Introduction to Validation of Biopharmaceuticals - - BioPharm International


Introduction to Validation of Biopharmaceuticals

BioPharm International

PQ is documented by processing actual feedstock by trained operators using buffers and utilities at the factory. Full-scale process validation includes testing the consistency of batch production.

Software validation operates under the principle that quality should not be diminished if a manual process is replaced with an automated process. Software must be developed and tested under a quality system with defined user requirements, change-control procedures, provisions for authorization of operators for data entry and data checking, data archiving, software backup, provisions for system crashing, and procedures for monitoring and correcting software problems. 21 CFR 11 defines requirements for maintaining the integrity of data and software and handling electronic signatures for traceability.

Cleaning validation demonstrates the ability of cleaning procedures to permit reuse of processing components and equipment without a concomitant deterioration of product quality. Batch-to-batch carryover is of particular concern in multi-use plants making more than one product.

Consistency of product quality is demonstrated by showing operating consistency and product quality from batch-to-batch, processing with only buffer (blank runs) with assays for contaminants, examination of cleaned surfaces and materials, and extended scale-down clearance studies on reused materials. Disposable processing components that eliminate the need for cleaning validation are increasingly used at small scale.

Herb Lutz is strategic marketing manager at Millipore Corporation, 80 Ashby Road, Bedford, MA 01730, 781.533.2366,

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