Introduction to GAMP 5 – A risk-based approach to Compliant GxP Computerized Systems

The pharmaceutical industry is undergoing a major challenge these days due to the impact of COVID. Product quality, patient safety, and data integrity remain the top priority in any pharma company. These aspects play an essential role throughout the product life cycle, from R&D through pre-clinical studies, clinical trials, manufacturing, quality control, logistics, sales, distribution, and subsequently recalling the product from the distribution channel.

Pharma companies focus on a risk-based approach for product and process understanding and believe in the Quality by Design concept. It is imperative to validate every step of a business process under the guidance of subject matter experts. The accuracy, integrity of records, and data play a vital role throughout the product life cycle.

Information technology is playing a very crucial role in automating various business processes in every sector. Since Pharma deals directly with patient safety, it becomes even more critical that every step in the value chain gets recorded appropriately either in an IT System or paper-based system under the company's Quality Management System (QMS). QMS keeps records of every step and process defined within the organization using SOPs and policies and defines a periodic review process for validating different aspects of the (Good Practice) GxP systems.

Since the automation of business processes has become one of the key priorities for any organization, many new IT systems are getting introduced in every department. IT companies are doing lots of research in making the product life cycle efficient and productive. The data needs to be retained in the organization as per the regulatory body's guidelines. The introduction of new applications has increased pressure on IT resources to remain compliant for the entire product life cycle. Multiple IT systems remain engaged in storing valuable data from inception till the delivery of the product. Achieving compliance and fitness for the intended use for all GxP regulated systems is essential.

The IT system needs to be validated as per user requirement specifications. Once it is established, no changes should be made without a change control issued by the Quality Assurance Team. Any change in the IT system needs to be appropriately evaluated. The SME's approval is required to move these changes to the production environment. That's the reason why organizations are using multiple environments for Production, Quality, and Development.

It is vital to implement a robust IT system that caters to all the system life cycle approach as part of a QMS, from concept to retirement. The IT solution should be scalable, easy to manage and facilitate the adaption of a Quality by Design (QbD) approach. In addition, data protection, audit trail compliance, and proper computer system validation of the new system are highly recommended during the entire life cycle.

GAMP (Good Automated Manufacturing Practice) guidelines aim to achieve fitness of the IT System for the intended use. When we say, "intended use," it means that the IT system is being used for the purpose for which it was installed. All the compliances related to that system are done by the relevant stakeholders and owner of the application. The various types of validation documents are prepared when a system is validated, and GAMP5 provides guidelines related to the compliance which are accepted by the regulatory bodies.