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Sampling
Published in John V. Twork, Alexander M. Yacynych, Sensors in Bioprocess Control, 2020
Although the CGMPs vary from country to country regarding application to genetically engineered processes, it is concluded that the industry application of CGMP guidelines is growing steadily. One factor influencing this conformance is the increasing compliance enforcement by regulating agencies such as the FDA and USDA. As new processes are advanced from the laboratory to the commercial plant, it becomes important that process procedures and equipment be validated at all stages of development. As equipment scale-up progresses, the sampling methods also change as the reactor batch size increases from a few milliliters to over a thousand liters. This requires full coordination between the molecular biologist, genetic engineer, and plant engineer so that the process and its sampling methods are fully validated and the equipment qualified for repeatability and accuracy.
Status and Applicability of U.S. Regulations
Published in Graham P. Bunn, Good Manufacturing Practices for Pharmaceuticals, 2019
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.
Biomanufacture
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
The plan also considers manufacturing compliance as product moves through subsequent phases of manufacture and greater numbers of subjects are exposed to a product. Now, cGMP application has broadened and has become increasingly stringent for each stage of biomanufacture. There is a heightened level of importance and need for cGMP in certain processes such as aseptic technique or sterile fill, because these processes are critical to ensure product safety. With respect to sterility and several other manufacturing controls, there is a single interpretation of cGMP and it applies from Phase 1, or early phase biomanufacture, to commercial manufacture. Yet, less risky processes have little impact on safety and thus are of lesser concern. Therefore, the concept of cGMP application is considered a gradient, beginning with cGMP at Phase 1 biomanufacturing and increasing through commercial production and weighing the risk of a practice or material at every phase. The cGMP regulations are outlined in Chapter 4. Specific examples of quality criteria and application of cGMP are provided in subsequent discussions of biotechnology products and biomanufacturing technologies in this chapter.
What does return on investment (ROI) mean to the pharmaceutical/biotechnology industry?
Published in Theoretical Issues in Ergonomics Science, 2019
Lauren R. Schoukroun-Barnes, Pamela Duchars, Matthew Bartolowits, Kristi Sarno
All R&D costs are included in the investment cost portion of the ROI calculation. Typical R&D includes the initial non-GMP (good manufacturing practices) manufacturing of the product, preclinical testing, initial analytical testing, the GMP manufacturing of the clinical trial material, clinical trial costs and any other costs associated with those activities. The preclinical costs include animal testing, such as immunogenicity, challenge, efficacy, mechanism of action and toxicology studies. After calculating the initial preclinical studies, manufacturing costs are determined, such as quality assurance (QA), quality control (QC), formulation and product and process development. Manufacturing validation, release testing and ongoing stability testing are also factors to consider. QA, QC and release and stability testing may also be considered aspects of regulatory costs because they ensure the product meets specifications. However, it is important not to include the same costs twice (e.g. under manufacturing and regulatory). Manufacturing may also include internal mock audits to ensure the facility manufactures product per cGMP (current good manufacturing practices) regulations, which are typically conducted prior to the manufacture of clinical trial material. In addition to manufacturing and preclinical costs, the clinical costs include site selection, management of SAE (serious adverse event) monitoring and all the additional costs for clinical testing from Phase 1 to Phase 3.