Still Another FDA Data Integrity item / checklist - or better yet "Again?"
This is not the first time I have prepared an article for LinkedIn on Data Integrity - why do I suspect it will not be the last? Probably experience, but I digress. The first one posted here goes back a few years - well, actually SEVEN years this month; that was a surprise. If you care to, revisit this for context [ https://www.dhirubhai.net/pulse/those-who-say-us-fda-isnt-clear-its-requirements-data-english-hccp/ ] before we go on into APR 2023, although the text below is abstracted from a warning letter dated 22 NOV 2022, it was only posted today.
The letter itself covers any number of subjects including OOS, testing into compliance and the 'use & abuse of FTIR." After covering several categories of failures, this 'checklist' gives an update to the FDA's current approach. Here is the full text of that section for your review. I have added two paragraphs 'for emphasis' at the end, as well as a hopefully minimal amount of emphasis in the section below. The link to the full letter is at the end.
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Data Integrity Remediation
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document?Data Integrity and Compliance With Drug CGMP?for guidance on establishing and following CGMP compliant data integrity practices at?https://www.fda.gov/media/119267/download.
We strongly recommend that you retain a consultant highly qualified in data integrity assessment to assist in your remediation. In response to this letter, provide the following:
1. comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
a) A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
b) Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
c) An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity lapses.
d) A comprehensive retrospective evaluation of the nature of the (testing/manufacturing/other] data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.
2. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
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3. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
a) A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
b) A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
c) Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding batches to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
d) Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.
e) A status report for any of the above activities already underway or completed.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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Since this is a domestic US firm, in NJ of course, there is no ability to have an Import Alert. (And if memory serves, the local pharmacy has sold our household some of their products ... something else to address in the near future. The irony in their name is not lost on me ....) For a full reading of the letter, follow the link: Aspire Pharmaceuticals, Inc. - 630328 - 11/22/2022 | FDA
Finally, in a nod to the dates on-going and upcoming, may you have a blessed and peace-full weeks for reflection and celebration. Your comments are welcome, as always.
Ayudo a Laboratorios de Control de Calidad en su transformación digital / Emprendedor y creador de Ez-LIMS software
9 个月A good LIMS can help establish controls to avoid many of the situations presented in this warning letter.
Former FDA Officer Freelance FDA Consultant
1 年Ok full disclosure, I was never the same after 2YK and the fact I am an exFDAer, I don’t even trust my dog unless he shows me a formalized, signed document. That said, John data integrity is in my opinion the place you can lie like a politician and claim it was unintentional with results of the greatest intend. It is the only space where the boundaries are space and not permanent, meaning the manufacturer of it or should be better said the collector can move the cones, at times when only he/she knew where the cones were originally. It is an in between space where few aside from some nerd at FDA actually carefully we hope scrutinizes. Everything and everyone wants what that data points to, where the real Mika, dough, dinero, bucks are. At the end folks like you and some others maybe mou, seek to dig to to see if we find mistakes? Fraud? Lousy math skills? Keep digging my friend and don’t expect the long arm of the law to do something with what we find.
President Quality Systems
1 年Data integrity issues continue in large part due to the fact that our industry is expanding so rapidly, individuals in key positions lack the knowledge and experience to be able to deal with it
I came back to this. The crime is data falsification at the point of initial gathering. Data integrity failures are corruption of it at some point in its later use. If you didn’t know it was misreported initially looking at the data sometime later seeing it the same you would accept the firm’s handling of the data and not detect the initial criminal act.
Retired Pharmaceutical Executive
1 年Seems to me that FDA is not doing its job. Injunction and seizure would be appropriate remedies.