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To provide written instructions for meeting the regulatory requirements for employees involved in current Good Manufacturing Practices of dietary supplements.Note, this SOP is only required for those manufacturing supplement product
Any employees involved in dietary supplement manufacturing are responsible for following this SOPHuman Resources employees are responsible for following this SOP. Quality Control personnel are responsible for following this SOP.
The company will ensure that employees involved in current Good Manufacturing Practices (cGMPs) will meet the regulatory requirements as laid out in All employees involved in cGMPs will be qualified for such positions. Each employee involved in cGMPs will have the education, training, or experience to perform the person’s assigned functions. All supervisors of cGMP operations will have the education, training, or experience to perform the person’s assigned functions.Each employee who is responsible for Quality Control operations (QC personnel) will be identified and will be qualified to do so, and will have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing QC operation. Each employee who is responsible for QC operations will have the education, training, or experience to perform the person’s assigned functions. When practical, the person performing a given QC operation will be a different person than the person who performed the operation subject to QC oversight (FDA recommendation, but not requirement – ). All training relating to cGMPs will be documented, and include the date(s) of training, the type(s) of training, and the person(s) trained. All training documentation will be maintained by Quality and Regulatory Affairs.
PURPOSE
RESPONSIBILITY
DEFINITIONS
Quality Control Personnel
Any person, persons, or group, within or outside of your organization, who are designated to be responsible for quality control operations.
PROCEDURES
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