‘Quality by design’ is a central principle of GAMP and advocates that quality is built into each stage of the manufacturing process. All aspects of production from the raw materials, facility and equipment to the training and hygiene of staff are covered by GAMP recommendations.

GAMP is a Guideline Not a Regulation.

When GAMP is adhered to, clients in the medical device, pharmaceutical and life sciences industries are assured that their machines are designed and built under a Total Quality Management System. It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a User Requirements Specification for the machine, from which a Functional Requirement and a Design Specification are created. These documents then form the basis for the traceability matrix and for the formal testing of Internal Acceptance, Factory Acceptance, and Site Acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.

The following are the Process Control Systems GAMP 5 Software Categories:

Note: In GAMP 4 there were five software categories these were revised in GAMP 5 to four categories.

• GAMP Software Category 1 – Infrastructure Software– unless a very simple control system (PLC and HMI) there is likely to be some elements of infrastucture software. Infrastructure software in its most simple form is the operating system on which the application software resides. Infrastructure is qualified but not validated. The validation is performed on the hosted application not on the infrastructure.

• GAMP Software Category 3 – Non Configurable Software Configuration- There is no fixed rule as to the validation approach for GAMP Category 3 systems. Non Configurable Software is sometimes called COTS (Commercial-Off-The-Shelf-Software) or just OTS (Off-The-Shelf-Software). The software is capable of operating and automating the business process without any modification. An example of a GAMP category 3 system that is provided with computerised controllers, would be Programmable Logic Controllers (PLC’s) where the application cannot be changed although it may be parameterised to meet the business need. This category also covers cases where a configurable software product is being used but only with the default configuration.

• GAMP Software Category 4 – Configurable Software– GAMP Category 4 software is software applications that are configured to meet user specific business needs. This is possibly the biggest and most complex category. The functionality of the software can be configured to return different outputs depending on the configuration. As a result of this GAMP Category 4 software can require a much higher level of validation than GAMP Category 3.

• GAMP Software Category 5 – Bespoke software is software that is generally written from scratch to fulfil the business need. This software could be written in-house and is possibly the highest risk of the software categories as it is customised and there is a higher level risk of errors within the application code.

The GAMP Software categories can be open to interpretation. Oftentimes there can be some ambiguity as to which category a software application falls under. As a result of this too much or too little validation effort may be executed. For this reason the validation effort should be based on the risk impact/assessment as well as taking into account the above guidelines.

Risk Assessment is used to identify, evaluate, control and review the risks. It is then used to determine if validation is required and how much validation is required based on the the level of risk and system impact.

Why your Validation Engineers should work within GAMP Guidelines

As GAMP is a guideline and not an industry regulation it is important to ensure that your validation engineers are up to date with the latest revisions and working to the highest industry standards available. An engineer who takes a measured approach is also required when undertaking the risk assessment to avoid completing too much or too little validation on each project.

 This is where the experience and reputation of your validation engineers count.

The Dataworks team of validation engineer’s work with GAMP 5 guidelines. They have extensive experience operating in the life sciences sector validating software systems and automation to FDA Standards - you can be assured that your software and equipment will be validated to the highest industry standards by our skilled engineers.

 Our team of experienced engineers can help you to enable greater efficiencies, improved quality and compliancy within your industry.

If you would like to discuss how we can help you with your validation needs please call us today on 051 878555 or email us at info@dataworks.ie