Hire Bhagwati Makwana, a pharma consultant specializing in FDA Inspections and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: B. Makwana is an accomplished pharmaceutical Quality and Compliance professional with over 43 years of experience across Quality Assurance, GMP Audit, Third Party GMP Audit, GMP Compliance, Quality Management System, GMP Training, and FDA Inspection Readiness. His career spans solid oral dosage forms, effervescent tablets, sachets, lozenges, liquid products, parenterals, APIs, and intermediates, with around two decades in senior leadership positions. He has extensive exposure to USFDA, TGA, MHRA, WHO, and international customer audits and has completed more than 65 independent GMP audits of drug-product and API suppliers in India and overseas. His consulting experience includes QMS implementation, regulatory gap assessments, CAPA, investigations, qualification and validation oversight, facility review, regulatory documentation, audit preparation, and training programs for personnel ranging from shop-floor employees to senior management. - Show More
Bhagwati Makwana has substantial experience preparing and supporting pharmaceutical facilities for USFDA and other global regulatory inspections. He has served as a team leader during USFDA exposure at a formulation facility, supported API inspection activities, and worked as a consultant at customer sites during USFDA and other regulatory audits. His consulting work includes compliance preparation, facility gap analysis, QMS review, training, and implementation of corrective actions to improve inspection preparedness.
Bhagwati has strong experience in facility audits, gap analysis, internal audits, customer audits, regulatory assessments, and evaluation of pharmaceutical quality systems against global GMP expectations. He has supported both API and finished-product organizations and can help identify compliance gaps, assess current practices, review CAPA responses, and recommend practical improvements.
Bhagwati has extensive experience with US, EU, and international GMP requirements and has supported pharmaceutical organizations in establishing compliant systems, assessing regulatory gaps, preparing documentation, and implementing corrective actions. His background includes exposure to USFDA, TGA, MHRA, WHO, and other regulatory inspections across API and drug-product facilities.
Bhagwati is an experienced GMP and TQM trainer and has delivered programs on cGMP, GLP, SOPs, Quality Management Systems, CAPA, investigations, Quality Risk Management, and related compliance topics for personnel ranging from workmen to senior management. He also served as a TQM Champion for seven years and conducted around 55 training sessions across different organizational levels.
Bhagwati has extensive Quality Assurance experience across pharmaceutical formulations, APIs, and intermediates, with a career spanning senior roles including Head of QA, Manager QA, GM Quality, and independent consulting. His experience includes SOPs, batch documentation, deviations, change control, OOS, non-conformances, CAPA, complaints, APQR, internal audits, qualification, validation, and overall quality-system oversight. He can support pharmaceutical organizations in strengthening QA governance, documentation systems, and sustainable regulatory compliance.
Bhagwati has strong experience implementing, reviewing, and improving pharmaceutical Quality Management Systems. His consulting work covers CAPA, Quality Risk Management, investigations, stability management, qualification, trending and data analysis, technology transfer, documentation harmonization, and evaluation of QMS implementation.
Bhagwati has significant independent third-party auditing experience. As a neutral auditor for overseas customers, he has conducted more than 65 GMP audits of Indian and international suppliers covering drug products and APIs, including assignments in India and overseas. He also has experience reviewing CAPA responses submitted by audited organizations.
