Audit Checklist for Drug Industry

Audit Checklist for the Drug IndustryAudit Checklist


Prepared by:

[YOUR NAME]

Date:

January 5, 2055

Company Name:

[YOUR COMPANY NAME]


A. Regulatory Compliance

  • Verification of timely approval and renewal of manufacturing licenses.

  • A thorough examination of GMP (Good Manufacturing Practices) adherence.

  • Inspection of meticulous documentation and record-keeping practices.

  • Assessment of strict compliance with drug labeling regulations.

  • Scrutiny of ethical marketing practices to ensure transparency.

  • Monitoring of proper handling, storage, and transportation procedures.

  • Evaluation of effectiveness and efficiency of product recall procedures.


B. Quality Control

  • Review of comprehensive laboratory testing procedures.

  • Examination of raw material quality and adherence to standards.

  • Inspection of equipment calibration and validation processes.

  • Ongoing monitoring of the entire production process.

  • Compliance check with established quality control protocols.

  • Assessment of product stability and potency over time.

  • Review of product packaging integrity and security.


C. Safety Measures

  • Inspection of safety equipment and enforcement of protective clothing usage.

  • Compliance check with toxic waste disposal protocols.

  • Evaluation of the effectiveness of emergency and evacuation procedures.

  • Assessment of employee safety training programs.

  • Ongoing monitoring of environmental, health, and safety policies.


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