SMB Validation

Why produce a PQ?

Performance Qualifications are required in order to ensure that the integrated system being qualified has proven to be operating to acceptable criteria, prior to packaging any saleable product. The IQ and OQ protocols document and test that each individual piece of equipment on an integrated system operates as it was designed. The Performance Qualification tests that each individual piece of equipment on the integrated system are able to operated together in order to achieve the required output on the integrated process. These tests must be performed and proven to pass the acceptable quality levels established for the particular integrated process prior to initiating actual production. Failure to provide proof that the integrated process functions as required results in production delays and high costs in product and components when the integrated process does not operate to acceptable quality levels.