Hire Dr. Mahendra Mhamunkar, a pharma consultant specializing in Analytical Testing, Clinical Studies, FDA Inspections, Medical Devices, Pharmaceutical Manufacturing 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: Dr. Mahendra Mhamunkar is an independent GMP consultant and lead auditor with over 26 years of experience in pharmaceutical quality assurance, quality control, and regulatory compliance across API and formulation manufacturing. He has completed 900 audits across 16 countries and held quality leadership and auditing positions with Teva, Telstar, Symbiotec, Sophal, and Embio. His expertise includes GMP auditing, third party supplier assessments, FDA inspection readiness, warning letter remediation, quality management systems, and GMP training. He also supports regulatory submission documentation, analytical method validation, and facility qualification. His consulting experience includes guiding pharmaceutical manufacturers through compliance gap assessments, corrective action planning, and preparation for international regulatory inspections. - Show More
Dr. Mhamunkar provides facility qualification support for pharmaceutical manufacturing plants and laboratories. His experience includes facility, HVAC, utility, and laboratory instrument qualification at formulation plants in Europe, alongside facility design and regulatory documentation projects. He has also contributed to the design of a sterile oncology formulation plant against US FDA requirements. He supports clients in establishing documented qualification activities to demonstrate facility suitability for intended pharmaceutical operations.
Dr. Mhamunkar supports API and formulation manufacturers through FDA inspection preparation, including compliance gap assessments, quality system improvements, and documentation review. He has guided facilities from initial preparation through inspection completion, with experience providing extended consultancy at manufacturing sites. His background in site quality leadership and regulatory audit management enables him to help teams address deficiencies and prepare their operations for inspection.
Dr. Mhamunkar assists pharmaceutical manufacturers with FDA warning letter remediation through assessment of compliance deficiencies and preparation of corrective and preventive action plans. His experience includes supporting an OTC manufacturing site with CAPA addressing a talc-related FDA warning letter. He has also reviewed supplier compliance associated with warning letters during his global auditing work. He helps clients develop documented remediation actions that address the findings raised.
Dr. Mhamunkar conducts GMP audits for API and formulation manufacturers, laboratories, and pharmaceutical supply chain facilities. His experience includes assessments against EU GMP, ICH Q7, US FDA requirements, and other international quality standards. Drawing on extensive international auditing experience, he evaluates manufacturing practices, laboratory controls, quality systems, and documentation to identify compliance gaps. He also supports review of corrective and preventive action plans arising from audit findings.
Dr. Mhamunkar provides GMP and GXP training for pharmaceutical quality, manufacturing, and laboratory teams. His experience includes training QA personnel on regulatory requirements, guiding training managers, and approving GMP and GLP training programs at manufacturing sites. He draws on practical auditing and quality management experience to help teams understand compliance expectations and apply them to routine operations
Dr. Mhamunkar supports analytical method validation and method transfer for APIs and pharmaceutical formulations. His experience includes preparing and executing validation protocols for assay, related substances, dissolution, preservative content, and rinse or swab testing using HPLC and UV techniques. Drawing on his analytical chemistry background and work in corporate validation, he supports validation activities aligned with applicable pharmacopoeial requirements and ICH guidelines
Dr. Mhamunkar supports the preparation, implementation, and improvement of pharmaceutical quality management systems for API and formulation facilities. His experience includes establishing systems aligned with US FDA, EU GMP, and other regulatory requirements, as well as implementing cGMP practices in R&D and biotechnology laboratories. Drawing on senior QA and QC leadership roles, he helps organizations strengthen quality documentation, internal assessments, training, and compliance oversight.
Dr. Mhamunkar supports preparation and review of pharmaceutical regulatory documentation, including ASMFs, CEP applications, DMFs, and ANDAs. His experience includes reviewing drug master files and CTD documentation before overseas submissions and completing five new API DMF filings for the US and China markets. He helps manufacturers organize manufacturing and quality information to support regulatory submission activities.
Dr. Mhamunkar provides independent third party GMP audits for pharmaceutical companies and international auditing agencies. His experience covers API, formulation, intermediate, key starting material, excipient, and laboratory suppliers across multiple countries. His work includes planning and executing supplier audits, assessing compliance, and reviewing subsequent CAPA plans. He helps clients evaluate the quality practices of external manufacturing and testing partners.
