The Processes - - BioPharm International


The Processes

BioPharm International

Regulatory Guidelines

Fermentation and cell culture practices in the biopharmaceutical industry are regulated by the Code of Federal Regulations (CFR), Title 21, Parts 210–211, describing current good manufacturing practices (cGMPs). Also important are 21 CFR 600–680, which talk about biologics specifically. Diagnostics are governed under Part 800, which covers medical devices. In addition to those laws, the FDA has released (through its Center for Biologics Evaluation and Research) many "Points to Consider" documents that detail further guidelines. Although such documents are not regulations that carry the force of law, FDA inspectors certainly expect to see their recommendations followed. When published in the Federal Register, however, guidelines from the International Conference on Harmonization (ICH) do carry the same weight as FDA regulations. Another source of guidance is the United States Pharmacopeia and National Formulary.

Regulations emphasize that biologic products must be produced in properly validated facilities. Validation of processes involves many different protocols. Equipment must be qualified for use. Installation qualification helps technicians determine whether equipment is installed according to requirements. Operational qualification documents the methodologies used to operate and validate each item and record measured information for analysis. Performance qualification ensures that the equipment will do the job it is intended to do. Process validation studies and conformance lots are used to demonstrate process reproducibility. Control qualification checks automation and controls. Standard operating procedures specify how work is done in the fermentation facility, and employees are trained to follow the letter of the law in all matters of research, bioprocessing, documentation, and cleanliness. In addition, regulatory agencies require characterization of all cell lines and cell banks used in producing pharmaceuticals.

Technicians working in bioprocessing plants must wear special clothing and have special training to work there. Such facilities require sophisticated process plants, with all fluid handling in enclosed systems. Process vessels and associated pipework systems must be pressure and integrity tested to ensure that there are no leaks. Stainless steel pressure vessels and pipework are sterilized using clean steam at high pressures and temperatures. All interior surfaces are designed crevice-free with drainage that prevents condensate buildup that can generate possible unsterilized cold spots. Pipework is specially welded and incorporates sanitary valves and pumps. Product contamination (by accumulation of deposits, for example) is prevented by thorough periodic cleaning and sterilizing.

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