Quality and manufacturing organizations in Life Science companies are facing more pressure than ever to operate efficient, uninterrupted production at the lowest possible costs, while meeting ever more stringent safety, quality and regulatory standards.
To keep costs low, many firms are externalizing portions of their supply chains and operations and have a greater need to tightly integrate their business processes with these external partners and service providers - contract manufacturers or CMOs and labs - and ensure regulatory compliance. Production interruptions can waste millions of dollars per day, while consent decree fines for Good Manufacturing Practice (GMPs) violations can be exorbitant.
At the nucleus of these regularly competing priorities for today’s Life Science organizations is the need to maintain the plethora of documents to prove GMP compliance throughout the product lifecycle.
What is the DIA GMP Quality Systems Reference Model?
The Drug Information Association (DIA) GMP model provides a reference for the documents (artifacts) and metadata that are typically needed to implement leading practice solutions and business processes for managing the GMP Quality Systems documentation required for regulatory compliance at biopharmaceutical companies.
It is a reference for the Life Science industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry for greater interoperability and simplified business process hand-offs among sponsors, business partners, suppliers and service providers related to GMP documents and content required for compliance.
How Can the GMP Model Help You?
- Simplify Interactions with External Organizations: If you and your business partners use the model, it will be easier for you to integrate your document management processes and systems to ensure that your entire supply chain ecosystem remains compliant. As companies become more externalized, standardization has been a significant trend to enhance interoperability.
- Enhance Compliance: The GMP model can be used as a resource to assess whether you have all the documents you need to prove compliance; therefore, companies can reduce risk by comparing what they have in their systems and paper files to the model.
- Facilitate Consolidation due to Mergers and Acquisitions: The model provides a great “neutral ground” for organizations to leverage as they consolidate their processes and systems after a merger. In essence, it can help you avoid political issues that can occur if the acquired company is forced to move to the parent company’s processes and systems.
- Streamline New System Implementations: Growing firms seeking to implement a new system to manage their GMP compliance documents will be able to more quickly stand-up leading vendor solutions that include the GMP model by adopting the information architecture out-of-the-box as much as possible. Additionally, these firms will need to manage fewer company-specific configurations over time and have an easier upgrade process.
The GMP Quality Systems Reference Model team has done a great job to bring a structured organization of content to GMP compliance documentation. By having a large number of participants - Sponsors, Vendors, Consulting Firms - the Reference Model Team has been able to ensure that the GMP content structure satisfies general industry needs. The GMP model is in the midst of final DIA review before it is posted publicly on the DIA website; however, the model can be downloaded here for early adopters to use.
What's Your Next Step? Work with an experienced partner to help you define a future vision and strategy for managing your GMP compliance documents and a plan to achieve the vision.