GAMP 5 Updates Address Shift to Digital Solutions and Services
An increasingly digital world provides new possibilities for generating and managing data, but it also carries new challenges in security and compliance. That’s why the 2nd edition of the GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized systems, published earlier this year, addresses the pharma industry’s growing reliance upon electronic production records, digital technologies, and IT services. It provides valuable guidance for ensuring GAMP compliance using secure and up-to-date technology solutions.
In this article, we’ll spotlight a few of the key changes in GAMP 5 around the use of electronic production records, and how pharma companies can better manage supplier activities to remain in compliance with all regulations.
Guidance for moving to electronic production records
Appendix S2 on electronic production records (EPRs), a new addition to GAMP 5, describes state-of-the-art approaches and technologies for the implementation of EPRs to support manufacturing in GxP environments. In addition to its guidance on implementation methods, the appendix lays out the advantages and risks of adopting certain advanced strategies for managing data in EPRs. These include:
- Review by exception (RBE): A strategy for ensuring that data is within record specifications. It leverages the strengths of both human and system-based review operations, for an efficient, risk-based quality review process.
- Real-time disposition: This allows quality activities to take place in real time, in parallel with production’s process of facilitating approvals.
- Cloud solutions: Following a risk-based approach towards cybersecurity and vulnerabilities, these solutions must account for any potential impact on the integrity of underlying data.
- Blockchain: This can provide security for records but is best used for immutable data, such as audit trails and subsets of EPR data.
The importance of tracking how data flows
Besides these technical recommendations, the appendix also emphasizes the importance of understanding the processes and data flows within manufacturing. As in past editions of GAMP 5, it also advises critical thinking when defining critical records.
The guide suggests pharma companies may best enable this understanding by performing regular data integrity assessments as well as Gemba walks within the production environment. These exercises offer numerous benefits, as they can provide a thorough understanding of the risks related to data integrity, identify potential gaps and provide a place from which to determine appropriate remediation actions. Moreover, this can form the basis for a strong quality culture.
Better records begin with stronger supplier relationships
Electronic solutions are becoming a requirement for sound data integrity and records management. However, that makes it critical that pharma companies work with secure IT/IS solution providers. After all, regulated pharma companies shoulder the responsibility for GAMP compliance and the risk of non-compliance.
Vendor management is a critical activity for the pharma industry, but it’s not a requirement that should discourage pharma companies from moving forward with IT/IS investments. Fortunately, the updated GAMP 5 guide provides support for leveraging partnerships with appropriately qualified suppliers. This allows pharma companies to better draw on the knowledge of technology solutions and documentation support that these partners can provide.
Section 7 of the updated GAMP 5 guide highlights the importance of IT/IS services, particularly that of the cloud computing providers rapidly emerging as a central pharma industry supplier. This updated section includes several references to ISPE’s GAMP Good Practice Guide: Enabling Innovation, with its focus on service provision, agile methods, prototyping, and requirement development.
The section on the supplier Quality Management System (QMS) has also been updated. It now provides guidelines around the management of documentation, records, and related information, as well as the management of supplier-related incidents, problems, and nonconformities.
In addition, the updated GAMP 5 encourages suppliers to adapt their process according to their pharma customers’ business needs. This includes a focus on continual improvement through the adoption of current software development models, supporting tools, and automation. It’s not enough for suppliers to present the best product in the market. They must also prove that their product is supported by a compliant QMS that can be leveraged by the pharmaceutical industry without extensive additional risk-reducing activities.
How to select the right partners
The advantages of shifting to electronic data far outweigh the risks for most pharma companies. Knowledgeable suppliers of cloud computing and other technology solutions can help pharma companies navigate many of the challenges around implementing the wide range of products, applications, and IT services available today. Of course, the growing need for outsourcing and the usage of technology suppliers comes with the challenge of effective supplier management by the regulated company.
Fortunately, with clear guidance in the 2nd edition of GAMP 5, manufacturers gain the structure needed to implement appropriate validation strategies, evaluate new electronic solutions, select technology suppliers, and ensure GAMP compliance. For further support, GxP-CC offers advice on data integrity topics, digital compliance, supplier management, and QMS. For support in your compliance initiatives, contact us today.