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Pharmaceutical Industry Departments roles and responsibilities manasa life sciences
- 1. Pharmaceutical Industry Departments Roles and Responsibilities Dr. Useni Reddy Mallu Mobile: 7901020060 E-mail: info@manasalifesciences.com Website: www.manasalifesciences.com
- 2. R&D AR&D DQA SCM Purchase Operations Production QA QC Patents Product Portfolio Marketing Logistics Regulatory Affairs Engineering Product Planning Finance Safety Pharmacovigilance Bio-Equivalence Technology Transfer Inspection team Business development Training Team Licence team Project Management Selection Development Manufacturing MarketingApproval Multi Functional Departments 26 Departments
- 3. Product Selection SCM Patents Product Portfolio Marketing Regulatory Affairs Finance Inspection teamBusiness development Licence team Project Management Key Departments Supporting DepartmentsKey Departments Supporting Departments
- 4. Development Stage R&D AR&D DQA SCM Purchase Patents Regulatory Affairs Bio-Equivalence Technology Transfer Training Team Licence team Project Management Key Departments Supporting DepartmentsKey Departments Supporting Departments
- 5. Manufacturing Stage SCM Purchase Operations Production Quality Assurance Quality Control Logistics Regulatory Affairs Engineering Product Planning Safety Technology Transfer Inspection team Training Team Licence team Key Departments Supporting DepartmentsKey Departments Supporting Departments
- 6. Product Approval AR&D DQA QA QC PatentsRegulatory Affairs Pharmacovigilance Bio-Equivalence Technology Transfer Inspection team Key Departments Supporting DepartmentsKey Departments Supporting Departments Purchase Production
- 7. Marketing Stage Product Portfolio Marketing Logistics Regulatory Affairs Product Planning Key Departments Supporting DepartmentsKey Departments Supporting Departments Pharmacovigilance
- 8. Departments R & R S.No. Departments R & R 1 Product Portfolio Drug profile, product biz volume, global requirement, drug nature, investment value, product time lines 2 Business development Product competitors, biz volume, target countries, development time lines, material cost 3 Project management Product time lines, development and stability time lines, innovator samples, logistics time lines 4 Finance Investment value, product life time, approval time, expenditure 5 R&D Product development, quality material sourcing, quality evaluation, lab scale stability, BABE studies, product technology transfer 6 AR&D Method development, validation, specifications, stability studies, vendor qualification, impurity profile 7 DQA Documentation practice, technology transfer, vendor qualification, training program 8 Technology transfer Product transfer, suitability of equipment, documentation practice, auditable document 9 SCM Material sourcing, vendor qualification, alternate vendor, material costing
- 9. Departments R & R S.No. Departments R & R 10 Bioequivalence BABE studies, bio results, number of subjects 11 Quality assurance Documentation practice, vendor qualification, facility audit, inspections, employee training, safety, material entry and exit 12 Quality control Product analysis, method verification, method validation, instruments qualification, vendor qualification, analyst training 13 Purchase Vendor selection, vendor evaluation, material inventory, material sourcing 14 Production Product manufacturing, documentation practice, product planning, employee training, material entry to exit 15 Regulatory affairs Product submission, regulatory guidance implementation, product approval, deficiencies, product life cycle, CTD submission 16 Inspection team Inspection leading, customer and agency audits, warning letters, inspection requirements 17 Pharmacovigilance Approved product life cycles, market complaints, product quality, patient complaints
- 10. Departments R & R S.No. Departments R & R 18 Marketing Product marketing, marketing companies support, logistics, finished product inventory, product sales 19 Logistics Product transport, custom clearance, material safety, 20 Training team Employee training, product training, equipment training 21 Safety Safety requirements, safety organogram, safety measurements, safety training 22 Licence team Product submission, product licence, market complaints 23 Product planning Product time lines, product manufacturing, pipe line production schedule 24 Operations Production monitoring, plant activities, public complaints, product planning, material inventory, casual employee management 25 Patents Innovator patents, patent claims, patent expiry, patent challenge, product requirements 26 Engineering Equipment qualification, new equipment installation, training, equipment service, breakdown monitoring