The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list. And while you know you should set up a complete FDA inspection preparedness program, you just don’t have the time or proper resources to do so.
When a specific investigator arrives, you have a short time to get you and your team up to speed on his or her specific areas of focus. Often, your email to your department starts like this…
“FDA investigator Peter Baker just arrived at our site, and issued a form 482 announcing an inspection. He is conducting a for-cause inspection based on a recall of a sterile drug product we (the firm in question) issued last month.”
How does the rest of the email go? Well, that depends on how quickly you can access and synthesize critical information about Peter.
This article walks through 8 steps to get you and your team as ready as possible in the short time that you have.
1. Start with the metrics.
- How experienced is your FDA investigator?
- How tough are they — what is their 483 issuance rate for companies like yours?
- How many Warning Letters have resulted from inspections they conducted?
- Who have they inspected in the last year and what have been the results of the inspections?
For Peter, here is what we found: Wow, this guy has conducted inspections resulting in 29 Warning Letters! 70% of his inspections in the last year resulted in issuance of 483s.
You’d better do some deep dives to figure out what he might be looking for.
2. Then look at his inspection and co-inspection history.
- Where has he been inspecting?
- Has he focused on a particular type of site?
- Do you know anyone at those companies that might be willing to give you any details (even anecdotal)?
For Peter, here is what we found: He has primarily conducted inspections in China for the last couple of years, and prior to that, his attention was centered on India. He concentrates on Human Drugs and seems to only cite 21 CFR 211. Also, he seems to be focusing on “drug substance” or API facilities because he is not issuing as many 483s with 21 CFR 211 citations in the last 3 years.
I also want to see who the other investigators are that Peter has worked with in the recent past. I know he’s partnered with Thomas Arista who is a national expert in sterile drug manufacturing. And, thus, he’s probably picked up knowledge and expertise from Thomas, as well as maybe some auditing ‘style’ approaches.
3. Contact your friends.
They might not respond. Or, if they do respond, they might not be able to share confidential information. But maybe they’ll be a good shoulder to cry on?
4. Then look at the CFRs.
For Peter, he seems to concentrate on laboratories, procedures, and written records.
5. Filter down the document “corpus” to only include the items you care about.
We have 65 483s, 9 EIRs, and 29 Warning Letters – which ones should you focus on?!
Let’s apply some filters to ensure that we only focus on the critical documents. In Peter’s case, I would want to examine his last 3 years of work, where he has been inspecting in China.
Let’s apply the following filters:
- Inspector: Peter Baker
- Region: APAC
- Year(s): Last 3
- Inspection Type: Human Drug
- Issue Type: Let’s examine “Cross Contamination” issues
Results: there were 39 total inspections and then 17 Forms 483 in stock that matched these filters.
Check out this 2 minute video to see how I did this:
6. Skim the filtered down documents: 483s, Warning Letters, and EIRs.
Of the 17 inspections that matched my filters, 6 of them resulted in Warning Letters. I will focus on those for my quick research. First up is Zhejiang Medicine Co. Ltd. 8/4/16. Let’s see what we find:
Here is an excerpt from the Warning Letter:
“Our inspection found that analysts performed multiple gas chromatography (GC) analyses of (b)(4) samples for residual solvents. Analysts performed these unofficial analyses and recorded them in separate “R&D” folders before conducting the officially reported sample analyses. The original, unofficial analyses stored in separate R&D folders were not part of the official quality control records for your API, and your firm did not consider the results of these unofficial analyses to evaluate the quality of your API or make batch release decisions for numerous batches of API. Our investigator reviewed chromatograms found in the R&D folders and noted that some displayed large unknown peaks that were not reported in the official records for the same samples. The presence of such peaks in the chromatograms may indicate the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs.”
7. Search for Peter Baker on Google/LinkedIn.
Here’s what we found after a couple minutes of searching:
- Acting Associate Director for Medical Product Investigations in the FDA China Office
- Previously spent 2 ½ years inspecting pharmaceutical firms in India
- He has a master’s degree in Analytical Chemistry
- Speaker at the PDA Data Integrity Workshop in Beijing, China in June 2015
- Before his work at the FDA, he worked in the pharmaceutical industry
- He’s a seasoned, serious investigator who has been physically threatened on some of his inspections by the firms that he is inspecting: http://www.financialexpress.com/archive/usfda-says-team-threatened-during-wockhardt-inspection/1255079/
- He has a solid 5 o’clock shadow (see below)
8. Get everyone organized and write the email for the team.
FDA investigator Peter Baker just arrived at our site and issued a form 482 announcing an inspection. He is conducting a for-cause inspection based on a recall of a sterile drug product we (the firm in question) issued last month.
Peter has a background in analytical chemistry and significant experience inspecting in India, China, as well as the US.
Approximately 70% of his 152 inspections resulted in form-483 issuance over the past five years. In addition, his inspections have resulted in 29 warning letters over the past 7 years.
He has demonstrated expertise in at least two areas:
- In-depth evaluations of analytical processes, electronic data, data governance, and data integrity.
- Sterile drug processes including media fills, aseptic processing, and environmental monitoring.
Treat him seriously and address his questions honestly.
Ensure that administrators of laboratory and manufacturing computer systems are available and ready to work with him.
It’s Easier than You Think to Get Started
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