What are the most common GMP product development and design errors and how to avoid them?

1 Lack of user input

One of the most common GMP product development and design errors is not involving the end users or customers in the process. User input is essential for understanding the needs, preferences, and expectations of the target market, as well as identifying any potential risks, issues, or gaps in the product functionality or usability. To avoid this error, you should conduct user research, testing, and feedback throughout the product development and design stages, and incorporate the user insights into the product specifications, features, and design.

2 Poor documentation

Another common GMP product development and design error is not maintaining adequate and accurate documentation of the product requirements, specifications, design, testing, validation, and changes. Documentation is crucial for ensuring the traceability, consistency, and compliance of the product, as well as facilitating the communication, collaboration, and verification among the product team and stakeholders. To avoid this error, you should follow the GMP documentation best practices, such as using clear and concise language, following standard formats and templates, keeping records up to date and organized, and using electronic systems to store and manage documents.

3 Inadequate testing and validation

A third common GMP product development and design error is not performing sufficient and rigorous testing and validation of the product before launching it to the market. Testing and validation are necessary for verifying the product quality, safety, and efficacy, as well as ensuring the product meets the regulatory requirements and customer expectations. To avoid this error, you should plan and execute a comprehensive testing and validation strategy, covering all aspects of the product performance, functionality, usability, reliability, and stability, and using appropriate methods, tools, and standards.

4 Insufficient change control

A fourth common GMP product development and design error is not implementing a robust and effective change control system to manage any changes or modifications to the product during or after the development and design phases. Change control is important for preventing any unintended or adverse effects of the changes on the product quality, safety, or efficacy, as well as ensuring the changes are documented, authorized, and communicated properly. To avoid this error, you should establish and follow a change control procedure, involving the identification, evaluation, approval, implementation, and verification of the changes, and updating the relevant documents and records accordingly.

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?