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 Management

COMPUTER 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 Mapping

Cleanroon and HVAC Qualification

ISOLATOR | 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 Audits

GMP COMPLIANCE SERVICES:
- System based GMP Audit -> Gap Analysis -> Recommendations -> Implementation with respect to facility, utilities, process equipment, lab instruments, computer systems and quality management system

FACILITY CONCEPT DESIGNS, BASIC AND DETAILED ENGINEERING SERVICES
- Facility cGMP Design Gap Analysis
- Facility revamp and Modernization

MEDICAL 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 Books


Contact us:
+91 9599579585
info@ipharmatecsolutions.com
ipharmatecsolutions@gmail.com

iPharmatec Solutions

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iPharmatec Solutions

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