Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

In case of serious violations of GMP requirements, the American FDA issues a Warning Letter to the company in question. The company must react to this within 15 working days and submit a corrective action plan to the FDA.

The FDA inspected the Hungarian company Teva Pharmaceutical Works Private Limited from 21 to 29 January, 2016 and the inspector witnessed serious violations of GMP requirements. The company's reply on 22. February 2016 was not sufficient and led to a Warning Letter issued on 13. October 2016. The violations were considered to be so serious by the FDA that the company was put on import alert already on 27 May 2016. In our previous GMP News Part one and Part two we already reported about other deviations found at the facility

The violations observed are referred to the respective GMP requirements of 21 CFR Part 211 by the authority. In this case, the deficits were divided into 7 different chapters.

In this third part, we have covered the violations of 21 CFR 211.194 "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards" and 21 CFR 211.68 (b) "Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records".

With regard to 21 CFR 211.194, the inspector criticised that the documented colony counts for environmental and personnel monitoring did not correspond to the number counted by the inspector. This was observed at least on six contact plates but without naming any further detail.

Concerning 21 CFR 211.68, it was criticised that insufficient measures for stand-alone computer systems had been in place to prevent from potential data losses. The measures listed included routine audit trail review and full data detention. Although a procedure to begin reviewing audit trails of an HPLC system had been implemented on 11 January 2016, not a single review has been performed prior to the inspection. Furthermore, it was criticised that this procedure only required random audit trail review.

The company's statements to both strengthen the procedures on access control and to implement the audit trail functionalities in the computerised systems were considered insufficient with regard to the data integrity issues observed. The FDA now expects from the company a retrospective review of all HPLC and other laboratory data. The company shall also justify to the FDA its rationale for selecting the timeframe.

Source: FDA Warning Letter to Teva Pharmaceutical Works Private Limited Company

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