Prashant S Khemariya (Ph.D., M. Pharmacy)
Passionate about product development.
(Manager- Formulation; US, EU and SEA market).
[8 Awards, 20+ Publications with 10 years of rich research experience in-Pharmaceutical and Biotech (Protein-Peptide) drug delivery systems including NDDS with global regulations-INDA, NDA, ANDA, PAT, SUPAC, FDA, GMP, GLP, MHRA, TGA, USFDA, ICH, QSR, CFR-21.]
Manager-Formulation and DevelopmentGeorge Town Penang Malaysia
Since July 2015
Pilot scale batches
- Responsible to lead, manage and motivate the team of brilliant research scientists, from development till the commercialization of a wide range of lifesaving drug products and process as per market demand (early and late stage).
- Evaluate literatures, patents, reference product profile and monograph and develop non-infringement strategies.
- Follow Quality by Design (QbD) concepts, FDA guidance and company’s standards for development.
- Pre-formulation study, feasibility data, stability study (as per ICH/SUPAC/NPRA) and planning for primary packing as per availability of equipment and respective change parts.
- Preparation of trial and pilot scale batches in pilot lab to determine a suitable and robust process (using engineering principles and methodologies) which will yield stable product at the commercial site.
- Responsible for drug product process characterization, optimization and technology transfer from laboratory to the soft floor. Scale-up & variations as per
- Process Analytical Technology implementation and life cycle management with respect to CPP, CQA to enhance the quality, efficacy and productivity of products.
- Responsible for implementation and maintain a state of the art process development
- Provide technical leadership on project teams and task groups Validation (process validation, cleaning validation, filter validation, filling validation, hold time study for products and equipment, protocol, report and scheme) and post activity.
- Support in analytical method development (HPLC, UV, Micro etc.) and In vitro/In vivo (BE) study.
- Development of new technologies & advances in Parenteral, oral liquid (syrup, suspension), Ophthalmic, oral solid and semisolid formulations by defining target, product profile.
- Development of techniques as like, dendrimer, co-crystallization, lyophilization, and co-solvency for improvement of solubility of poorly soluble drugs for parenteral dosage form.
- Development of techniques for taste masking of bitter drugs for formulation of oral dosage form.
- Provide support on the soft floor during production and troubleshooting.
- Review and approval of all documents per FDA, GMP, cGMP, GLP Guidelines (SOP, BMR Products Quality Review, CAPA, Change control, deviation).
- Maintaining routine procedure for the calibration and validation of instrument and equipment respectively.
- Assists in executing development study plan for NDA and ANDA.
- Collaborate with team members (formulators and analytical chemists) to meet timelines for product development activities. Cost reduction of the pre-launched/marketed products.
- Vendors qualification and perform other duties as required or assigned by management.
Biostatistics Cell biology Biochemistry DiabetesProduct developmentGMPFDABiological Drug Development
Skills and Expertise
Establish contracts Technology researchSearch literature on clinical trialsRelease productsRegulatory submissionsRegulatory documentation
PhD Pursuing in Pharmacy from JNU in 2019
M Pharmacy in Pharmacy from RGPV India in 2010
Expert has 1 publications (Will be avalible with full profile)