How do you create your own GMP documentation and records system?

1 Define your scope and objectives

The first step is to define the scope and objectives of your GMP documentation and records system. What are the products, processes, and activities that you need to document and record? What are the regulatory requirements and standards that you need to follow? What are the goals and benefits that you want to achieve with your GMP documentation and records system? By answering these questions, you can establish the purpose, scope, and boundaries of your system.

2 Identify your documentation and records types

The second step is to identify the types of documentation and records that you need to create and maintain for your GMP system. Documentation and records can be classified into different categories, such as policies, procedures, specifications, protocols, reports, forms, logs, labels, and certificates. Each type of documentation and record has a different function, format, and retention period. You should also consider the level of detail, accuracy, and completeness that each type of documentation and record requires.

3 Design your documentation and records structure

The third step is to design the structure of your documentation and records system. How will you organize, store, and access your documentation and records? How will you ensure consistency, clarity, and readability across your documentation and records? How will you avoid duplication, confusion, and contradiction among your documentation and records? You should design a logical and user-friendly structure for your documentation and records system, such as using a hierarchical numbering system, a document control system, and a records management system.

4 Develop your documentation and records content

The fourth step is to develop the content of your documentation and records. What information do you need to include in each type of documentation and record? How will you write, format, and review your documentation and records? How will you ensure that your documentation and records are accurate, complete, and up-to-date? You should develop the content of your documentation and records using clear and concise language, following the applicable guidelines and templates, and involving the relevant stakeholders.

5 Implement your documentation and records system

The fifth step is to implement your documentation and records system. How will you distribute, communicate, and train your staff on your documentation and records system? How will you ensure that your documentation and records are available, accessible, and secure? How will you monitor, measure, and improve your documentation and records system? You should implement your documentation and records system using effective methods, such as providing copies, online access, or training sessions; using passwords, encryption, or backups; and conducting audits, feedback, or corrective actions.

6 Maintain your documentation and records system

The sixth and final step is to maintain your documentation and records system. How will you update, revise, or retire your documentation and records? How will you handle changes, deviations, or incidents that affect your documentation and records? How will you archive, dispose, or transfer your documentation and records? You should maintain your documentation and records system using regular procedures, such as reviewing, approving, or notifying changes; documenting, investigating, or resolving deviations or incidents; and archiving, destroying, or transferring documentation or records according to the retention periods.

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?