Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.
Improving Documentation of GMP Procedures - Natural Products Insider:
"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:
- Document all procedures in manufacturing operations.
- Maintain all records for plant and equipment cleaning processes.
- Mandate techniques for product sampling.
- Ensure approval by QC personnel for all procedures, tests, controls and deviations.
- Implement a control process for product labeling.
- Require QC personnel to provide results of initial or final products.
- Provide a procedure to follow if documented specifications are not met.
- Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."
