In June 2007, the FDA issued the Current Good Manufacturing Practice (CGMP) requirements for Dietary Supplements (21 CFR Part 111). In essence, the ruling requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.
Companies that manufacture, package, label, or hold dietary supplements are required to follow the GMP rule.
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As a manufacturer of dietary supplements, you may be looking for integrated solutions for document control or document management, training and CAPA that are reasonably priced and assure compliance with 21 CFR Part 111. MasterControl can provide these solutions, and all of the solutions you need to establish procedures for quality control operations, effectively handle deviations (planned and unplanned), keep written records of customer complaints related to the Current Good Manufacturing Practice (CGMP) requirements, etc.
To ensure that the good manufacturing practices specified by the FDA are met, a company involved in the manufacturing, packaging, labeling, or holding of dietary supplements must address a number of challenges, including:
For more information about the solutions provided by MasterControl for manufacturers of dietary supplements, please feel free to contact a MasterControl representative.