February 16, 2012
SILVER SPRING, Md.The American Herbal Products Association (AHPA) is offering more than 30 standard operating procedure (SOP) templates to help companies meet dietary supplement current good manufacturing practice (cGMP) compliance. The SOP variance templates were developed for an AHPA educational seminar, "cGMP Compliance Series Teleseminar: Variances," by Staci Eisner, vice president of quality for Cortex Scientific Botanicals and chair of the AHPA Government Relations Committee.
The templates focus on variances, which are exception or departures from approved protocol. Under FDA regulations for cGMPs, variances must be detected, investigated, documented, explained, and addressed. AHPA's SOP templates will offer newer companies a jump-start with cGMP and established businesses with a means to examine their current SOPs. The templates include fully customizable examples of SOP reports and log forms, including: Unplanned Events; Calibration Failures; Nonconforming Materials; Planned Deviations; Production Failure; Corrective & Preventative Actions; Out of Specification Investigations; Customer Complaints; Returned Goods; Reportable Foods; and Recall Procedure.
To purchase the SOPs templates and the seminar for which they were developed, visit theAHPA online bookstore. AHPA members receive a substantial discount.
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