Inspectional Deviations for Additional Workshop Exercises
#1. The training program is limited to reading SOPs and does not require a demonstration of proficiency in job-specific procedures
#2. No testing has been performed to certify any of your laboratory standards as secondary standards (e.g., testing against USP primary standards). The secondary reference standard in use has not been qualified.
#3. Accuracy, sensitivity, linearity, LOD, LOQ, and/or specificity were not assessed in the method validation.
#4. Laboratory controls are deficient in that your firm has established procedures that allow for the averaging of out-of-specification (OOS) and within-specification analytical test results from separate sample runs
#5: xxThe audit trail function for the chromatographic systems was disabled at the time of the inspection.
#6. xxYour firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for the US market, in order to verify the accuracy of the results obtained.
#7. Xx No system suitability testing was performed to ensure that the system is operating properly
#8. Failure to maintain complete records of any modification of an established method employed in testing.
#9. Alternate methods were used without demonstrating equivalence to current USP methods.
#10.Method verifications for compendial tests are not performed.
#11: xxA QC operator interviewed during the inspection stated that integrations are performed and re-performed until the chromatographic peaks are “good”, but was unable to provide an explanation for the manner in which integration is performed.
#12. Xx Your firm's review of laboratory data does not include a review of an audit trail to determine if unapproved changes have been made.
#13: xx Methods that were validated at one facility and transferred to another site are being used without method transfer or revalidation protocol
#14: The calibration procedure for HPLC systems is inadequate in that it did not include the detector linearity, injectorreproducibility, and the accuracy of temperature settings for the column heater.
#15: Reserve samples from representative sample lots or batches of drug products are not examined visually at least once a year for evidence
Responding to Inspectional Deviations (Warning Letters or 483 Forms)
Deviation #:
Route cause (Should answer the question – Why did the problem happen. If it is not obvious from the deviation report, define one and only one for this sheet)
Corrective Actions: Answers the question - how to fix the cited issue on that specific example. This can also answer the question, how the deviation could have been avoided. Should address the root cause.
Preventive actions: Answers the question – How can you ensure that this or similar problems will not happen any more in your lab on other systems and records, at your site, at your company?
Documents to be developed:Examples are SOPs, master plans, checklists, corrective action plans