GMP VENDOR AUDIT (VA).

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Supplier GMP Vendor Audit.

The GMP Vendor Audit (VA) requirement sprung to life in the aircraft industry, in the late 1950’s, when it became very apparent that you could not just build an aircraft, and then certify it fit-to-fly; just by inspecting it. Quality had to be built into every manufactured part and every construction process. Opinions were out and documented company approved practices and procedures were in. Quality Management was born, not an event - a process - a mindset and a step change. Years later the same problem became apparent to the medical regulators, and cGMP appeared. The inspection and assessment of quality became extremely important, and assessing your suppliers became mandatory. Documents such as IQ,- OQ, - DQ, - PQ,- VRA,- VP, - URS, were born.

When you completed your last quality audit - just how important did you consider your documentation to be? Just how clearly was the justification for your final decision on the client's cGMP compliance defined? Were you biased at all? Were all your priorities correct?
Could your decision stand up to senior management evaluation? Could it stand up to cross examination in a court of law? Are you certain that your findings are correct? All sorts of questions are asked and and allegations made when an audit goes wrong for a GMP vendor.

This why the quality of your GMP audit documentation is of paramount importance. You must always make certain that you are going to be ‘squeaky clean’, every question, and every answer and observation, needs to be clearly documented. The company priorities must be understood and integrated into the weighting of the audit documents. If you are auditing on behalf of a client, they have a right to review your completed assessment documents and agree or disagree with your verdict.

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The Importance of The Analysis.

The step-by-step, systematic approach used in this audit document, makes it easy to complete the Kepner Tregoe (KT) analysis. It can be very useful where there are many potential options to consider, since the KP analysis allows you to adjust the significance or to "weigh" the importance of each attribute that is listed in the user requirements specification.  Once this is action has been completed; the really important attributes can be identified and planned for.

Once the KT analysis outcome is deduced and published, the complete procurement process can be accurately defined and planned.

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GMP Vendor Auditing Scope.

A quality assessment questionnaire must cover the under listed topics but it must use a method of weighting the topics in order that the really critical topics have a more significant impact on the quality assessment outcome.

• General.
  
• Organization & Personnel.
  
• Facilities
  
• Equipment.
  
• System Integration.
  
• Development Plan.
  
• Test Plan.
  
• Configuration Management.
  
• Customer Support.
  
• Product Security.
  
• Change Control.
  
• Quality Systems.
  
• Document Control.
  
• Program Documentation.
  
• Documentation Management
  

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