Thursday, May 22, 2014

Improving Documentation of GMP Procedures - Natural Products Insider

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."
'via Blog this'

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