Container closure development for drug products has undergone significant evolution within the last 10 years. However, the information available to guide manufacturers in the design and testing of container closures is relatively limited. The FDA Guidance for Industry on Container Closure Systems for Packaging of Human Drugs and Biologicals is more than 12 years old. Other, more recent, guidance documents written by the International Conference on Harmonization provide added insight regarding the evaluation of container closures. Further, a modest number of pharmacopoeial requirements and regional regulations have been written that relate to container closures for pharmaceutical products. However, it is not clear whether this collection of documents is sufficient to capture current industry best practices, and whether scientists responsible for container closure development are satisfied with the level of guidance provided by these regulatory documents.
In this study, a literature review was combined with a survey of current practices and views of scientists responsible for developing and testing container closures. The literature showed that current industry practices extend beyond the current requirements of the regulatory paradigm. It further suggested that testing of extractables and leachables is regarded as an area in which more guidance may be needed. The survey that focused on extractables and leachables testing further identified substantial variation in the practices of industry scientists. The majority of scientists identified that the FDA Guidance document written in 1999 has the greatest impact on their testing programs but that this document is inadequate and in need of revision. Survey results further suggested that many of the other available documents are not sufficiently broad to meet the needs of many scientists. Taken together, the data lead to a recommendation that the FDA guidance document of 1999 be prioritized for revision in the near future.
|Advisor:||Alkana, Ronald L., Richmond, Frances J.|
|Commitee:||Alkana, Ronald L., Clemens, Roger, Fleitman, Jeffrey, Loeb, Gerald, Richmond, Frances J.|
|School:||University of Southern California|
|School Location:||United States -- California|
|Source:||DAI-B 73/11(E), Dissertation Abstracts International|
|Subjects:||Packaging, Pharmacy sciences|
|Keywords:||Container closure, Extractables, Leachables, Pharmaceutical containers|
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