Paolo Alzalamira
R&D and Technical Manager at Dos&Donts

Developing software that complies with Good Manufacturing Practice (#GMP) regulations can be a complex and challenging process. The Good Automated Manufacturing Practice (#GAMP) approach, which emphasizes Risk-Based Thinking (RBT), can help ensure that software is developed in a way that meets the necessary quality requirements.

What is GAMP?

GAMP is a set of guidelines developed by the International Society for Pharmaceutical Engineering (ISPE) that provides a framework for developing and maintaining computerized systems used in pharmaceutical manufacturing. The guidelines aim to ensure that computerized systems are developed and maintained in a manner that meets regulatory requirements and industry standards.

What is RBT?

#RBT is a process that involves identifying potential risks associated with a system, and then implementing measures to mitigate or eliminate those risks. In the context of software development, RBT involves identifying potential risks associated with the software, and then implementing measures to ensure that the software is developed in a way that addresses those risks.

The GAMP Approach

The GAMP approach is based on the idea that the level of validation required for a computerized system should be based on the level of risk associated with the system. The approach includes a number of different stages, including

1. 1. Define the User Requirements
2. 2. The first step in the GAMP approach is to define the user requirements for the system. This involves identifying the needs of the users of the system, and specifying the functionality that the system should provide
3. 3. Conduct a Risk Assessment
4. 4. The next step is to conduct a risk assessment to identify potential risks associated with the system. This involves identifying the potential consequences of the system failing, and the likelihood of those consequences occurring.
5. 5. Define the Design Specification
6. 6. Once the user requirements and risk assessment have been completed, the design specification for the system can be defined. This involves specifying the technical requirements for the system, including the hardware, software, and interfaces that will be used.
7. 7. Develop and Test the System
8. 8. The next step is to develop and test the system. This involves writing the software code, configuring the hardware, and testing the system to ensure that it meets the user requirements and design specification.
9. 9. Validate the System
10. 10. The final step is to validate the system to ensure that it meets the necessary quality requirements. This involves testing the system in a real-world environment to ensure that it functions correctly and that it meets the user requirements

The Benefits of the GAMP Approach

The GAMP approach offers a number of benefits over other software development approaches. Some of the key benefits include:

1. 1. Compliance with Regulatory Requirements
2. 2. By following the GAMP guidelines, software developers can ensure that their software complies with regulatory requirements, such as the requirements set out by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA)
3. 3. Improved Quality and Safety
4. 4. The GAMP approach ensures that software is developed in a way that addresses potential risks and ensures that the software meets the necessary quality requirements. This can improve the safety and efficacy of pharmaceutical products.
5. 5. Reduced Costs and Time-to-Market
6. 6. By using the GAMP approach, software developers can reduce the costs and time-to-market associated with software development. This is because the approach ensures that software is developed in a way that meets the necessary quality requirements, reducing the need for rework and delays.

Developing software that complies with GMP regulations can be a challenging process. However, by using the GAMP approach and incorporating RBT, software developers can ensure that their software meets the necessary quality requirements and is developed in a way that addresses potential risks. This can improve the safety and efficacy of pharmaceutical products, while also reducing costs and time-to-market.