Biotechnology Pharmaceuticals
Introduction:
Big Horn Safety offers services related to biotechnology or biosafety to companies or individuals. We have biopharmaceutical regulatory and biotechnical expertise that can assist companies to become FDA-compliant and safe.
From FDA’s website the following recommendations are required:
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“Biopharmaceuticals must comply with the same cGMP requirements as chemical pharmaceuticals but since some of them are large protein molecules created by mammalian cells, tests need to be done in order to detect viruses of human or nonhuman primate origin because viral contamination arising from these cells may pose a particular hazard."
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"Many other biopharmaceuticals are produced by fermentation of bacteria such as E. coli and do not have to undergo testing for viruses but production still has to be done under sterile, aseptic processing conditions. A full cGMP inspection of aseptic processing can be performed for compliance with cGMP of sterile products."
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"Validation of the cleaning procedures for the processing equipment, including columns, should be carried out. This is especially critical for a multi-product facility. The manufacturer should have determined the degree of effectiveness of the cleaning procedure for each biotech-derived product or intermediate used in that particular piece of equipment."
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"While these are specific comments from guidance documents, it should be recognized that inspectors may have additional expectations for cleaning validation in biotechnology based on current industry practices and on their past experience with similar companies."
Our team at Big Horn Safety has expertise and experience to help your company be compliant and safe. Contact us for more information or to discuss your needs.
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