GMP TRENDS, INC. | Example - Laboratory Controls


DISTRICT ADDRESS GMP Trends Inc. P.O. Box 8001 Boulder, Colorado 80306			DATE OF ISSUE Introductory
			C.I. ISSUE Issue # MMXIX
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED To: Responsible Person, Director of Quality Assurance
FIRM NAME Pharmaceutical and Related Industries		STREET ADDRESS 5600 Regulation Lane
CITY, STATE AND COUNTRY United States of America and Worldwide		TYPE OF ESTABLISHMENT INSPECTED Pharmaceutical and Related Industries
During a review of inspection reports of U.S. firms (i) (we) observed: EDITED EXCERPTS FROM ACTUAL 483 OBSERVATION REPORTS BY FOOD AND DRUG ADMINISTRATION INVESTIGATORS Laboratory Controls .....Reports of analysis from component suppliers are accepted without establishing the reliability of the supplier’s analyses through validation of the supplier’s test results at appropriate intervals. Specifically, testing of incoming raw materials includes identity/assay testing for ..... products, and a review of the COA. Audits of raw material suppliers, including active pharmaceutical ingredients, fail to adequately establish the suppliers analyses in that the audits consisted solely of questionnaires sent to the suppliers to determine compliance with cGMPs. .....Laboratory controls do not include the establishment of scientifically sound specifications and test procedures designed to assure that components and drug products conform to appropriate standards. Specifically, The Quality Unit has not evaluated impurities found in the Active Pharmaceutical Ingredient or the finished dosage forms for ..... Unknown impurities have been were observed as high as 0.41% in this product. The Quality Unit does not monitor Impurities in finished dosage forms that were identified in vendor active pharmaceutical ingredient Certificates of Analyses. Unknown impurities are not evaluated unless they exceed a value of .....% for an individual peak as per your method. The firm’s analytical methods are unable to differentiate between unknown impurities and those impurities identified as excipient peaks in finished drug product such as ..... .....The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. Specifically, there was no validation data for the HPLC ..... software that addressed system operation, system maintenance, change control, data back-up and archival, and system security. This software is used to process data to support the release of multiple drug products. Also, there were no SOP’s describing software use and maintenance or any documentation regarding analyst training. Additionally, the analysts had access to a command that could be used to delete data files. .....Failure to perform Performance Qualification (PQ) for the High Pressure Liquid Chromatograph (HPLC) systems. Specifically, for all ..... HPLC systems, no performance qualification is performed on the detector, pump, oven and auto injector. In addition, firm failed to monitor the lamp hours and the energy of their HPLC UV-VIS lamps after 2000 hours of operation as recommended by the manufacturer. .....The quality control unit was deficient because it did not fully investigate errors that occurred. Specifically, there was no initial assessment of the out of specification (OOS) on the Content Uniformity analysis by HPLC for the ..... interval sample. Per SOP ....., the initial assessment of the investigation should have addressed analyst training review, data review, historical review, equipment review, materials review and method review prior to retesting the sample. .....Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. Specifically, records necessary in conducting an adequate annual product review could not always be located and were not available for review. For example, CAPA (corrective and preventive action) reports and investigation reports to include OOS (out of specification) reports could not always be located. In addition, an OOS log is not maintained to record, track and trend OOS results observed in the microbiology or chemistry laboratory. Maintaining an OOS log was a previous point of discussion on the inspection conducted .....
SEE REVERSE OF THIS PAGE	EMPLOYEE(S) SIGNATURE GMP TRENDS INC.	EMPLOYEE(S) TITLE Editor	DATE ISSUED Introductory

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Laboratory Controls

.....Reports of analysis from component suppliers are accepted without establishing the reliability of the supplier’s analyses through validation of the supplier’s test results at appropriate intervals.

.....Laboratory controls do not include the establishment of scientifically sound specifications and test procedures designed to assure that components and drug products conform to appropriate standards.

.....The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.

.....Failure to perform Performance Qualification (PQ) for the High Pressure Liquid Chromatograph (HPLC) systems.

.....The quality control unit was deficient because it did not fully investigate errors that occurred.

.....Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.