Ltd.Ģ Coral Pharmaceuticals LTD 2 Apotex Research Private Limitedģ Torrent Pharmaceuticals Limited 3 JT Cosmetics Chemicals Pvt. Year 2019- upto 11/2019 (17 out of 36) Year 2018 ( 9 out of 57 from India)ġ Mylan Laboratories Limited - Unit 8 1 Skylark CMC Pvt. Warning Letters in India2018- 16, but 2019 47 It is not an India-centric or Asia centric.Data Integrity Issue is across the Globe.Is Data Integrity specific to country or region? Mismatch between reported data and actual data.Not reporting of failures and deviations.Not saving the actual electronic or deletingĮlectronic data after Printing- Chromatograms.Backdating/Postdating/missing /mismating.Unauthorised changes of post acquisition data.Selection of good or passing results ( exclusion.Wilfully falsification of data or fraudulent data.Discarding source documents after accurate.Use of non-validated software applications/Spreads.Changes due to software bugs or malware of which.Errors during transmission from one computer to.Ignorance (not aware of regulatory requirements.Know the difference between Poor/Bad practices.Bad practice historical practice, Shortcuts,.What are called Data Integrity breach ?.Innocent Ignorance Carelessness/ Negligence Intentional/ MaliciousĪct is unintentionalNon-Compliance isunintentional Act may or may not beintentionalNon-compliance isunintentional Act is intentionalNon-compliance isintentionalĭiscarding sourcedocuments afteraccurate transcriptionDeleting e-files afterprinting Inaction, inattention todetail, inadequate staff,lack of supervision Data manipulation, datafalsification, mis-representation, withholding criticalinformation What is Data falsification or fabrication?.FDA have a ZERO TOLERANCE policy for data.Manufacturing medicines for life-saving.Submitting false data to the FDA is a criminal.Questioning Data Integrity Loss of Trust.DOCUMENTED RECORD available to represent the.Assures the Quality, Safety And Efficacy of the.If they find compliance gaps, regaining trust.You to do the right thing when the regulatory Time period between the inspections, we trust.Data Integrity breach Break the trust between.Ultimately Pharmaceutical quality is to AssureĮvery dose is safe and effective, free of.Risk to quality is considered as importance. the protection of the patient by managing the
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |