The Impact of Validation Programs on Consumer Safety

Failure to comply with current good manufacturing practice (cGMP) could lead to recall, seizure, fines, and even jail time. For pharmaceutical companies, a misstep in cGMP could be the difference between life and death.?

Keeping people safe is a top priority for Fluor, and we build specific checks and balances directly into project execution for GMP-regulated facilities.

Various global regulatory agencies, such as the U.S.-based Food and Drug Administration and the European Medicines Agency, dictate that all systems affecting the final quality of a product – from in-process materials to finished goods – are subject to cGMP. Adhering to these regulations requires the utmost precision.

Regulators mandate that project execution teams create validation master plans (VMP) during the conceptual stage and carry them through construction. These documents not only include the scope of work, but also all planned validation activities. Teams regularly consult VMPs throughout the construction process to seek information regarding analysis, supervision and change management systems. Without it, companies would not have the documentation needed to pass inspection and testing.

Regulators also mandate that a quality risk management (QRM) plan is in place to evaluate risk to quality based on scientific knowledge, experience with the process and ultimately the protection of the patient. The QRM identifies how potential failures affect the product quality and patient safety, and activities that minimize the risk of failure. Execution teams utilize the QRM to examine failure mode, effects analysis, system user requirements and more. QRMs are fully customizable and can be used to optimize the validation process.

Fluor’s validation program includes the activities and documentation required to adhere to cGMP rules across all project phases. We integrate validation into all systems related to product quality, from design to installation and testing. We have found that the most efficient way to integrate our quality validation program is to execute it in four phases.

Phase one, quality planning and risk assessment, takes place during conceptual design. Next, Fluor’s validation team analyzes the design against user or client requirements found in the validation master plan. If the products and processes pass the analytics phase, then the team continues with testing. Only after achieving repeated positive results will the validation team move toward the final phase, when the team collects data from all previous phases and reports on the results.

Not only must the products and processes meet the specifications, but the reported findings must reflect the actual outcome of the testing phases. In other words, accuracy is critical. Fluor provides these findings to clients so that the process is continued throughout production well after initial construction and execution.

Our fit-for-purpose cGMP compliance solutions align with our Core Values of safety and excellence. Patient health is a top priority, and stringent validation is one of many avenues for keeping consumers safe. Learn more about our validation program and the full scope of services we provide to the life sciences industry.

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References

EudraLex – Volume 4 - Good Manufacturing practice (GMP) guidelines.

International Conference on Harmonization, Quality Documents.

ICH Q9: "Quality Risk Management"

ISPE Baseline Guide vol. 5 Commissioning and Qualification (June 2019)

EU GMP vol.4, part III, Annex 15