GAMP 5

GAMP stands for Good Automated Manufacturing Practices. This risk-based approach to compliant GxP computerized systems offers a framework for validating computer systems, in which a system is assessed and classified according to its complexity and intended use. Organizing the system into categories aids in guiding the creation of system documentation, including specifications, test scripts, and everything in between.

History

ISPE (International Society for Pharmaceutical Engineering) has published a series of good practice guides for the Life Sciences on several topics involved in drug manufacturing. The most well-known is the GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture. GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving US Food and Drug Administration (FDA) expectations for Good Manufacturing Practices (GMP) compliance of manufacturing and related systems. GAMP 5 was developed by the ISPE GAMP Community of Practice (CoP), a global group of practitioners and subject-matter experts, with significant input and review from international regulators. In 2017, CoP leadership began a formal review of GAMP 5 to determine whether it still met its objectives and to focus its efforts on areas where there is most need and benefit. As a result, the latest GAMP 5 second edition was published in 2022 to accommodate the upcoming development and quality assurance challenges of new-age technologies.

GAMP 5 V-Model

GAMP 5’s approach can be summed up by the V-model diagram. The V-model compares the system specifications created with the testing carried out during the verification process. A system’s level of complexity is related to the types of specifications that are associated with it. For instance, requirements, functional, and configuration testing is carried out for a configured product to confirm the requirements, functional, and configuration specifications. When using commercial off-the-shelf software, functional and configuration specifications are not necessary. As a result, the test scope would also be reduced.

To prove that the system works as intended, verifications are carried out. This is achieved by using the specifications and requirements as an impartial standard against which to evaluate the system. The requirements and specifications that the test scripts verify can be traced back to them. If the test is successful, the test script provides written proof that the corresponding requirements and specifications were satisfied.

However, a V-model-based strategy or a waterfall-model-based approach to the project stage is a ‘Linear Approach’, which may not be suitable in agile environment. Therefore, the latest second edition of GAMP 5 also mentions an ‘Agile Approach’for fast-tracked development.

Principles of GAMP 5

1. Scalable Lifecycle Activities:Pharmaceutical firms have the ability to scale their validation and other lifecycle activities. While many criteria are considered in this activity, some of the most important ones include the system’s impact on patient safety, data integrity, product quality, and more.
2. Leveraging Supplier Involvement: Suppliers are the primary link in the system cycle’s initialization since their quality is the primary determinant of overall performance. To improve the lifecycle, it is therefore standard practice in GAMP 5 to involve the suppliers as much as possible. You can choose how to duplicate papers using supplier documentation to the fullest advantage. It is the exclusive responsibility of regulatory organizations to make sure that the supplier operates effectively to complete this cycle and guarantee high-quality products.
3. Life Approach within the QMS: The entire lifecycle is managed in accordance with the quality management system (QMS). Concept, Project, Operation, and Retirement are the four phases that make up this distribution.
4. Product and Process Understanding: To ensure that product quality is consistently improved throughout its lifecycle, it is essential to have a solid grasp of both the product and the process. This idea primarily focuses on patient safety, product quality, and data integrity.

Categories of GAMP 5

Category 1 - Infrastructure Software

The operating system on which the application software runs is the simplest sort of infrastructure software. Additional software for managing the process control system’s infrastructure consists of operating systems, antivirus software, active directory, database software, server and network hardware, virtual environments, and firewalls.

Category 2 - Firmware

This category has been removed from GAMP and is no longer relevant.

Category 3 - Non-configured Software

Non-configurable software is software that cannot be customized; it is either freely available on the market or is built into the hardware to function. Examples include spreadsheets used as databases or as documents without some level of configuration, data-collecting software without configuration capabilities, control panel viewers, and tools for statistical calculation.

Category 4 - Configured Software

Applications of software that have been specifically tailored to fit the needs of a process control system are known as configured software. Configured software might be as simple as configuring the graphics in a SCADA system or as sophisticated as managing several processes inside a DCS or PLC (linking standard library objects to control the process). These are some instances of process control system software that is configurable such as DCS/SCADA Mimics, DCS/SCADA Databases, and PLC/DCS programs configured from a standard functions library.

Category 5 - Custom Software

Custom software is written from scratch to fulfill a specific business need. The risk of errors in the application code is larger because this program is going through a full development lifecycle. In terms of a process control system, GAMP 5 software can include both custom SCADA/DCS scripts and PLC logic (e.g., Ladder, Sequence Flow Chart, C++).

Importance of GAMP5

GAMP 5 focuses on computerized systems that have the largest effect on data integrity, product quality, and patient safety.

Conclusion

It’s important to recognize that adhering to GAMP 5 will:

1. Greatly reduce risk in your processes and products,
2. Take advantage of (new) market opportunities and expand your market share,
3. Improve your customers’ satisfaction, and
4. Increase the probability of trouble-free FDA audits.