Biomedical Engineering Reference
In-Depth Information
The management of risk to product quality can be used to help companies
effectively plan, prioritize, and perform facility and equipment qualification stud-
ies. Risk assessment techniques can provide the information needed to make
decisions related to the following:
• which systems and components need to be qualified;
• the level to which this qualification needs to be performed;
• prioritization of the efforts needed to qualify these systems;
• determination of the appropriateness of information sources such as commis-
sioning, FAT (factory acceptance tests), and vendor-provided test data and
the extent to which this information needs to be independently confirmed;
• development of the acceptance criteria for qualification studies;
• addressing failures, discrepancies, and deviations uncovered during the exe-
cution of the qualification studies; and
• the extent, frequency, and criteria for repeating qualification studies.
Risk assessments should be used to help make sound and logical qualification-
related decisions. Risk assessments should not make the decision. They should
provide the information needed to make the decision . The key to an effective
qualification program is to understand the relationship between the function of
the facility/equipment and product quality. The risk to product quality and patient
safety should be considered when making decisions related to the planning and
performance of qualification studies.
7.1.1 Qualification, Risk, and Regulatory Expectations
Governmental regulatory agencies require companies marketing healthcare prod-
ucts to provide an assurance that the products are safe and effective. The US
FDA (Food and Drug Administration) states in Part 21 CFR 211.100 of the Cur-
rent Good Manufacturing Practice regulations that companies must have process
controls designed to assure the products possess the defined critical attributes of
strength, quality, identity, and purity [1]. Therefore, companies that manufacture
and distribute regulated healthcare products have an obligation to meet these
requirements and to provide safe products that meet the claims of effectiveness.
Assurance of product quality and process reliability is a regulatory requirement
as well as a sound business practice.
Reinforcing this requirement, in January 2011, the FDA published a revision
of its 1987 Guidance for Industry on process validation (PV): General Principles
and Practices [2]. The guidance presents a three-stage approach to the validation
of processes used to manufacture pharmaceutical and biopharmaceutical products.
• Stage 1-Process design: The commercial process is defined during this stage
based on knowledge gained through development and scale-up activities.
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