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Biotechnology, pharmaceutical, and medical device facilities must comply with the FDA’s current Good Manufacturing Practices (cGMPs). Biotechnology validation ensures that that a facility’s design and operation is in accord with regulatory requirements as documented in GMLs.
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Validation is a dynamic process. It is expected to follow a timeline stretching from initial design through to production. Typical expectations are that design qualification (DQ), installation qualification (IQ), and operational qualification (OQ) should be nearly complete early in the development process, at phase 1 and 2. Process qualification (PQ) should be complete at end of phase 3. But everything evolves with the process, and that process is usually a moving target until registration.
A frequent problem is the failure to address the life cycle of the system as a whole — most biotechnology validation efforts focus on individual subcomponents of the process and stop after the specified number of process runs that are required to gain qualification. For successful biotechnology validation of Processes used in the manufacture of drug products, the regulators expect validation of all manufacturing steps: cleaning, weighing, measuring, mixing, blending, filling,
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