Formulation Development Studies for Sterile Dosages: A Comprehensive Review
Sterile generic dosage development requires that specific critical quality attributes be considered and evaluated, regardless of the route of delivery or the type of registration application. The review briefed with an overview of Pharmaceutical Development study requirements. Each of the various stages of studies like Compatibility with the packaging materials, manufacturing vessels, processing aids, MOCs, Filters, Tubing’s and Gaskets also with special studies to be conducted as part of Regulatory Submission, process considerations. Thus, the chapter offers the formulator an overview of the foundational principles associated with formulation development /Pre-formulation studies of sterile products.
Keywords: Pharmaceutical Development, Compatibility, Studies, Hold time.
2. USP General Chapters on Elastomeric Closure for Injections <381>.
3. USP General Chapters on Biological Reactivity Tests – In Vitro<87>.
4. ICH Q1B; Photostability Testing of New Active Substances and Medicinal Products CPMP/ICH/279/95; January 1998.
5. PDA Technical Report No. 39, Revised 2007, (TR 39) ; Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment.
6. USP General Chapters on Pharmaceutical dosage forms <1151>
7. USP General Chapters on Container content for injections <697>
8. Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; FDA/CDER Guidance for Industry Pharmaceutical Quality/CMC; June 2015.
9. USP General Chapters on Elemental Impurities –Limits <232>.
10. ICH Harmonised Guideline for Elemental Impurities Q3D final version ; 22 March 2019.
11. USP General Chapters on Extractables and Leachables: <1663>, <1664>.
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