AOA's position against use of placebos for pain management in end-of-life care
Nichols, K.J.; Galluzzi, K.E.; Bates, B.; Husted, B.A.; Leleszi, J.P.; Simon, K.; Lavery, D.; Cass, C.
Journal of the American Osteopathic Association 105(3 Suppl 1: S2-S5
2005
ISSN/ISBN: 1079-7440 PMID: 18154190 Document Number: 12982
Pharmaceutical companies and glass manufacturers have made quality decisions based on visual inspections of glass containers without the aid of universal guidelines or standards. Inconsistency in defining glass container nonconformities has resulted in a lack of clarity within the pharmaceutical industry and a nonuniform approach in meeting regulatory expectations to deliver high quality pharmaceutical products. In light of the aforementioned, PDA members recognized the need to provide guidelines for the identification and classification of glass container nonconformities in the form of a consensus-based technical report. Subsequently, a task force was formed representing a broad cross-section of glass and pharmaceutical manufacturer professionals to create a consensus document. These guidelines provide an approach to a quality decision-making process; it is up to each organization to develop a process that best suits its needs. The following guidelines represent what the authors believe to be best practices for identification and classification of visual nonconformities for glass containers.
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