483
Company: Schering-Plough Prodcuts, LLC
City and State: Las Pierdas, PR
FDA District: San Juan, Puerto Rico
Dates of Inspection: 5/1-6/5-2001
You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999.
You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports. Analytical data generated by one employee can be reprocessed by another employee without the knowledge or consent of the original employee. For example, the analytical data generated for Celestone Soluspan Suspension, lots # 0-AHU-55 and 0-AHU-56 by one employee was invalidated and reprocessed by a second employee. The original employee denied knowledge of the reprocessing of the data. The computer record listed the original employee as sole owner of the record and did not indicate that any other individual entered or changed the record. There is no record to determine the identity of the individual who reprocessed the data.
