Unclear writing in this industry is understandable. There is so much technical information and so many numbers packed into typical biotechnology and pharmaceutical documents - SOPs, investigative reports, technical assessments, nonconformance memos, and process characterization protocols - that the quality and style of writing often takes a backseat to accuracy.
Many scientists write in fear, teetering between giving FDA too much information and too little. If they give too much, they may be opening up issues that they'd rather not broach; if they give too little information, they can be slammed for being incomplete, evasive, or unaware.FDA regulators have expectations. They want accuracy, but they also want the comfort that comes from reading a document that sounds authoritative because it is clear, error-free, and easy on the eyes. Poor writing - loaded with vagueness or wordiness or lacking parallelism and correct punctuation - can negatively influence any reader, including those who hold the fate of an application in their hands.
Five tips address the biggest writing problems among biotechnology professionals. (Other writing problems abound, so consult the "Better Writing Resources" sidebar for useful guides and reference materials.) Each tip is bolstered by examples drawn from actual documents (blanks are used to maintain confidentiality).
Be concise Conciseness is not the same as brevity. Brevity means being brief; conciseness means using the fewest words to get your message across. Here are a few examples of wordy sentences followed by concise revisions:
Original: "A minimum pH of 6.87 was observed during the process."
Revision: "During the process, the lowest pH was 6.87."
Original: "In order to meet the demands of the ______ industry, alternate methods of _____ must be developed."
Revision: "To meet the demands of the ______ industry, alternative methods of ______ must be developed."
Comment: In this revision, I cut two words and also changed "alternate" to "alternative," which is the word I believe the writer is after. Mark Twain once said, "Use the right word - and not its second cousin." "Alternate" strikes me as "the second cousin" because it means "to occur in successive terms."
Original: "The pH went down to 6.83 by the time corrective action was taken."
Revision: Use "fell to" or "dropped to" instead of "went down to."
Comment: The original sentence shows poor word choice.
Original: "Process characterization of the commercial manufacturing process can help ensure efficient validation, consistent process performance, yield improvements, minimize process excursions and aid in the investigation of process deviations."
Revision: "Characterization of the commercial manufacturing process is important because it ensures that validation is efficient, performance is consistent, and yield is improved as well as process excursions minimized and investigation of deviations aided."
Comment: There is no reason to settle for the repeated use of the word "process" throughout that sentence. Also, the revision helps keep the thoughts parallel. In other words, instead of some thoughts starting with verbs (ensure) and others with phrases that sound like nouns (yield improvements), all of the phrases should start with either verbs or nouns. You should not mix-and-match the two.
Keep it simple There is no need to use big words when small ones will do. Obviously you must use big words if they are the right words - such as the names of products, chemicals, or other proper names. However, try to take some of the starchiness out of your writing by asking yourself if a simple word would do as well or better than the word you've chosen. For example:
Original: "A scaled-down model for each unit operation must be qualified prior to initiating process characterization experiments."
Revision: "A scaled-down model for each unit operation must be qualified before starting process characterization experiments."
Comment: "Before" communicates the same information as "prior to" but more directly.
Be specific Even highly intelligent technical professionals occasionally get lost in their own thoughts. When this happens, they may write a phrase that is fuzzy and hard to picture. Usually, if an editor asks a writer what he or she means by a particular phrase, the writer will provide a new phrase that clears up the problem.
If documents aren't checked carefully, you may come across a phrase like the following one taken from an investigative report:
Original: "These experiments were scaled up to a large scale for final _______ production."
Revision: "These experiments were scaled up to commercial production."
Comment: Scaled up to a large scale? What exactly does that mean?
Don't leave phrases like "scaled up to a large scale" to the reader's imagination. When it comes to FDA reviews, vagueness is held against you.