Technical Writing in the Pharmaceutical Industry
Technical writing is not a new idea. Any type of communication written for and about industry and business with a focus on products and/or services is technical writing. Almost everyone within a company has written a form of technical document – from the résumé that was submitted to gain employment to the email sent to a co-worker to writing an investigative report. According to a survey of business leaders, as many as two-thirds of salaried employees have some writing responsibility, and all employees must have writing ability, especially with the increase in company email communication.
Technical writing skills are extremely important for any industry, but even more so when manufacturing pharmaceutical drugs. In this industry, if a batch record step is unclear or contains a mistake, it could have several types of negative consequences. Product could be unusable and clients could be lost if the mistake is caught. Employees could be hurt and lawsuits filed. Or, worse, the mistake could escape attention and end up impacting a patient, causing harm or death. The importance of good technical writing cannot be ignored as the science of pharmaceutical drug manufacturing depends on clear and accurate reporting. An otherwise meticulous document can appear flawed if it is poorly written wasting company time and resources.
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.
The Journal for Quality and Participation reports on several companies that lost big when it came to poor writing. Computer company Coleco eventually went out of business when customers who purchased its new line of computers found the instruction manual unreadable and returned the items. An oil company spent thousands of dollars to develop a new pesticide that had been written five years earlier by a technician in the same company but was so poorly written no one finished the report. A nuclear plant sent in a sales order for “ten foot long lengths” and instead of getting the ten-foot lengths they wanted, they instead received ten one-foot lengths. And, the list goes on.
According to the previously mentioned survey of business leaders, a little more than forty percent of companies offered or required additional training for employees with writing deficiencies. This training came with an annual cost of as much as three billion dollars. Add in the cost of poor writing resulting in liability to a company and that number grows substantially. Having just one staff technical writer could bring down this cost tremendously. Technical writers are diverse enough to fit into the pharmaceutical industry. Well-educated writers are able to explore a product and communicate its usefulness, process, what it means, and how it should be used clearly to the reader using as few words as possible.
In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require instruction documents like Standard Operating Procedures (SOPs) to be error free and written in an orderly fashion. It is as important for manufacturing documentation, reporting on problems, laboratory test methods, batch production records, etc. to all be crystal clear in its instructions. If employees are lacking in the skills to create crystal-clear, error-free instructions, then how are companies compensating for the deficit?
By having the necessary skills to research, understand complicated information, and tailor writing to many different readers, a technical writer within the pharmaceutical company is essential. By having a staff technical writer, companies can also save on training others within the company on the traits of technical writing. Any good technical writer can put together a session for others in the company detailing the traits common to technical writing and strategies for using them. Everyone within the company producing documents must be able to communicate detailed manufacturing procedures with simplification and directness reaching the end goal quickly and effectively. The steps must be written with extreme accuracy as lives depend on it.
A technical writing session for employees should include an introduction to technical writing. A brief description of clarity, conciseness, document design, audience, and accuracy are helpful. Then, the session should focus on strategies for using these traits in company documents like SOPs and batch production records. See Figure 1.
Figure 1: Technical Writing Strategies for SOPs
Clarity: say the same thing to multiple readers
Try to avoid words like some, several, many, few, substantial, often, and recently as they do not hold the same meaning for everyone.
Conciseness: help the reader to understand, do not present challenges to the reader
Avoid multisyllabic words, redundancy, prepositional phrases, and passive voice (the subject of the sentence should be listed at the beginning, not buried somewhere within the text).
Document Design: the document should breakup large chunks of text and look appealing to the reader in order to hold their attention
Use headers and sub-headings to draw attention, bullets for lists, tables and figures to highlight important information, and white space to break up large chunks of words.
Audience: write to the reader, if the document is for a wide range of readers with varying experience levels, a 6th grade reading level is the goal of writing.
What does your reader know, need to know, and want to know? Define acronyms and abbreviations the first time they are used.
Accuracy: important for clarity and professionalism
Use spell check but do not rely on it. Proofread. Let a peer read it, if not, then try reading it backwards to catch any mistakes.
By creating good quality content and having the necessary skill to tailor a document to achieve maximum clarity, technical writers can help achieve positive results for any business. More importantly, they can train others within the company to produce a more sound technical document. Customers and clients will value the consistent professional look in company documents and communications and will feel informed and trusting of the information provided to them. This, in turn, can bring in more customers and clients, increase value for stakeholders, and improve employee relations throughout the company. By hiring a technical writer, not only is your business going to increase but you save on the three billion dollars’ worth of training writing-deficient employees each year and decrease the problems resulting from unclear writing plaguing businesses.
Be sure to evaluate the technical writing capabilities of Contract Development and Manufacuring Organizations (CDMOs) before starting your next project. Piramal Pharma Solutions knows the importance of producing sound, technical documents in the pharmaceutical industry. We employ technical writing to ensure more understandable SOPs and facilitate more executable batch records. Clients appreciate the consistency among the documentation and our employees appreciate the clarity of instructions and guidelines. Overall, we are more efficient as our documents become more efficient.
“Writing: A Ticket to Work…Or a Ticket out: A Survey of Business Leaders.” The National Commission on Writing. 2004.
“Total Quality Business Writing.” The Journal for Quality and Participation. 1995.