TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR). It was completely “rolled out†in October 2002. For each “Objectionable Condition†(FDA 483 Observation), TurboEIR requests the inspection team to choose a “canned†citation and then describe the details of the situation. In addition, each “canned†citation contains a paraphrase of the underlying authority. Quite often the underlying authority is a regulation from Title 21, Code of Federal Regulations, but may also be a statutory reference.
TurboEIR is strongly encouraged by FDA management for the purpose of writing accurate, consistent, and complete reports and documents as well as increase the efficiency of report writing.
Each team member who has a TurboEIR laptop can independently work on the Form FDA 483 on their own. However, because citations can only be used once per 483, significant communication and coordination is required. In some cases the analysts will write each Observation, locate the regulation within the CFR for that specific Observation and then locate the citations on the TurboEIR website. In these cases, the information is then provided to the Lead Investigator who will incorporate it into the Form FDA 483.
Investigators should be aware some of their Observations might duplicate manufacturing Observations of the same violated regulation. In these situations, the Observations are grouped under one citation. For many of the CFR regulations, there are multiple citations to choose from in TurboEIR, since there may be multiple ways for a firm to violate a given regulation. Care must, however, be taken in selecting the best citation for the violation(s) observed.
Because of the opportunity for the Investigator is choose from multiple citations, the astute follower of Form FDA 483s recognizes that some of the citations and their subsequent examples don’t always appear to completely logically follow. An excellent example of this relates to the use of 21 CFR 211.192 when 21 CFR 211.113 (a) or (b) should be used. For example:
21 CFR 211.192 Production Record Review states:
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.
21 CFR 211.113(a)(b) Control of Microbiological Contaminations states:
(a)Â Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
(b)  Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes
While these two citations appear completely different, they are often used interchangeably by Investigators. (Please see the author’s Blog entitled “Hemofarm A.D., Vrsac, Serbia Received Warning Letter (6/20/12) for Aseptic Processing Issues†which was posted on December 9, 2012. This represents an excellent example of a “cross-over†where one might question the use of 21 CFR 211.192 in lieu of 21 CFR 211.113.
Some Investigators that perform several inspections within a year will often print out the main or often used citations. Doing this allows the Investigator to read the citation on paper and discuss it with other Investigators whereas doing all on the computer may prove to become more cumbersome.
Please review the two following Blogs for the most frequently cited 2012 (April 24, 2013) and 2013 (March 20, 2014) Observations noted by FDA CDER. Please note that 21 CFR 211.192 is within the top five most frequently listed. One wonders how many of these “192†citations should have been “113�
Additional information on this subject may be obtained by attending the author’s Pharmawebinar sponsored by Tungstenshield.com on Wednesday, June 18, 2014 at 1 PM (EDST). The title for this webinar is “Deconstructing Warning Letters“ – Using Warning letters to Illustrate the FDA and Health Canada CFRs
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