What are the best practices for creating technical documentation in the pharmaceutical industry?

1 Know your audience

Before you start writing, you need to identify and understand your target audience, their needs, expectations, and level of expertise. For example, are you writing for regulators, health professionals, patients, or internal stakeholders? Depending on your audience, you may need to adjust the tone, style, format, and content of your document. You should also consider the cultural and linguistic differences of your audience, especially if your document will be translated or used in different regions.

2 Follow the standards and guidelines

The pharmaceutical industry is subject to various standards and guidelines that govern the content, structure, and format of technical documentation. For example, you may need to follow the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the Food and Drug Administration (FDA), or other relevant authorities. You should also adhere to the internal policies and procedures of your organization, such as document templates, style guides, naming conventions, and approval workflows.

6 Maintain and update your document

Technical documentation in the pharmaceutical industry is not a one-time task, but rather an ongoing process that requires maintenance and updates. You need to monitor and track any changes or developments that may affect your document, such as new regulations, data, or feedback. You also need to ensure that your document is accessible, secure, and traceable, using appropriate document management systems and tools. You should also communicate and collaborate with your stakeholders, such as colleagues, clients, or regulators, to keep them informed and involved in your document lifecycle.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?