Writing: The FDA Compliance Problem No-One Talks About

Jack Garvey |

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is that if it wasn’t documented, it didn’t happen. An FDA-regulated manufacturer’s documentation is the only way in which it proves its compliance with applicable regulations; the way in which it communicates its activities to the agency. And in this context, poor writing equals poor communication. 

A January 2019 Bloomberg article on quality issues discovered at a Mylan manufacturing facility—including falsified quality test data—highlights the important role that data and document review play during FDA inspections. This is not a new issue. CNN, in a 2013 article regarding Ranbaxy’s guilty plea to felony charges related to the manufacture and sale of adulterated drugs from two Indian plants, noted:

The heart of good manufacturing is documentation. Without it, there is no way to verify quality, investigate problems, or know whether your drug will improve health or harm it. Because the most minuscule changes can make the difference between a robust product and one that degrades and becomes toxic, each step must be recorded and validated. Any misrepresentation, mixing of data streams, or deviation from procedure invalidates—and potentially adulterates—the drugs.

And inadequate writing skills are arguably behind many—perhaps even most—of the problems noted during inspections of pharma and medical device manufacturing facilities. The evidence? Many Warning Letters include such phrases as “failed to explain,” “lacked rationale,” “failed to justify rationale,” “lacked evidence,” “failure to establish,” “did not provide sufficient information” and similar statements. All of these are red flags that can signal a problem with how companies are writing the outcome documents reviewed by FDA investigators during inspections. 

This has not gone unrecognized within the industry, though the topic is rarely discussed in public. Experts have noted that sub-par writing is endemic within the pharma and medical device industries. For instance, Piramal Pharma Solutions, a contract manufacturer, noted in a blog on its website that “[t]echnical writing is not a new idea” and that “[t]echnical writing skills are extremely important for any industry but even more so when manufacturing pharmaceutical drugs,” noting various potential consequences, such as patient harm, unusable product and lost clients. The blog continues with: 

It is difficult, however, to find employees who have content knowledge of their profession and also the skills needed to write a technical document. It is even rarer to find an employee who has taken a course in technical writing, and, as many colleges do not offer technical writing as a concentration in the English department, it is even harder to find an employee who has a degree in technical writing. With this information, it is not hard to believe the statistic that one-fourth of college graduates are not only poor writers, but lack proper communication skills altogether.

One Washington, DC Food and Drug attorney characterized regulatory writing throughout the industry as “horrific” much of the time. Another Food and Drug attorney, a former FDA official now with a large Washington, DC-based law firm, noted that he spends a lot of time reading internal company documents unable to puzzle out the meaning of the reports. His pricey billable hours are often spent writing margin notes querying, for instance, how information relates to the SOP or asking for clarification on particular sentences or paragraphs. 

And while a company’s lawyer will take the time and put forth extra effort to gain clarification, no FDA Investigator will go to that much trouble. Rather, the Investigator will simply report what s/he sees as inconsistencies or lack of information in documents as 483 observations under the pertinent regulations. 

The Compliance Writing Problem 

There are many reasons why a company might find it difficult to ensure that its documents are well-written. Employees tasked with producing documents might lack skills and training to write well, or may not have enough time to craft good documents. Training in writing principles and techniques is generally not be included in training for manufacturing and quality employees, nor are likely among skills sought during the hiring process. 

In many cases, companies may just not emphasize—or even understand—how critical good writing really is. There can be a tendency within the drug and device industries to consider scientific and technical competence the be-all and end-all of compliant operations; this can lead to a lack of focus on the importance of writing for clear communication. Similarly, companies may fail to hone in on the regulatory basis for written documents, not considering their purpose, structure and usability to both internal and external readers. 

FDA Expectations for Writing 

What constitutes a good document for the FDA’s purposes? First and foremost, it must contain the information necessary to demonstrate compliance with regulatory requirements. That information must be based on sound technical and scientific principles. But it’s not enough for a company to believe—even to know—that its operations are scientifically sound and regulatorily compliant. If that information is not written clearly so that FDA Investigators will easily understand what is trying to be conveyed, it may not pass muster during an inspection. 

Bottom line: If a document does not clearly communicate compliant activities and record-keeping, FDA Investigators are likely to have issues with that, and those issues will probably be reflected in 483 observations.  

The Art of the Compliance Story 

Fortunately, good document writing is both an art and a process, which is rarely taught but can be learned. The heart of a good document is a story about compliant manufacturing, with no “plot holes” where specific regulatory requirements go unaddressed. In other words, the FDA expects that a required document will accurately mirror the activity it describes, allowing the Agency to accurately determine whether regulatory requirements are met. Any unclear documentation will be treated as a noncompliance. 

A well-told compliance story can be assured by applying a careful process to all compliance document development and writing. Companies should apply this process to all documents that could be subject to FDA review during inspections or otherwise. These include problem-solving records that address such things as CAPA activities, including supplier CAPA, investigations of product non-conformances, batch failures and complaints, design or manufacturing changes and service reports.  

Also pertinent are technical records, like quality or regulatory plans, design review documentation, design transfer reports, verification and validation reports, equipment qualification reports, risk management reports, human factors analyses, clinical study results and regulatory submissions. A simple, seven-step process—which Compliance Architects® will discuss in more depth in future articles on this topic—can help ensure that compliance documents are clearly and accurately written, greatly reducing the chance of FDA observations that will require significant time and money to address:

  1. Determine the purpose of each document, including clarification of what information needs to be provided to allow an FDA investigator to easily understand the activity described; 
  2. Determine and write for the target audience—typically the FDA, but possibly others, such as company management, suppliers, clinicians, notified bodies and other stakeholders—and their specific needs; 
  3. Ensure the structure of both the document, and content within the document, create an easy to understand, logically flowing story that mirrors the regulated activities; 
  4. Establish and explain, in detail, the situational and technical context of the activities described; 
  5. Investigate and/or analyze activities described in the document; 
  6. Develop conclusions from the investigation and/or analysis to the activities and events described in the document and ensure linkage to identified actions; and 
  7.  Conduct independent review—at both the peer and supervisory levels—before finalizing the document. 

The seven steps above can be applied to the documentation of virtually all regulated activities to minimize confusing, hard to understand documents that can lead to poor inspection outcomes.  Similarly, determining which documents pose the greatest inspection risks is a key skill for regulated manufacturers. Ultimately, companies should apply the steps laid out above to tackle the challenge of producing documents they know need to be inspection-ready. 

Over eight years ago, Compliance Architects® recognized that writing quality was a significant problem for FDA-regulated manufacturers and that poorly written documents contribute directly to poor inspection outcomes. Noting the paucity of good, relevant compliance writing training available to the industry, Compliance Architects® developed FDA-regulated industry’s first and only comprehensive workshop training program that helps companies learn how to write for compliance. Call Compliance Architects® at (888) 734-9778or email us at w4c@compliancearchitects.comto schedule your onsite workshop. 

Praise for Writing for Compliance®

97% of past attendees would recommend this course to others.  Attendee reviews include: 

  • “Great job. I enjoyed seeing the team work together to improve our business.” 
  • “Excellent course. Thank you, it has been inspiring.” 
  • “I found the course extremely beneficial to our job.” 
  • “Training is excellent.  Would definitely recommend.” 
  • “Training was very helpful on how to translate technical data to a readable report where it tells a story.” 
  • “Pace was good; allowed for deep dive discussions.” 
  • “Very well organized.  Very helpful.” 
  • “Thank you for the training.  All the information   was well thought out and in detail.” 
  • “This is directly applicable to my job.” 
  • “As a beginner in compliance writing, I feel that I gained a lot of perspective and good tips going forward.” 

One thought on “Writing: The FDA Compliance Problem No-One Talks About

  1. Its really one of the actual problem industry is facing and many conveniently ignored them. However, I do agree the skills some attorneys have in making consice documents from complex reports. A lot of efforts needs to be taken.

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