1 Understand the purpose and scope

Before you start writing any GMP document, you need to understand its purpose and scope. What is the objective of the document? Who is the intended audience? What are the regulatory and internal requirements that apply to the document? How does the document fit into the overall quality system and document hierarchy? Answering these questions will help you define the content, structure, and format of your document, as well as avoid unnecessary or redundant information.

2 Use clear and concise language

One of the most important aspects of writing great GMP documentation is to use clear and concise language. Avoid jargon, slang, abbreviations, and acronyms that may confuse or mislead the reader. Use simple and direct sentences that convey the meaning and intent of the document. Use active voice and avoid passive voice, as it can create ambiguity and weaken the authority of the document. Use consistent terminology and definitions throughout the document and refer to other relevant documents as needed.

3 Follow the document template and format

Another key aspect of writing great GMP documentation is to follow the document template and format that is approved by your organization. The template and format will provide guidance on the layout, headings, numbering, font, spacing, margins, and other elements of the document. Following the template and format will ensure consistency, readability, and professionalism of your document, as well as facilitate the review and approval process. If you are unsure about the template and format, consult your quality assurance or document control department.

4 Include all necessary details and evidence

A good GMP document should include all the necessary details and evidence that support the document's purpose and scope. For example, if you are writing a standard operating procedure (SOP), you should include the steps, roles, responsibilities, equipment, materials, and parameters involved in the procedure. If you are writing a validation report, you should include the validation plan, protocol, results, analysis, and conclusion. If you are writing a deviation report, you should include the root cause, corrective and preventive actions, and impact assessment. The details and evidence should be accurate, complete, and verifiable.

5 Review and revise your document

Before you submit your document for approval, you should review and revise it to ensure it meets the quality and compliance standards. You should check your document for spelling, grammar, punctuation, and formatting errors. You should also check your document for clarity, consistency, logic, and relevance. You should ensure your document aligns with the current policies, procedures, and regulations. You should also solicit feedback from your peers, supervisors, or subject matter experts who can provide valuable insights and suggestions for improvement.

Writing great GMP documentation is not an easy task, but it is a vital skill for anyone involved in the regulated manufacturing industry. By following these tips and tricks, you can write GMP documentation that is clear, concise, accurate, complete, and compliant.

6 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?