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To Improve Product Quality, Train Auditors Well

ISPE
Article - ISPE Pharmaceutical Engineering

How do you build the quality that is essential to all processes and products? Training auditors to conduct good audits is one way. These are some critical skills auditors must know to conduct successful audits:

  • Using audit trails and checklists to prepare and conduct audits
  • Knowing what points are often missed during an inspection
  • Effectively evaluating audit and report findings
  • Identifying critical components for a good audit report
  • Understanding the concepts behind compliance auditing while knowing global cGMP concepts and regulatory requirements related to auditing

Tools such as checklists also can help the auditor focus on key items. With proper training, auditors can find issues early, when they may be more easily corrected—and long before they become unmanageable or systemic. ISPE has a popular course to provide this training, called GMP Auditing for the Pharmaceutical Industry

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