Dr. A.K.Sabharwal

Dr. A.K.Sabharwal has an illustrious career spanning over 35 years of research and industrial experience in Total quality management in pharmaceutical industry related to Dosage forms, API’s and their intermediates.

At present he is President, Pharmaffiliates Analytics & Synthetics (P) Ltd. And also Chairman of Pharmaffiliates Asia Research
Foundation. Besides this, he is auditor for Government Drug Authorities of National Capital Territory of Delhi, India and teaching faculty(External) National Institute of Pharmaceutical Education and Research(NIPER), S.A.S Nagar, Punjab

In his 35 years of research and industrial experience in Total Quality Mangement in Pharmaceutical Industry he has successfully faced numerous inspections conducted by US-FDA, MHRA, TGA Australia, HPB Canada & Hungarian Health Authorities etc. where in Approval of numerous Dosage forms, APIs and their Intermediates from each of the Regulated Authorities viz. US-FDA, MCA-UK, MCC, MHRA, TGA Australia, HPB Canada & Hungarian Health Authorities etc.

He has Sound knowledge of Pharmaceutical validations, GMP training and Auditing. He is acting Co-ordinator for outsourcing of Bulk Actives and Third party manufacturing, well conversant with technical administration of allied functions Viz. Process Development, Trouble shooting and Validations etc.

He has also performed number of 3rd party audits for European Customers

AUDITS PERFORMED:

PROJECTS HANDLED:

• Transfer of Technology from R & D to Manufacturing. Process validation including Analytical method validation.
• Defining Quality Systems in the Pharmaceutical units
• Preparing Pharmaceutical companies for Overseas Inspections
• Assisting Projects in setting up of New Laboratories and Manufacturing facilities.
• Assisting Marketing in the Techno-commercial discussions
• Assisting Marketing personnel in establishing Newer Markets
• Worked for joint ventures viz. Solvay – Dishman, Ranbaxy-Schien, Ranbaxy-Elly Lilly etc.
• Imparting Training to People
• Submitting Dossiers and their Approval from the Worldwide Regulatory Authorities for Bulk actives and Dosage forms. Has hands on experience for making EU and US submissions, running DCP, MRP and CP procedures for MA.
• Responsible for responding to various technical queries received from different Regulatory Authorities within a time frame by coordinating with various technical groups for data generation.
• Conduct Technical discussions with US-FDA/ MHRA/TGA Inspectors and Overseas Customers/Consultants during Visits/Audits during their visits.
• Evaluate the Manufacturing Process from the Patent infringement for the submission in the Regulated countries. Co-ordinate with the Overseas Patent Attorneys for clarifications from time to time.
• Guide Plant personnel for carrying out Validations in their respective areas viz. IQ/OQ/PQ, Computer validation, Analytical method validations, Process validation, Cleaning validation, Annual Product review etc.

PUBLICATION / APPRECIATIONS:

• Successfully faced 14 inspections conducted by US-FDA, MHRA, MCC, TGA Australia, HPB Canada & Hungarian Health Authorities etc.
• Published five Research Papers in the International Journals
• Examiner for the Dept. of Pharmaceutical Sciences, Punjab University, Chandigarh.
• Teaching M. S. Classes in Pharmaceutics at NIPER, S. A. S. Nagar, Punjab, India
• Chaired two scientific secessions on Pharmaceutical Analysis in 46th Indian Pharmaceutical Congress held in Chandigarh.
• Attended number of Management /Technical courses in India and abroad. Delivered lectures on Quality Management and Analytical Validations.
• Approved Analytical Chemist from State Drug Controller, Punjab.
• Life member of Indian Pharmaceutical Association