Ashok Panwar

Background

About Ashok Panwar

I am having over 30 years of experience in Pharmaceutical Industry. First, over 7 years, have worked in API, Intermediate and Specialty Chemicals and for the last over 23 years, have been working in Drug Products [OSD, Liquid Oral, Ointments, Injectables,Vaccines, Biosimilars, Herbal products]. Of these 23 years, 13 years, have worked in Biotech [Vaccines + Biosimilars]. In Panacea Biotec, have led the team for getting world’s first fully liquid Penta Valent [ DwPT+Hib+Hep-B] approval from WHO and also headed Quality Organization for obtaining several WHO approvals for Oral Polio Vaccines other DTP family vaccines. Played a key role as Head-Quality by providing high quality Oral Polio Vaccines in getting Polio eradication from India. All these years, have gained expertise in CQA, Audit & Compliance, Remediation Plans & Compliance,QA, QC, AMV and RA for API, API based Finished Products sterile and non-sterile (Injectable, Solid oral, liquid, soft gel, ointments), bulk antigens for vaccines, Vaccines (Oral & Injectable sterile), Biopharmaceuticals(Biosimilars) and Herbal products (DS & DP, POM). A very sound knowledge of QMS and Global Regulatory Requirements i.e. US FDA, UK- MHRA, EU, TGA (AUS), ANVISA (Brazil), ROW, WHO, PIC/S and Indian etc. Multiple times successfully faced US FDA, EU, ANVISA (Brazil), TGA, WHO and ROW site audits. To my Credit, my very first US FDA inspection was with zero 483, and rest others were also successful first time and later on from these regulatory agencies multiple times. In all, have faced over 200 regulatory site inspections so far and performed over 100 plant audits as a part of Vendor Qualification, Regulatory Tox studies (Non-Clinical) CRO’s and CRO’s for Clinical Trials (Phase-I, II and ) in USA, EU, China and India My Area of Expertise are: 1. Audit and Compliance 2. US FDA Inspections 3. EU Inspections 4. Inspection Readiness 5.Remediation 6. Quality Strategy 7. QMS [Global] 8. OOS/OOT 9. Investigations 10. Quality Risk Management 11. API 12. Validations [ CSV, AMV, PV, Cleaning ] 13. CAPA Management and response to 483 14 Regulatory 15. Injectables 16. OSD 17. Data Integrity 18. Liquid Orals 19. Herbals [ NCE, POM] 20.Vaccines [ DS and DP] 21 Bio-similars [ Similar Biologic] 22. Biotech 23 Trainings 24. e-QMS 25. LIMS 26. QC 27. Analytical Method Development and Validations 28. CRO Selection [ Tox and Clinical] 29. Due- Diligence