Munish Kumar's Colleagues at iPharmatec Solutions
Munish Kumar's Contact Details
India
iPharmatec Solutions
Munish Kumar's Company Details
iPharmatec Solutions (IPTS) is a fast-growing international consultancy offering cGMP compliance, risk based commissioning, qualification and validation (CQV), computer system validation and engineering consulting services to pharmaceutical, bio-pharmaceutical and medical device industries.We provide our clients with a competitive advantage by helping them build, commission and operate manufacturing facilities that comply with International cGMP regulations.Services at a glance:Project Commissioning, Qualification and Validation (CQV) Execution and ManagementCOMPUTER SYSTEM VALIDATION: PLC, HMI, SCADA, Automation System, LIMS, ERP, MES, SAP Validation Field Execution (21CFR part 11, Annex 11, GAMP5)TEMPERATURE MAPPING: Warehouse, Autoclaves, Sterilizers, Dry Heat Sterilizer, Ovens, Incubators, Cold rooms Temperature MappingCleanroon and HVAC QualificationISOLATOR | CONTAINMENT SYSTEM VALIDATION- End to End implementation of Risk based Validation / Qualification System- Facility Risk Assessment {FMEA, HAZOP, HACCP, FTA etc.}- Risk-based Cleaning, Process Validation- Validation Protocols / Reports (URS, EDS, RA, DQ, FAT, SAT, IQ, OQ, PQ)- Suppliers AuditsGMP COMPLIANCE SERVICES:- System based GMP Audit -> Gap Analysis -> Recommendations -> Implementation with respect to facility, utilities, process equipment, lab instruments, computer systems and quality management systemFACILITY CONCEPT DESIGNS, BASIC AND DETAILED ENGINEERING SERVICES- Facility cGMP Design Gap Analysis- Facility revamp and ModernizationMEDICAL DEVICES REGULATORY SUBMISSION SERVICES- Medical device complete technical documentation including Software File (IEC 62304), Risk Management File (ISO 14971), Usability File (IEC 62366-1), Safety and Essential Performance File (IEC 60601-1) etc.GMP TRAININGS SERVICES- GMP e-Modules, GMP BooksContact us:+91 9599579585info@ipharmatecsolutions.comipharmatecsolutions@gmail.com