SMB Validation

What does a PQ contain?

The Performance Qualification Protocols include (but are not limited to) the following common sections:

Identification of Writer, Approvers, Executors and Revision History:
Provides documented evidence on the personnel involved in preparing and executing the protocol complete with samples of signatures, initials and date formats. A revision history is maintained to record any changes to the document and the date they occurred.

Objective, Acceptance Criteria, and Identification of Test Equipment Required:
Defines the intent and limitations of the protocol and specifies the quality critical functions of the equipment. Specifies the criteria for a successful implementation and provides the customer with a list of test equipment to supply.

Equipment/Process Description:
A detailed written description of the entire system is included so as to provide the less-informed reader with the level of information required to gain comprehensive understanding of how the system as a whole is designed to operate.

Listing of Test Run Components:
A complete list of all the test runs that will be performed in the qualification including all the required components, run time for each run, nominal line speed, expected net output, and sampling plans.

P.Q. Testing:
This section will document the actual results from the Performance Testing and will include Equipment Settings, Downtime/Instantaneous Rates, Line Reject Classification, All required line verifications (count accuracy, fill accuracy, bottle attributes, removal torques, label attributes, carton attributes, bundle attributes, etc. - verification will be dependant on product being produced/packaged).

P.Q. Notes, Appendices, and Test Incidents:
These sections are provided to allow for proper documentation of any unforeseen occurrences during protocol execution.

Close Out and Sign Off:
Final approval of the executed document by authorized personnel is required in order to close out the document.