned for 2013.

Pharmaceutical Technology
Volume 36, Issue 11, pp. 66-68

Stability testing to support distribution of temperature-sensitive pharmaceuticals
Robert H. Seevers

This presentation discussed the other types of testing which may be conducted in addition to the standard ICH conditions that permit a stability budget to be created for a pharmaceutical. Besides using data from long-term and accelerated testing such as that provided for in the ICH guidances, the speaker proposed adding freeze-thaw and temperature cycling studies to create a fuller picture of a drug's susceptibility to temperature changes during the entire distribution process from manufacture to transport, storage, and end use. It was shown that the concept of time out of refrigeration, which allows for room temperature operations such as packaging and labeling of refrigerated products, can be expanded to the entire distribution process.

Effective approaches for conducting method transfer
Kim Huynh-Ba

Method transfer is a process of which an analytical laboratory is qualified to perform a testing procedure as part of method validation. The speaker discussed the options of transfering analytical procedures from one laboratory to another and effective approaches to be considered when conducting method transfer. Transfer activities are conducted according to a protocol with predetermined acceptance criteria agreed upon by all sites involved. This includes certain SOPs such as data review, data reporting, and out-of -specification (OOS) / out-of-trend (OOT) investigation from both sites. Conclusion of the transfer must be documented with all data reported. It is important that validation data are available to the receiving lab as part of the transferring background package and the receiving lab must conduct a thorough gap analysis before any testing can be done.

Interesting and challenging stability-related regulatory questions: a roundtable discussion
Panelists: Stephen Colgan, Robert J. Timpano, Ganapathy Mohan, and David Lin

The roundtable discussion was focused on regulatory queries, with science and risk-based approaches to stability/shelf-life and stability protocols being of particular interest. Firstly, it was noted that FDA does not provide guidance on biorelevance in stability protocols; the audience was, however, encouraged to use science to support stability testing protocols. Secondly, whilst scientific engagement with the regulators in the ICH regions would be welcomed, this is not the case for most of the emerging market regions. There was also a discussion that science-based stability protocols should only focus on the relevant product attributes because this approach would be leaner, and would protect the patient as well as non-lean protocols. The panel noted that the quality target product profile (QTPP) could be leveraged to advocated lean stability protocols.

The most enthusiastic discussion was on a liquid product in a semi-permeable or non-permeable container and the suitability of a matrixed stability protocol for containers stored upright, upside down, and lying down. Developing a matrixed protocol can be difficult and the panel recommended reviewing the protocol with the regulatory authorities before execution. From a scientific point of view, the panel noted that a stability risk assessment would help define attributes that should be monitored for stability, including effects of container orientation, and determine whether a matrixed approach was required. It was agreed that science and knowledge of the regulations should be key drivers when developing stability protocols.

Lead author: Dilip R. Choudhury, PhD,* is with Allergan and can be reached at
, tel: 714.246.2288. Additional contributors: Ramesh K. Sood, PhD, is with FDA; John Bobiak, PhD, is with Bristol-Myers Squibb; Mark Alasandro, PhD, is with Allergan, Inc., Steven W. Baertschi, PhD, is with Elli Lilly and Company; Bekki Komas, is with Glaxo Smith Kline; M. J. Skibic, PhD, is with Elli Lilly and Company; Brian W. Pack, PhD, is with Elli Lilly and Company; Saji Thomas, is with Par Pharmaceuticals; Robert H. Seevers, PhD, is with Eli Lilly and Company; Kim Huynh-Ba, is with Pharmalytik; and Stephen Colgan, PhD, is with Pfizer.

*To whom all correspondence should be addressed.


1. S.W. Baertschi, K.M. Alsante and H.H. Tonesen, J. Pharm. Sci. 99 (7) 2934–2940 (2010).

2. M.J. Skibic et al. J. Pharm. Biomed. Analysis. 53 (3) 432–439 (2010).


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