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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 3
First page : ( 1511) Last page : ( 1516)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00275.9

Regulatory Challenges of Sterile Formulation Development As Per USFDA Prospectives

Satheesh S*, Abimanyu S, Kamaraj R.

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: satheeshsatz445@gmail.com

Online published on 22 April, 2020.


For the sterile product development FDA has taken many initiatives for the safety and efficacious products. Recently, many works have been done for the improvement in drug development. Quality by Design (QBD) Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. In this review, we discussed an overview of regulatory challenges to improve the quality aspects for sterile drugs. FDA has regulated current good manufacturing practice (CGMP) regulations for the manufacture of large volume parenterals. The studies can then be prolonged to multiple ingredients to assure compatibility with the API and each of the excipients. The compatibility of the drug product should provide appropriate information about the drug product. It should deals with the quality of drug product and route of administration for the intended use. Microbiological review conducted in 1970–1971 for the manufacture of sterile drug was one of FDA's responses to the nosocomial bacteremias, Recently the new drug microbiology review function has been re-examining its role in non-sterile dosage forms in order to Know about recalls and adverse event for oral and topical drug products. For the Active pharmaceutical ingredient justifying the quality source is generally time-consuming effort whether the product is manufacturein-house, as with an Non chemical entity, or sourced externally, as with a generic API.5



Sterile formulation, Active pharmaceutical ingredient, Compatibility, drug product, Recipients.


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