ABSTRACT

THE final report is a compilation of all of the data, including dose maps, certification of verification and sterilization dose, bioburden and sterility test reports that support the successful completion of the validation. Generally, the report is organized in a notebook and contains the approved and signed protocol, all data and test reports from the dose verification experiment, and the approved and signed final report. The sections of the final report are as follows:

Title page

Purpose: state what the report contains or what validation has been successfully completed.

Scope: state the range of the project and any history or supportive testing performed prior to initiation of the validation.

Responsibilities: define in the protocol and do not repeat in the report.

Equipment/materials: define in the protocol and do not repeat in the report unless additional supplies and equipment were used.

Procedure: outline in detail the steps that were followed. If any deviations occurred, be sure to discuss them and the results. If changes to the protocol were required during the validation, the approved and signed Addendum should be included in the report.

Results: discuss the results from the dose verification experiment and determine if the results comply with the acceptance criteria defined in the protocol. Any rationale used to repeat the experiment or augment the dose must be documented.

Conclusion: state whether the data met the acceptance criteria. Discuss any deviations and any rationale for rejecting any dose experiments or test results.

100Requalification: define the time frame for revalidation of the process; the industry standard is quarterly. If acceptable dose audits have been performed for one year and the bioburden is in control, the audit frequency interval can be increased to every six months.

Approvals: obtain appropriate management approval of those individuals on the team responsible for the success of the validation effort.

Attachments: provide a copy of the radiation certification, and bioburden and sterility test data.