FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Please find the an attachment which contains writing an effective 483 response to the regulatory authority. Please feel free to request the copy if interested.
Handling of a fda inspection [compatibility mode]Kiran Kota
The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.
Just providing the information on Impurities in drug substances & Drug products to share my view and the collected information from the web for knowledge purpose.
"De route naar mensgerichte zorg "
Noodzakelijke verandering in de zorg heeft alleen kans van slagen als waardevolle initiatieven die nu genomen worden een gemeenschappelijke richting hebben: mensgerichte zorg in Nederland. Op de weg daarnaartoe geven de bakens van de zorgwaarde-agenda de juiste richting aan.
MAASTRO clinic is hét instituut voor radiotherapie dat de bestraling van kankerpatiënten in de provincie Limburg verzorgt.
We doen dat vanuit hoofdvestiging Maastricht en op locatie in Venlo. MAASTRO werkt intensief samen met zowel het academisch ziekenhuis Maastricht (azM) als de Universiteit Maastricht (UM).
Een samenwerkingsverband waarin we wetenschappelijk onderzoek verrichten, met o.a het azM, UM en GROW.
En dát is belangrijk om te kunnen blijven
innoveren in radiotherapie.
MAASTRO takes on cancer together with the patient and his or her relatives. Our fight against cancer is based around radiotherapy, scientific research and education. View also our general corporate presentation (on the left).The central aim of MAASTRO Clinic’s strategy is “individualised radiotherapy”. "Heading the charge for our patients!" or watch the short animation movie about Maastro's vision for cancer treatment.
FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Please find the an attachment which contains writing an effective 483 response to the regulatory authority. Please feel free to request the copy if interested.
Handling of a fda inspection [compatibility mode]Kiran Kota
The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.
Just providing the information on Impurities in drug substances & Drug products to share my view and the collected information from the web for knowledge purpose.
"De route naar mensgerichte zorg "
Noodzakelijke verandering in de zorg heeft alleen kans van slagen als waardevolle initiatieven die nu genomen worden een gemeenschappelijke richting hebben: mensgerichte zorg in Nederland. Op de weg daarnaartoe geven de bakens van de zorgwaarde-agenda de juiste richting aan.
MAASTRO clinic is hét instituut voor radiotherapie dat de bestraling van kankerpatiënten in de provincie Limburg verzorgt.
We doen dat vanuit hoofdvestiging Maastricht en op locatie in Venlo. MAASTRO werkt intensief samen met zowel het academisch ziekenhuis Maastricht (azM) als de Universiteit Maastricht (UM).
Een samenwerkingsverband waarin we wetenschappelijk onderzoek verrichten, met o.a het azM, UM en GROW.
En dát is belangrijk om te kunnen blijven
innoveren in radiotherapie.
MAASTRO takes on cancer together with the patient and his or her relatives. Our fight against cancer is based around radiotherapy, scientific research and education. View also our general corporate presentation (on the left).The central aim of MAASTRO Clinic’s strategy is “individualised radiotherapy”. "Heading the charge for our patients!" or watch the short animation movie about Maastro's vision for cancer treatment.