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Every FAT protocol (unit procedure) began with protocol boilerplate―objective, scope and preliminary checks. Then common pre-shipment checks, such as general arrangement and piping and instrumentation diagrams and walk-downs. Other installation checks to ensure proper installation on-site were included (i.e., proper materials of construction, accuracy of dimensional and connection points, component accessibility, spare parts, etc.) The last portions of the BMS electronic FAT protocols included operational checks (i.e., power up, loop check, dry and wet checks, etc.) of system functionality.
Certainly FAT protocols vary between entity classes (i.e., Bioreactors, Centrifuges, CIP skids, Chromatography Skids), but the use of an electronic method for each entity class permitted it to be configured once and then re-used by redefining entity specific parameters at the instance of each test.
For the Devens project, approximately 50% of the electronic FAT protocols became “standard instructions,” meaning they were written to be used over and over. Another 20% were “variable instructions,” meaning each subsequent use required only minimal changes. The remaining 30% were “unique instructions,” required authoring and review times equivalent with a paper-based system.
Based on the time required to prepare paper-based documents for previous projects, and excluding the time required to learn the Syncade system, the use of the Syncade’s Electronic Work Instructions permitted the BMS project team to save more than two hundred man-hours. (See “Bioreactor Document Preparation Efficiencies” table below.)
Though GDP is important for a variety of regulatory reasons (i.e., EPA, OSHA, legal, etc.) in every industry segment, the BMS project team focused its GDP efforts on complying with FDA regulations and guidelines. Nevertheless, it should be understood that proper GDP is proper GDP, regardless of the industry.
GDP is not specifically addressed by the FDA. Instead, GDP repeatedly appears in cGMP (current good manufacturing practice) documentation and can be paraphrased as, “Good documentation practices are the set of activities that enable you to record product-related data, hand-written and/or electronic, in a legible, traceable and reproducible manner.”
When using paper-based documentation, GDP is often one of the most common and time-consuming source of errors. These errors include comment and/or signature blocks that are incomplete or illegible; failure to follow “cross-out” procedures intended to allow others to read what was crossed out; and documents that become illegible because of tears and smudges. And then, of course, there is always the possibility that the paper record is misfiled or becomes completely lost.
For BMS the use of the Syncade and its typical electronic insistence on properly completing forms played a significant role in eliminating the many disadvantages associated with paper-based documentation systems. Additionally, Bristol-Myers Squibb’s MES-based solution was able to make use of pull-down menus for such things as standardized “as found” responses and pre-defined comments. And lastly, the Syncade application was hosted on a secure and routinely backed-up server, thereby eliminating those dreaded misfiled and lost records.
Everyone knows that the job isn’t “done-done” until the paperwork is finished. In the case of FDA regulated products, that means a product can’t be released for shipment until authorized persons have reviewed the production data, operator comments, laboratory results, etc., and reconciled each and every exception. When batch records are paper-based, it means going through every page, deciphering every signature and comment, probably calling a few people for clarification of what they meant, and so forth―a tedious and often time-consuming string of activities.
Contrast that with documentation that is being completed and posted on a server in real time. This documentation is consistent in appearance and content from shift to shift and operator to operator. Also, consider the benefits of having the MES assemble laboratory and manufacturing records in consistently organized batch records with exceptions clearly indicated. The result is that the MES wholly facilitates Bristol-Myers Squibb’s “batch release by exception” goal.
When BMS committed to constructing its Devens, Mass., LCSS biologics manufacturing facility, it also committed to the pursuit of the U.S. Green Building Council’s Leadership in Energy and Environmental Design (LEED) certification, which recognizes site development, water savings, energy efficiency, materials selection and indoor environmental quality.
BMS engineers wholeheartedly embraced the company’s commitments to implement long-discussed plans to create a highly integrated paperless plant. The results include not only electronic production and laboratory batch records supporting exception-based batch releases, but also a streamlined risk-based validation process, all the while supporting the companies Sustainability 2010 Goals through LEED certification at the Deven facility.
In short, success truly is what happens when diligent preparation and excellent execution are applied to an opportunity.
Brian Chviruk is a Validation Engineer at the Bristol-Myers Squibb, Devens, Massachusetts, Large Scale Cell Culture facility
Bristol-Myers Squibb and the entire pharmaceutical industry face many challenges in meeting the needs of patients, health care providers and society at large. The entire industry must intensify its efforts to improve access to medicines and healthcare in general. It needs to encourage innovation, in part by protecting intellectual property. It must operate efficiently and profitably so it can continue to invest in research and development leading to new and better medicines, and it must do all of these things while advancing safety practices and environmental protection.
The Bristol-Myers Squibb Web site (www.bms.com) provides significant details about its Sustainability 2010 Goals including its progress in addressing key areas.