Workshops on Investigating Out-of-Specification (OOS) Results
|Event Date/Time: May 10, 2010||End Date/Time: May 11, 2010|
The essentials for conducting an investigation of an out-of specification result in a compliant, reliable, and timely manner include having a well-organized and understood process; having well-informed and well-trained analysts, supervisors, and manufacturing personnel; and maintaining clear and concise documentation. The firmâ€™s procedure for investigating out-of specification results should describe the various phases of the investigation and the recommended timing for the completion of the phases. The types of errors that may arise and how to deal with them should be defined. Checklists may help determine the presence or absence of certain types of errors. The procedure also should provide for the thorough documentation of the investigation.
The best practice is to minimize the generation of out-of specification results. Careful description of methods and reportable values, including appropriate system suitability parameters, can help to avoid out-of-specification results. Qualification of equipment and analysts and rigorous transfer of analytical technology will help to ensure that a laboratory is fully capable of performing an analytical method.
This two-day presentation will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. It will also offer guidance on how to establish or reestablish limits that are appropriate to the specific manufacturing process. There will also be discussion on how to document the results of the investigation.