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Is your single-use system supplier disposable? As disposables become more commonplace an effective Quality Management System can differentiate suppliers.

During the last six years, single-use systems and devices have emerged as key agents in the biopharmaceutical landscape. 1 Single use solutions have revolutionized the pharmaceutical and biopharmaceutical industry due to their effectiveness in reducing the risks of contamination and allowing faster change-overs. These advantages, coupled with the significantly reduced time and costs required to establish a new manufacturing facility, have made single-use systems the products of the future.


Single-use products have pushed beyond an early-stage technology, and it is likely that the popularity of these devices will continue to rise over the next few years.1 Therefore, it is becoming increasingly important to view single-use system suppliers, not only in the context of 'can they make the disposable," but also from the perspective of 'does the single-use system supplier maintain strong quality oversight to support their product from a control process and ensure regulatory compliance.' The recent 9th Annual Report and Survey of Biopharmaceutical Manufacturers2 indicates that endusers of single-use devices rate product quality at the top of their supplier attributes list. The manufacture of high-quality devices requires single-use system suppliers to minimize risk and ensure safety, traceability, and compliance at every stage of production. To minimize risk, single-use system suppliers must control and document each production step from raw materials and assembly to final test, packaging, and sterilization.

As a result, change control has become an important factor for the biopharmaceutical industry. Indeed, the FDA's guidance for single-use system suppliers clearly reinforces the importance of implementing efficient change control procedures as a critical element in an overall quality system, and suggests the scope of a successful change control program must cover a broad set of possibilities, including changes to the supply chain and product specifications or design, as well as upgrades to facilities, utilities, equipment, computer systems, manufacturing instructions, SOPs, test methods, and any changes in policy.3

Effective change control systems take time to establish and must be continuously updated. A mature change control system becomes intuitive and relevant. Intuitive in that it fosters a structured approach towards managing and documenting change in an environment that engenders continuous improvement, and relevant in that it stays centered on the objective and nature of pending change, and focused on the exact scope of imminent change. 3

The key components of a change control system include3:

* End to end communication with all stakeholders from raw materials vendors to product endusers

* A consistent, structured, and sequential approach towards managing change

* An automated system that provides flags, alerts, the ability to search by a variety of criteria, and requires authorization via user credentials in order to make changes

* Routing of change requests to appropriate individuals for approvals

* Documentation of the details of change, change approvals, and implementation, thereby tracking changes effectively for visibility and traceability

* Easy retrieval of information

* Provision of an audit trail

* Demonstration of compliance to FDA regulations

* Speed, to allow due deadlines to be met

* Education on change control methodology for all employees, to allow timely execution of inventory disposition and existing job orders

Incorporating these key components allows for a dynamic change control system that can help end-users implement continuous improvement and manage impending change. (3)

In particular, a change control system must effectively accommodate supply chain interruptions, as the ability of a single-use system supplier to provide accurate raw materials data is crucial to the quality of high-value products. Raw materials changes are notoriously inconvenient for the end-user, 2 but often unavoidable, and include changes to component specifications, suppliers, and resins utilized. The change control system must accommodate the inevitable and minimize inconvenience to the end-user by streamlining provisions for the tracking, reviewing, and receiving customer approval of raw materials changes. The system must be flexible so as to allow appropriate, rational documentation of change justifications. Furthermore, the system must extend change control to raw materials vendors, so that the change control procedure can be initiated before the processing of any components impacted by the changes.3

As an example of a structured, consistent, yet flexible change control system, ASI has implemented a Quality Management System (QMS) that features a well-defined procedure that involves responsibility and accountability. Change notifications are logged and maintained under the QMS. ASI's Engineering Change Order process identifies the items affected by change and the steps required to control how the changes are executed. Examples of such changes include tooling and equipment changes, bill of material changes, product drawing changes, compliance changes, manufacturing routing changes, raw materials changes, and process changes. A raw Material Review Board, comprised of key decision makers from the Quality Assurance, Engineering, Purchasing and Inventory Control departments within ASI, meet regularly to ensure that the change control system is working effectively and efficiently. All ASI personnel understand the need for and challenges associated with change control. ASI's ERP and QMS are integrated throughout every aspect of the company and accessible throughout the facility.


(1.) Langer E. Single use technologies changing the biomanufacturing landscape. RAPS Advanced eCTD Submissions Workshop 2012

(2.) Langer E. Biopharmas Increasingly Satisfied With Vendors Of Single-Use Products. BiopharmDev&Mfg Industry News 2012

(3.) Change Control in the FDA-regulated Industry.

* By John Briggs ASQ, CQA; ASI Quality Assurance Manager
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Title Annotation:SINGLE USE
Author:Briggs, John
Publication:Pharmaceutical Processing
Date:Sep 1, 2012
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