RPG Life Sciences Limited
Product: pharmaceuticals.
Date: 5/28/2013
Our investigator observed specific violations during the inspection, including, but not limited to, the following:
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
Additionally, during an audit of the data submitted in support of the (b)(4) regarding (b)(4) tablets USP (b)(4) mg, our investigator requested to review the electronic analytical raw data to compare the values for (b)(4) assay and degradation products. However, your firm provided only the printed copies of the raw data because your firm did not have the software program available to view the electronic raw data.
Your firm failed to establish and exercise adequate controls over computers to prevent unauthorized access or changes to electronic data.
For example, the computers that control your analytical laboratory instruments, including an HPLC, (b)(4) GCs, and an FTIR, lacked control mechanisms to prevent unauthorized access to, changes to, or omission of data files.
a. Your analysis of (b)(4) USP batch (b)(4) exceeded the (b)(4) residual solvent limit on February 29, 2012. Your firm did not report or investigate this OOS result, and deleted the related electronic records. During our inspection, your analyst admitted that he also deleted other uninvestigated failing and/or OOS electronic data from the laboratory database in January 2013 prior to our inspection. Your QC Senior Manager also acknowledged this laboratory-wide electronic data deletion practice.
b. During our inspection, your analysts demonstrated to our investigators that they could delete any electronic analytical data files from the laboratory computers and external backup hard drives.
Adequate controls prevent improper deletion of essential data. You stated in your response that you are procuring a centralized server and software, which will prevent electronic data deletion. Each analyst will have an individual user ID and password. You also trained your analysts not to delete electronic analytical data and report all laboratory incidences to managers. We will verify the effectiveness of these corrective actions during our next inspection.
You are responsible for the accuracy and integrity of the data generated by your firm. A firm must maintain all raw data generated during each test, including graphs, charts, and spectra from laboratory instrumentation. These records should be properly identified to demonstrate that each released batch was tested and met release specifications.
FDA District Office: CDRH
