What is ACMS? Why was it developed? And how is it advantageous in the continuous improvement of single-use supply chain management?
It goes without saying that assuring quality is a primary responsibility of all parties in the biopharmaceutical supply chain. Drug manufacturers, ancillary material producers, and equipment suppliers must work in harmony to deliver high-quality, safe, and efficacious products to market.
Drug manufacturers and their suppliers should have easy-to-use quality management systems in place, working to create a culture driven by quality. Data should go beyond regulatory compliance requirements to include documentation confirming that all components and methods used in drug manufacturing—as well as the controls used to ensure process and product quality—are appropriate and adequate to preserve drug composition, quality, and purity.
Why was our Advanced Central Management System (ACMS) developed?
Nearly ten years ago we dedicated resources to developing a documentation approach with the aim of supporting and optimizing the end-user/customer experience with our portfolio of single-use systems and associated components. This allowed us to design a complete web portal where biomanufacturers can access information such as manufacturing quality documents, product quality certificates, single-use system (SUS) design manifold drawings, extractables and leachables (E&L) data, packaging/transport validation, compliance statements, material safety claims, and performance data. The Advanced Central Management System was the result of this targeted area of work.
What is ACMS?
It is a dynamic system to support an internal quality-by-design approach to the development of single-use assemblies, from the initiation of projects through to design and implementation. The ACMS acts as a repository for all Cytiva SUS designs, component information and junction testing, with various levels of data available to users. For all Allegro™ SUS, the ACMS ensures that components (and their suppliers) are fully approved, and all joints are secure and fully validated. It also assures that the final assembled, packaged, and where-specified, system with a sterile claim, is suited to its application and adequately documented.
Looking into the ACMS Modules
Within the ACMS system, components are listed and cross-referenced by part number, supplier, picture, drawing, component type (e.g., tubing, filter, biocontainers), a standardized component type description and preference status. It comprises of several different modules including the Primary Parts Module, in which components are clearly indicated as preferred (stocked), non-preferred (not stocked), or restricted. These preference categories are defined by strict component selection criteria, including supplier approval, component approval (validation data), component rating and joint combination testing.
This also helps to drive rationalization through preferred components usage. Preferred status drives users to the highest level of quality, including all appropriate documentation, with stocking of preferred components helping to reduce system lead times.
Individual component quality controls and documentation
The ACMS was designed for biomanufacturers, and us as a supplier, to work in compliance with current Good Manufacturing Practice (cGMP) requirements and conform to 21 CFR Part 11. As such a full audit trail is maintained for each system access and change. Strict procedures have been established for the addition of new components to ACMS with component records being created by engineering users then submitted for quality/engineering approval. If rejected for any reason, the engineering users must address the shortcomings and resubmit the component and its record for quality review. Once the new component has quality approval, the record for the new component can be released in the ACMS.
Digitizing documentation for easy access
The Accelerator Documentation Center serves as a central web accessible platform for 24/7, easy access to comprehensive information on single-use components and technologies, ensuring product compliance and supporting regulatory activities. The Accelerator Regulatory Dossier is included in the Accelerator Documentation Center and is linked with the ACMS to create a crossflow of quality single-use component and assembly documentation for regulatory submissions, with many of the documents being generated using data stored in the ACMS.
The Accelerator Documentation Center houses product compliance, regulatory, general product and quality documentation, as well as information provided by our subject matter experts. This includes webinars, white papers, industry group reports, and more, providing resources to meet end-user/customer needs. There is also a mechanism for filing product complaints and accessing Product Batch Certificates.
Access to the most up-to-date information in an auditable and traceable format helps to save time and resources for the entire SUS lifecycle.
Items Included in the Accelerator Regulatory Dossier
- Quality management certificates
- Manufacturing flow charts
- Product validation and qualification
- Performance validation
- Material compliance
- Product specifications
- Shelf-life data
- Sterilization validation
- E&L reports
- Other compliance data
ACMS and industry collaboration/standardization
Clearly the ACMS has been designed to reduce and manage the complexity of a single-use supply chain and accelerate development of bespoke and standard, end-user specific products and solutions. However, much of its inherent advantage is its alignment with BioPhorum’s 5-year single-use-technology (SUT) plan. Much of industry best practices and standardization in response to single-use supply chain challenges have been brought about through collaboration of biomanufacturers and suppliers, led by community interest groups like BioPhorum and Bio-Process Systems Alliance (BPSA). So, although ACMS began its development prior to BioPhorum’s five-year plan, the nature of its development has been such that it aligns with industry solutions to SUT supply chain challenges.
Today, the ACMS is a fully validated solution to support a QbD approach to single-use assembly design and production, ensuring the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages. ACMS has become a distinct asset in the continuous improvement of the single-use supply chain.