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CGMP Good Manufacturing Practice

CGMP Good Manufacturing Practice

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

To follow CGMP includes establishing strong quality management systems, using good quality raw materials, implementing robust operating procedures, meticulously screening and investigating product quality deviations, and maintaining reliable testing laboratories.

Put simply, to follow CGMP a company must have:

  • Facilities that are kept in good condition;
  • Equipment that is carefully maintained and calibrated;
  • Employees who are qualified and fully trained and;
  • Operating procedures that are reliable and reproducible.

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