PMcG Consulting
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Auditing


PMcG Consulting provides auditing services to prepare you for regulatory or pre-licensing GMP audits




Facing a regulatory audit can be intimidating, as it often brings considerable stress. Much of this anxiety stems from uncertainty about what to expect. Since an audit only captures a moment within your operations, you cannot anticipate every aspect that might come under scrutiny—no matter how well you prepare.


PMcG Consulting provides auditing services to prepare you for regulatory or pre-licensing GMP audits. We can also audit your internal QMS, function as your QA to conduct supplier audits, and perform self-inspections. After audits, we assist with responses and implementing solutions to any observations.

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Modern laboratory with glass bottles containing amber liquid on a reflective metal table.

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Key tips for audit success:


  • Maintain clear, traceable documentation
  • Ensure SOPs are current and compliant
  • Record and investigate quality incidents; assign corrective and preventive actions
  • Implement and monitor these actions for effectiveness
  • Validate critical processes and procedures
  • Qualify equipment
  • Train staff well
  • Document and justify risk assessments

Regular self-inspection and trending of quality incidents support ongoing compliance and help identify opportunities for improvement.


For details or to discuss our services, please contact us.

 

 "Pauline is keen and hardworking, she loves her sciences and passionate about what she does. I so much enjoyed working with her, she has provided great insight on many technical and scientific issues related to analytical method development and analytical method validation. Her most important quality is her patience and perseverance and of course, fun to work with."

 

 Arwa Shahin

Quality and Compliance Director



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Phone

1-905-257-6738

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Email

pauline@pmcgconsulting.com


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