Inspection Essentials: Critical Factors to Consider When Prepping for an FDA Visit
FDA inspections can glide smoothly or run off the rails, depending on how thoroughly and thoughtfully sites and sponsors prepare for them. Before the agency shows up, consider 10 key factors to gauge your inspection readiness.
1. Completeness of Archives
It’s critical to determine whether your archives contain everything an FDA investigator may request during an inspection, says David Chesney, principal and general manager of DL Chesney Consulting and a 23-year veteran of the agency’s inspectorate.
The key to a speedy resolution, he says, is to provide inspectors with exactly what they ask for, providing nothing additional that will delay resolution or provoke additional inquiries. In a recent presentation at the WCG FDAnews FDA Inspections Summit in Washington, D.C, Chesney advised doing a sweep of document archives to ensure they’re comprehensive, starting with this basic list. Look for:
- Meeting minutes, preferably archived and divided by session vs. grouped together in a single document;
- Emails and correspondence related to critical decision points;
- Historical team rosters;
- Updated job descriptions that reflect current duties;
- Curriculum vitae and current resumes of staff that perform regulated operations;
- Written verification of items removed, destroyed or replaced from the archives;
- Naming convention systems for electronic files and records; and
- Signature and initial logs.
2. File Naming Conventions
It’s also critical to have clear file names for records that, with any luck, are self-explanatory, Chesney says. Using a standard file name format is critical to rounding them up quickly and, importantly, for producing the correct document(s).
Electronic files may be viewed with software that only shows the first 24 characters of a filename. For example, a file that begins with the name “The Final Study Report for” will hit that character limit and offer little clarity to investigators; be sure that naming practices make electronic files easy to differentiate during an inspection.
For paper documents, look to see if file folders and indices are labeled appropriately to properly describe the contents and offer a complete understanding of what’s in them.
Also consider, for documents that are stored with a third party, whether the nomenclature used will create any difficulties in producing the correct document in a timely fashion when they get your call.
And for amended documents, understand where the amendments are kept — are they stored with the original or are they kept in another location by year, author, compound or study number?
3. Document Transfers
External document transfer procedures are also important to examine when preparing for an inspection. Consider if there are written requirements for in-house, remote or contracted employees and vendors to transfer content into the archives. Also, determine what the frequency of transfers is, where documentation of transfers is located and where the records were located prior to transfer.
For example, remote employees may have kept their original training records in their homes and transferred these documents to a central office on a yearly basis. It’s important to have a firm understanding of how things such as this are documented, he says.
4. Original Documents
Sponsors should be aware of multiple versions of final documents that may exist in their archives and have documentation tracking them. For example, there could be a final version of a document written in one language, as well as an “original” document created for submission in a different language. Be able to speak to how these documents are differentiated and show how removal/destruction was documented if this occurred. In addition, if reference source documents are removed or destroyed, sponsors should have readily accessible documentation for this in the archives.
Also look to the written procedures of your organization to see if they define draft, final and original documents, Chesney recommends.
5. Draft Documents
Ask whether or not your archives contain draft versions of documents and documentation tracking how they’ve been handled over time, Chesney advises. If you do have draft documents, you should also understand what the differences are between the draft versions and their final iterations.
It’s important to know whether any draft documents have been reconciled, removed or destroyed, and if so, whether there’s documentation for their removal or destruction. This documentation should be accessible in the archives in case the FDA investigator wants to see it.
6. Contracted Archiving
Sponsors may enlist a third party to archive their records; before FDA shows up, it’s important to determine whether the contract in place allows for prompt access to these documents and if the third party will put inspection-related requests front and center on its list of priorities, says Chesney.
To this end, it’s wise for sponsors, prior to an agency inspection, to see if the contracted archivist has an emergency retrieval process established and if there’s a line of communication available at all times. It’s unlikely that the agency will show up at 2 a.m. on Christmas day, he says, but it’s good to know the archiving service will be available at any time to field document requests.
In addition, designate who is responsible for paying for document retrieval, what these costs are and who is authorized to request documents.
7. Records Provided by Other Parties
Similarly, ask whether documents produced by other parties, such as CRO records, records managed by a consultant or records related to an acquired product, are readily accessible. And be comprehensive. The FDA might ask for seemingly obscure documents, such as records for pest control services enlisted by the sponsor, for instance. Assuming these records can be retrieved on a whim, it’s important to understand how they’re stored.
Additionally, consider if translations and/or certified copies will be needed for certain documents and have a plan for making this happen, he adds. Also ensure that records controlled by other parties are indexed so that they can be tracked down painlessly.
It’s not enough to be able to retrieve a given document at an FDA investigator’s behest — delivering documents in a timely fashion is also critical to hosting smooth inspections. Ask yourself: Can my documents be produced in a prompt and effective manner?
Remember that inspections can involve multiple parties across a range of time zones, Chesney cautions. For instance, Chesney took part in a mock inspection involving people from China, Europe and the U.S. West Coast, with Chesney participating from Maine. Strategies should be established that successfully address these time differences and varying delivery requirements.
Also keep in mind that the inspection might occur somewhere other than the physical location of the archives, such as through information management service companies if the sponsor is using them.
9. Access Security
It’s critical to assess an archive’s access security measures before the FDA shows up. Sponsors should evaluate who did the security testing, when it was conducted, what the findings were and what issues remain unresolved, if any.
10. Logistical Considerations
In terms of logistics, start by determining if the staff in charge of the archives have the proper access and resources they need to procure documents during an FDA inspection.
Be on the lookout for internal obstacles. Any electronic media, such as Cloud storage, jump drives and designated server drives, should function properly and be accessed without problems. It’s also a good idea to ensure there are basic office supplies, like paper clips, staples and tape, at the ready.
Unanticipated hurdles could be as simple as a lack of office supplies (such as not having all necessary sizes of copier paper) or nonfunctioning office printers, copiers and scanners, but they can and do come up during inspections, Chesney says. An investigator’s request for European contract development and manufacturing organization documents, for example, might require A4 paper rather than the standard U.S. letter size, so be prepared with proper paper sizes to allow for all possible requests.