Self Inspection for GMP Compliance and Continuous Improvement

March 09, 2017
by SeerPharma

Self inspection, commonly referred to as an internal audit, is a fundamental part of implementing, maintaining and improving your Pharmaceutical Quality System.  Written into the PIC/S Guide to GMP as chapter 9 due to its criticality, Pharmaceutical manufacturers must ensure their self inspection programme is effective.

Self inspections deliver value to all GMP companys' quality systems - irresepective of maturity - and if the programme is deployed throughout the organisation, it can serve to educate personnel, confirm ownership of various quality system elements, optimise business processes and ultimately drive continuous improvement and reduced costs.

Self Inspection

Would you like to gain more value from your internal audit programme?

SeerPharma supports many of its clients in this space with both training and consulting. Some examples of how we can help your organisation include:

  • Understand the framework around regulations, guidance and best-practices such as:
    • PIC/S Guide to GMP and EU GMP Guide
      • Part I, Chapter 1 Pharmaceutical Quality System and Chapter 9 Self Inspection
      • Part II, Quality Management, Internal Audits for Active Pharmaceutical Ingredients (APIs)
    • ICH Q9 Quality Risk Management
    • ICH Q10 Pharmaceutical Quality System
  • Apply Quality Risk Management principles to youraudit scheduling and audit practices
  • Implement the six fundamental steps of auditing to manage & facilitate constructive self inspections
  • Understand and apply the CAPA system

Contact us to discuss your internal audit programme and how SeerPharma could help you optimise it to deliver more value.

Click here to learn about our public or on-site training program, "Internal Audits - A Key to Your Quality System".

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Filed Under: GMP, Continuous Improvement, Internal Audit, Self Inspection