Validating cleaning procedures in biopharmaceutical manufacturing facilities Cam to cam chating girls with smoking drinking

06-Jun-2017 17:47

Implementing continuous process improvements is increasing in priority for the biopharmaceutical industry.Such implementation can be driven by product safety, purity, and stability enhancement opportunities as well as by cost-reduction pressures.Our approach aligns with the US Food and Drug Administration’s (FDA’s) product life-cycle concept (6) and the expectations of “prospective” validation (based on a preplanned protocol).The study plan should specify criteria for concluding whether a process consistently makes acceptable quality product as well as provisions for addressing deviations from expected results and handling nonconforming data.

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A similar approach is needed for all unit operations, however, to allow product-quality verification — an essential aspect of qualification and process validation.Examples include growth medium optimization, purification column operation optimization, and enhanced recovery during final filling (2).Continuous improvement and innovation projects often call for changes to licensed processes that require validation, but not necessarily animal or clinical studies.For example, virus-clearance studies in accordance with ICH-Q5A (5, 6) are performed using scale-down purification systems because it does not make sense to spike live virus into a unit located in a CGMP commercial manufacturing area. More recent guidance permits the use of commercially representative “laboratory or pilot-scale models” to estimate variability (6).

We reasoned that the concept could be extended to include cell-culture/scale-down bioreactor systems in support of validation of process changes, so we provide here a “road map” to that end.In accordance with GMP principles, process validation can be summarized as the collective activities “establishing scientific evidence that a process is capable of consistently delivering quality products” (6).The goal of qualification (in the context of our discussion) is to confirm that components of a process — the scale-down bioreactor in this case — represent their production-scale counterparts and mimic their performance (within and/or beyond normal operation ranges, as discussed below).The terms qualification and validation have specific definitions based on the context of the activities they encompass (as the “Definitions” box describes).