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Home < Quality Assurance < FDA 483
Re: General GMP Audit by FDA conducted August 16-17, 1999 To Whom It May Concern: We are pleased to announce the results of the recent FDA audit of our laboratory. Two auditors, Mihaly S. Ligmond from the Pacific Regional Laboratory Northwest and Walden H. Lee from Los Angeles District, experienced analytical chemists, spent over one and a half days performing a general GMP compliance audit. A copy of the resulting Form FDA 483 is attached to this response. A summary of their investigation appears below. While here, the auditors reviewed many of our general lab SOPs and supporting data including training, analytical standards, data management, method validation, retest/OOS, notebooks, sample receiving and tracking, Y2K, computer validation, and metrology. They also inspected laboratory data for metals analysis, organic volatile impurities (both GC and GCMS methods), HPLC, FTIR, stability storage, and several USP General Tests. Because of the confidential nature of our work, WCAS obtained prior approval from our clients so that FDA could review data and results during the audit. Based upon the list of approved clients, we pulled recent data packages as specified by FDA. WCAS did not prescreen data. There are two findings noted in the 483. Our response to these items is as follows: 1. Data supporting stability of OVI standards. Such data has been acquired in the past, but it was not readily retrievable during the audit. It is our policy to establish the stability of standards by comparing the results of freshly prepared standards with older ones. We agreed to supply data to FDA within 6 mos. In the future, the results of such studies will be archived in the SOP for that method. 2. SOP on acceptable system suitability and continuing calibration agreement. While all of our SOPs have suitability criteria as well as continuing calibration criteria, FDA reviewed data for a test for which there was no SOP, a USP test that we do infrequently. The system suitability and sample analysis was conducted within the monograph guidelines on the first day of analysis. The next day, a continuing calibration standard was performed along with a duplicate sample analysis in order to fulfill our internal QC policies (which exceed the USP requirements). All samples passed specification, and the auditors did not question the soundness of the data. They did, however, feel that we should have some general guidance in an SOP for how well a continuing standard should agree with the system suitability when samples are analyzed on subsequent days. We agreed to provide the SOP by Oct. 1. D.J. Northington President / QA Officer |
