Venkata Narayana T

WORK HISTORY

EDUCATION

ABOUT VENKATA NARAYANA T

Formulation scientist working in the Topical dosage forms industry for US and Europe markets. Design and development of 505b2 topical and vaginal products. • Conducting literature searches, patent searches, and journal reviews, as well as preparing the presentation for the literature review. • Preformulation studies • Fabrication of lab scale batches, Characterization of physical parameters, and packaging material characterization for Topical formulations. • Development of Formula composition, Manufacturing Process, and Optimization of Formula Composition and manufacturing process. • Preparation of Q1, Q2 Control request form, Maximum Daily Dose calculation request form, and IIG Declaration form. • Preparation of Master Formula Card, Q3 parameters study protocol, Q3 parameters study reports, and Stability protocol for Exhibit batches. • Quality target product profile based on drug substance and drug product. • Identifying Critical quality attributes and critical process parameters of drug products. • Risk assessment of Formulation components on critical quality attributes. • Execution of scale-up batches and Exhibit batches at plant level. • Troubleshooting during development and scale-up batches. • Maintaining inventory of all components including raw materials and packing materials. • Following Good Development Practices and Good Laboratory Practices. Good Laboratory Practice (GLP), Technology Transfer, Validation, and GMP. Strong research professional with a Master\'s degree focused in Pharmaceutical Sciences from Jawaharlal Nehru Technological University, Kakinada.