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By Brian Chviruk, Bristol-Myers Squibb
The Factory Acceptance Test (FAT) represents a lingering dilemma for many engineers: Accept the vendor’s standard FAT with the intent to recheck everything during the Site Acceptance Test (SAT); develop specialized FAT procedures intended to help reduce SAT activities; or choose one of any number of other options.
When Bristol-Myers Squibb (BMS) announced plans to construct a biologics manufacturing facility in Devens, Mass., it provided a unique opportunity for BMS engineers to put into practice some intriguing ideas they had been discussing about streamlining the entire validation process by incorporating FAT activities. A central enabler included in these discussions was the early incorporation of a manufacturing execution system (MES) into the work process.
“Validation” has many different meanings depending on the industry sector. For example, many people associate validation activities with a strict set of requirements established by the U.S. Food and Drug Administration (FDA) that apply only to the drug and health-care industry. Though those in particular industries are quite familiar with FDA validation requirements and activities, the fact is that various forms of validation exist in all industries, albeit frequently referred to by other names – “commissioning,” “verification” and “ISO 9000-certified” being among the more familiar.
Validation is closely related to quality-release testing, but is different in the sense that the latter often implies post-production verification that the product meets pre-defined specification, whereas prospective validation activities prove that the process itself produces products within specification.
Validation also dictates that a robust quality assurance plan exists, is being appropriately applied and, therefore, proves (validates) that the process will produce products within pre-defined specifications.
The significant requirements of any quality assurance (validation) effort include:
Once a process is running and making quality product, engineers are often reluctant to introduce new ideas, technologies or practices because of misconceptions about regulatory hurdles and/or perceived inconsistencies between systems or sites. What is odd is that those same persons often take pride in constantly refreshing their knowledge about technological advances while remaining guarded about being an early adopter.
While a cautious approach intended to protect consumers and patients is critical, today’s worldwide business environment also punishes those that procrastinate in their adoption of innovative technologies and business practices.
What we often witness is that 21st -century business successes come to those companies with a corporate culture that embraces innovative thinking. However, innovative ideas alone aren’t the whole answer. Each idea must be submitted to the securitization of reliable, risk-based management practices that can transition innovative ideas into well-organized, actionable opportunities.
Shortly after the FDA began encouraging the use of risk-based approaches to advance good manufacturing practices, BMS engineers began exploring ways to increase the use of state-of-the-art technologies and practices. Although several innovations have been successfully completed, many of the more novel and forward thinking ideas simply weren’t feasible to implement on existing processes.
When BMS announced plans to build a large-Scale cell culture (LSCC) facility in Devens, Mass., a once-in-an-engineer’s-career opportunity emerged. Employees would have the opportunity to implement an often-discussed, highly integrated, paperless plant designed to achieve:
As previously mentioned, the key to turning innovative thinking into actionable opportunities is the use of sound, risk-based management practices. In the case of BMS’s LSCC facility, risk management considerations included using existing industry consensus standards such as ASTM E2500, ISA88 and ISA95.
The National Technology Transfer and Advancement Act of 1995 requires federal agencies (i.e., EPA, FDA, OSHA, etc.) to recognize existing consensus standards where available and applicable. That means that all government agencies have been instructed to accept the premise of consensus standards and abide by their requirements.
ASTM E2500 describes a science and risk-based evaluation process that is designed to improve how equipment capabilities and performance are validated. The standard achieves its objective by using quality management principles throughout the system life cycle. This approach required incorporating information developed by business owners during the conceptual phase, by the engineering and the equipment supplier during the design phase, and continues through start-up and operation.