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• Second (or even third) computer monitor

• Printouts of grant request for proposals and request 

for applications

• Templates for writers

• Glossaries from cancer centers or other stakeholders

• Digitally curating information

• Time tracking/management tools

• Optimizing software already in use

• Checklists and detailed project notetaking

 A medical writer’s ability to take on new projects 

depends on the scope and timeline for a given document. 

Clear communication, educating the client, and setting 

expectations and boundaries upfront are needed to ensure 

the project is completed according to the timeline, without 

compromising quality. In their presentation, Ms Byram, Dr 

Singleton, and Dr Chiavolini provided several strategies for 

assessing the ability to take on a project with a tight time-

line, as well as several tools for creating high-quality docu-

ments within that timeline.

Stephany Panlilio is a Senior Associate in Medical Writing at 
Gilead Sciences, Inc. (Foster City, CA)

Author declaration and disclosures: The authors note no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact: stephany.panlilio@gilead.com

* * *

TIME TO CLOCK IN: APPLYING MANUFACTURING 
BEST PRACTICES TO CONSISTENTLY AND 
EFFICIENTLY PRODUCE HIGH-QUALITY 
DOCUMENTS
Speaker 
Jenni Pickett, PhD, Whitsell Innovations, Inc.,  

Chapel Hill, NC

Mary Ellis Bogden, BA, Whitsell Innovations, Inc.,  

Chapel Hill, NC

By Stephany Panlilio, MS
Regulatory writing and manufacturing have many com-

monalities. As with manufactured products, regulatory doc-

uments should be produced at a reasonable cost, completed 

per an agreed upon timeline, be fit for intended purpose, 

and should meet a set of corporate, legal, and customer 

standards. What can regulatory writers learn from advances 

in manufacturing processes?

Manufacturing Best Practice Philosophies
Many modern manufacturing processes and principles 

came from the car manufacturer, Toyota. The Toyota Way 

operates under 4 driving principles.1 These principles can 

also be applied to medical writing, as described below.

• Long-term Philosophy – Forward Thinking.

  Focusing on the processes used to create products or 

documents can help improve efficiency over time.

• Add Value to the Organization by Developing Your 
People and Partners.

  In manufacturing and regulatory writing, ensuring 

that team members have the right skills is essential.

• The Right Process Will Produce the Right Results.

  A robust process will ensure a high-quality product.

• Continuously Solving Root Problems Drives 
Organizational Learning.

  Manufacturers and regulatory writers should develop 

and maintain a system to identify root causes and 

quickly address issues.

Good Regulatory Writing Practice
Manufacturers of pharmaceutical products must adhere 

to Good Manufacturing Practice (GMP) to mitigate risk. A 

robust GMP quality system includes training people; con-

trolling starting materials and equipment; clearly defining 

manufacturing, packaging, and storage processes; testing 

for quality; and documenting each step.

 To produce high-quality documents, the following are 

necessary: trained people, correct source materials that are 

up-to-date and easy to use, defined processes for the writing 

and review cycles, a quality control review process, and doc-

umenting each step (Figure). So, what would a theoretical 

good regulatory writing practice include?

• Developing the team by ensuring team members have 

the proper education, relevant experience, and knowl-

edge of regulations and company policies can help to 

reduce the risk of human error. Specific risks to your 

team can be evaluated by a gap analysis of critical 

skills. Cultivating a growth mindset culture in which 

employees feel comfortable being noisy in their igno-

rance helps identify critical training needs.

• Creating a Quality Document Profile, similar to the 

Quality Target Product Profile used in GMP, verifies 

the correct template, sources, interpretation, and  

team expectations are used for the document. Using  

a storage management system prevents errors due  

to use of incorrect templates, outdated data, or 

irrelevant sources.

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AMWAJournal.org     28Session Reports

• Protecting the data and text by using good data 

hygiene and limiting review cycles prevents transcrip-

tion errors, incorrect data interpretation, and inconsis-

tent text or messages within the document. Reviewer 

fatigue and consistency errors can be reduced by wait-

ing until the last review to write certain sections, such 

as the executive summary, synopsis, list of abbrevia-

tions, and summary of changes.

• Using risk-based quality control techniques can 

improve efficiency and ensure the most important 

areas in the document are correct. In GMP, Critical 

Quality Attributes (CQAs) are factors which would 

impact the overall quality of the product. Identifying 

CQAs in your document (ie, new data in an investiga-

tor brochure) can help your reviewer prioritize where 

to start.

• Recording the document development process in a 

tracker allows you to confirm you have followed all the 

key steps above and also see where improvements can 

be made.

• Reviewing your document development process peri-

odically will allow you to address new risks as you dis-

cover them and improve efficiency and quality over 

time. GMP uses Corrective Action Preventative Action, 

a system in which root causes are identified, and solu-

tions are proposed, verified, and implemented.

 Identifying risks throughout regulatory document pro-

cesses and finding ways to proactively mitigate them are 

imperative steps to creating high-quality documents. As 

regulations evolve and processes increase in complexity, 

implementing elements of a good regulatory writing prac-

tice provides a framework to focus on long-term invest-

ments in efficiency and quality of your documents by 

continually improving your people and processes.

Stephany Panlilio is a Senior Associate in Medical Writing at 
Gilead Sciences, Inc. (Foster City, CA)

Author declaration and disclosures: The authors note no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact:  stephany.panlilio@gilead.com

Reference
1.  Liker, JK. The Toyota Way: 14 Management Principles from the 

World’s Greatest Manufacturer. McGraw-Hill; 2004.

Figure. Elements of a theoretical good regulatory writing practice.

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