In the United States, specific regulations for sterile injectable production have not been changed in recent years, but the FDA did modernize its approach to the inspection of sterile injectable manufacturing plants in 2018. The New Inspection Protocol Project (NIPP) was established in November 2018 and uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of findings.[139]
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Given the rapid growth in demand for presentation of sterile injectables as prefilled syringes for administration in both the clinic and home settings, the industry and regulators have been faced with establishing comprehensive testing to ensure the safety and quality of the final products. Both empty and filled syringes must be evaluated to confirm compliance with an extensive array of performance and quality requirements.
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The compliance challenges facing developers of drug–device combination products, such as sterile injectables in prefilled syringes, are only increasing as regulators seek to ensure that supply meets growing demand and quality is maintained. Manufacturers are being expected to more effectively control their production processes and reduce the risk for process variation and contamination.[56] As a result, guidelines and applicable manufacturing standards for drug–device combination products are evolving rapidly.
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The need for rapid development of COVID-19 vaccines led to the development of temporary regulatory guidelines for accelerated manufacturing. Some of these guidelines, such as the FDA’s Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. Guidance for Industry,[143] may be applicable to GMP sterile drug and vaccine manufacturing going forward — obviously for other pandemic situations, but potentially ultimately as general guidances.[144]
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There are different types of facilities that compound final drug products: 503A facilities produce products formulated for individual prescriptions, while 503B facilities manufacture larger batches of drug products for healthcare facilities. The latter outsourcing companies were created in response to drug shortages, and in correlation with the large number of sterile injectables experiencing those shortages, 503B facilities largely produce sterile drug products.[146] These are a relatively new category of facility and often struggle to comply with cGMP regulations.
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