Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here). The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.”
The guidance does have additional examples and clarifying language. In addition, the FDA notes that “[a] paragraph regarding independent security role assignments for small operations or facilities was removed because the guidance for industry “PET Drugs–Current Good Manufacturing Practice (CGMP)” covering this topic is sufficiently clear.
It is interesting to note that most of the data integrity issues addressed in the Q & A guidance address computers and their systems. There is a brief mention of fraudulent data that was the Waterloo of the late 1980s generic drug scandal. The posture of the Agency towards data integrity seems to have taken a turn over the years (as described in a previous post here). There are also numerous other posts on our blog that can be found simply by searching for data integrity on our website here. Whatever the changes in the FDA’s stance over time, based on its observations in FDA Form 483s and Warning Letters, the issue of data integrity is alive and well in the pharmaceutical industry. For additional information on data integrity and what you can do to address it at your firm, please contact the Lachman office in NY at 516‑222‑6222 or you can reach us by email at LCS@lachmanconsultants.com.