Hire Manish H. Nakum, a pharma consultant specializing in Drug Development, 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: Manish H. Nakum is a pharmaceutical manufacturing professional with over 18 years of experience in bulk drug production, including oncology and highly potent active pharmaceutical ingredients. His expertise includes API process scale-up and optimization, process validation, equipment qualification support, GMP compliance, GMP training, deviation investigations, change management, and corrective and preventive actions. His career includes roles with Intas Pharmaceuticals, Unimark Remedies, Glenmark Generics, and Orchev Pharma. He brings hands-on experience in commercial batch execution, technology transfer from R&D to plant scale, critical process parameter monitoring, and production documentation. His background also includes manufacturing improvements focused on yield, impurity reduction, and cycle-time efficiency. He helps pharmaceutical teams strengthen production practices, support validation activities, and address manufacturing quality issues. - Show More
Manish supports API process development through manufacturing scale-up, technology transfer, and process optimization for oncology and highly potent APIs. His experience includes transferring processes from R&D to plant scale, executing development batches, and improving filtration and washing operations. He helps teams assess manufacturing bottlenecks and identify opportunities to improve yield, impurity control, and production efficiency.
Manish supports CAPA activities for API production through preparation of root cause analysis and corrective and preventive action documentation. His experience combines manufacturing investigations, procedural updates, and operator training. He helps production teams connect identified causes with practical actions addressing process execution, documentation, and human-error risks.
Manish supports change management for API manufacturing through initiation of change controls and revision of SOPs and batch manufacturing records. His background includes process improvements involving reagent grade, filtration, washing, and production scheduling. He helps teams document proposed changes and coordinate manufacturing input for quality review and implementation planning.
Manish supports manufacturing deviation management through initiation of deviation records, root cause analysis, and preparation of investigation documentation. His experience includes addressing production quality issues and improving process operations to reduce impurities and avoid reprocessing. He helps teams assess manufacturing information and document findings in coordination with quality assurance.
Manish supports equipment qualification through preparation of user requirement specifications and participation in IQ, OQ, and PQ activities for containment and utility equipment. Drawing on his oncology and HPAPI manufacturing experience, he helps teams define operational requirements and coordinate production input during equipment qualification activities.
Manish supports GMP compliance within API production through shop-floor oversight, batch documentation, SOP implementation, and monitoring of manufacturing practices. His experience includes participation in US FDA, EU GMP, and WHO GMP audits. He helps production teams maintain controlled records, follow approved procedures, and apply appropriate HPAPI handling and containment practices.
Manish provides practical training for production officers and operators on cGMP practices and HPAPI handling. His experience includes leading manufacturing teams across shifts and training personnel to reduce human-error deviations. He helps teams understand production procedures, documentation responsibilities, and containment practices relevant to oncology and highly potent API operations.
Manish supports process validation through hands-on execution of process performance qualification batches and monitoring of critical process parameters. His experience includes coordinating production activities and generating manufacturing information for regulatory documentation. He helps teams execute validation batches according to approved instructions and document process performance during scale-up and commercial implementation.
