Social networks in drinking behaviors among Japanese: support network, drinking network, and intervening network

Yoshihara, C.; Shimizu, S.

Nihon Arukoru Yakubutsu Igakkai Zasshi 40(5): 441-454

2005


ISSN/ISBN: 1341-8963
PMID: 16316069
Document Number: 9534
Significant advancement in the design and implementation of effective validation programs has been made since the 1987 Food and Drug Administration (FDA) Guideline on General Principles of Process Validation. (1) Open, candid discussions at conferences, many of which were dedicated specifically to process validation, and at other open forums have resulted in common practices. The guidelines presented here are intended to assist in the design and execution of process validation studies to ensure the reproducibility and robustness of the process. Points to consider are provided to facilitate collection of data to support a regulatory filing for the approval of a drug substance intended to be used in a pharmaceutical product. The information provided in these guidelines is one technical approach to process validation activities and documentation based on the experiences and practices of a PDA Task Force that represents a cross-section of industry professionals. The presented guidelines represent what the authors believe to be best practices that are science-based and value-added and are believed to make good business sense as well as meet current regulatory expectations. The document does not contain isolated responses to individual inspections or reviews. Such responses are often driven by case-by-case requirements particular to specific organizational needs

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Social networks in drinking behaviors among Japanese: support network, drinking network, and intervening network