Your company can improve its productivity by improving the writing skills of its technical people. Poor writing skills may
not show up on a balance sheet, but they can be a big problem. A one-month delay in getting FDA approval - due to ambiguous
writing - can cost a company millions of dollars.
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).
Organize your information
You can't afford to wing it. You need to plan the order of your thoughts, then reveal that plan to your reader. Use a summary
to announce your topic as well as to set forward a mini-map of where you are going. Readers will follow you almost anywhere
if you tell them ahead of time the order of your topics. The use of outlining, subheads, and anything else you can do to let
readers know your aims in the next few paragraphs or pages is very helpful. Don't start with a long-winded dissertation on
the background of the project or experiment. Instead, get to its purpose - what, why, when - before you start going into too
much prefatory material.
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
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.
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.