Hire Manu Kashyap, a pharma consultant specializing in Medical Devices, Pharmaceutical Manufacturing, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Manu Kashyap is a principal GMP consultant and auditor with 22+ years of pharmaceutical industry experience, with deep expertise in sterile manufacturing, cGMP compliance, qualification, validation, regulatory audits, and inspection readiness. His work is strongly execution-focused, combining extensive shop-floor experience with global regulatory understanding across USFDA, EU GMP, WHO, PIC/S, ANVISA, and MFDS expectations. He supports pharmaceutical organizations with practical, risk-based consulting that strengthens compliance maturity, improves inspection preparedness, and builds sustainable quality culture across operations. - Show More
Manu brings particularly strong value in aseptic manufacturing, which is one of the clearest strengths reflected across his profile. The materials describe more than 22 years of experience in pharmaceutical sterile manufacturing, strong expertise in aseptic processing and contamination control, training in aseptic processing and cleanroom behavior, and support for aseptic process simulation alongside inspection readiness and validation activities. He has also worked extensively with sterile manufacturing equipment and sterile finished dosage form environments, including greenfield and brownfield projects. As a result, his aseptic manufacturing support is highly practical and execution-driven, helping organizations strengthen cleanroom discipline, operator behavior, contamination control strategy, process robustness, validation readiness, and regulatory confidence. His work is especially suited to companies that need to bridge the gap between written aseptic requirements and consistent, compliant performance on the shop floor.
Manu supports CAPA programs through hands-on gap assessment, remediation planning, and execution-focused quality system improvement. The submitted materials specifically highlight weak deviation investigations, ineffective CAPA, and recurring observations as common client pain points, while also stating that his services include end-to-end remediation support, CAPA development and execution, SOP enhancement, and compliance support for audit observations and regulatory findings. His CAPA consulting is therefore centered not only on closing observations, but on identifying root causes, improving investigation quality, strengthening procedural controls, and embedding corrective actions into routine operations so that the same issues do not repeatedly return. With direct inspection exposure across regulators including USFDA, EU GMP, WHO, ANVISA, and MFDS, he helps clients build CAPA systems that are more robust, practical, and capable of withstanding regulatory review.
Manu supports cleaning validation within a broader GMP and lifecycle-based compliance framework, especially in regulated manufacturing environments where process understanding, contamination control, equipment knowledge, and validation discipline are critical to product quality and inspection success. His profile emphasizes deep experience in sterile manufacturing, qualification, validation, risk-based compliance, and translating regulatory expectations into practical shop-floor execution. This allows him to help manufacturers build cleaning validation programs that are scientifically justified, operationally workable, and inspection-ready rather than documentation-heavy but weak in execution. His approach is particularly valuable where sites need stronger validation logic, better linkage between procedures and actual practice, and more reliable control over cross-contamination risk, equipment cleanliness, and long-term GMP consistency.
Manu supports equipment qualification through end-to-end lifecycle-based execution aligned with current GMP and validation expectations. His expertise covers qualification and validation of critical manufacturing equipment, with specific exposure to sterile manufacturing systems such as steam sterilizers, autoclaves, vial washers, depyrogenation tunnels, filling and sealing machines, lyophilizers, isolators, and visual inspection systems. His profile also emphasizes strong understanding of qualification stages including URS, DQ, IQ, OQ, and PQ, along with the common client challenge of limited technical understanding of equipment working principles during qualification and validation. He helps organizations build technically sound, inspection-ready qualification programs that improve equipment reliability, process control, compliance confidence, and alignment between validation documentation and actual shop-floor execution.
Manu supports facility qualification with a strong focus on sterile and highly regulated manufacturing environments where system performance, environmental control, and operational discipline are essential for compliance. His company profile specifically includes qualification and validation support for HVAC systems, water systems, clean utilities, and cleanroom qualification, supported by deep understanding of sterile manufacturing, aseptic processing, contamination control, and regulatory inspection behavior. He helps organizations assess whether facility systems are designed, qualified, and operated in a way that supports consistent GMP performance, product protection, and inspection readiness. His approach combines regulatory depth with shop-floor practicality, making facility qualification more than a documentation exercise by linking system capability directly to operational risk, contamination control strategy, and long-term compliance reliability.
Manu supports GMP audits through a strongly practical, risk-based approach built around real manufacturing conditions rather than checklist-only review. His consulting profile highlights support for second- and third-party audits, mock inspections, inspection readiness programs, and structured compliance assessment across APIs, sterile and non-sterile dosage forms, pellet facilities, and primary and secondary packaging material manufacturers. He helps organizations evaluate procedures, systems, facilities, equipment, and day-to-day practices against current global regulatory expectations, while identifying critical, major, and minor gaps that may affect inspection outcomes. With deep exposure to USFDA, EU GMP, WHO, PIC/S, and other inspection environments, his audit support is designed not only to identify observations, but to improve readiness, strengthen quality culture, and embed sustainable compliance across operations.
Manu supports GMP training through practical, shop-floor-oriented programs that help teams convert regulatory expectations into disciplined daily execution. His training areas include cGMP, aseptic processing, cleanroom behavior, data integrity and ALCOA+ principles, and qualification and validation practices, making his support highly relevant for sterile and highly regulated manufacturing operations. Rather than treating training as a one-time compliance activity, his approach focuses on capability building, quality culture development, and operational consistency so that teams are better prepared for audits, investigations, and routine GMP performance. This makes his training support especially valuable for organizations aiming to improve inspection readiness, reduce compliance gaps, and strengthen long-term quality behavior across technical and operational teams.
Manu supports process validation with a strong emphasis on lifecycle-based execution, technical understanding, and practical manufacturing alignment. His profile highlights end-to-end validation lifecycle exposure, including URS, DQ, IQ, OQ, and PQ, along with deep understanding of the process knowledge required to plan and execute validation effectively in regulated pharmaceutical environments. He helps organizations develop scientifically sound and inspection-ready validation strategies that connect process design, equipment capability, utility readiness, and operational discipline. With strong exposure to sterile manufacturing, aseptic operations, and qualification-driven compliance, he supports companies in building validation programs that improve process consistency, strengthen regulatory confidence, and reduce the risk of gaps during commercial readiness or inspection review.
Manu supports Quality Management System Regulation (QMSR) through practical, implementation-focused quality system development designed for real pharmaceutical operations rather than documentation alone. His work covers SOP systems, deviation management, CAPA, change control, data integrity practices, and broader compliance frameworks that help organizations strengthen day-to-day control across regulated manufacturing environments. With strong sterile manufacturing and validation experience, he helps companies close the gap between written procedures and actual shop-floor execution, making quality systems more consistent, inspection-ready, and sustainable. His approach is especially valuable for organizations looking to improve compliance maturity across sites, reduce recurring observations, and build a stronger culture of quality that can withstand regulatory scrutiny over time.
