Gamp Technologies Pvt Ltd. one of the renowned consultancy company serving technologies to Pharma and Biopharma.
Gamp Technologies Pvt ltd. is one of the major leaders in Pharma Turnkey Projects and Consultancy & Engineering. We serve Pharmaceuticals, API & Biopharmaceuticals from Concept to Validation.

SERVICES WE PROVIDE

1) DESIGN & ENGINEERING

  • Front End Engineering
  • Detailed Engineering.
  • Procurement Assistance

FRONT END ENGINEERING

Site Master Planning, Conceptual Design Development, cGMP Layout, Risk Assessment, Containment Strategies, General Planning & Engineering, Equipment Sizing, Production capacity Planning, Basis of Design.

DETAILED ENGINEERING

  • Tender Documents for Architectural, Civil, Structural, Process, Mechanical, HVAC, Piping, Modular Panels/Clean Rooms, Electrical, Instrumentation, BMS, EMS, Fire Fighting, Clean Utilities, Black Utilities, Warehouse, QA/QC. Bill of Quantity, Revit 3D Design on BIM Platform, Technical Data Sheets, Technical Specifications, Approved Makes List, Good for Construction Drawings.

PROCUREMENT ASSISTANCE

Vendor Selection for Equipment & Contracts, Floating of Enquiry and Tender Documents, Follow up for proposals, Technical Evaluation, Techno-Commercial Comparison, Technical Recommendation of suitable vendor.

2) TURNKEY PROJECT SOLUTIONS

    • Plant layout as per GMP
    • Civil Designing
    • Heat ventilation & air conditioning (HVAC) designing
    • Electrical engineering
    • Utility design
    • Capacity designing & machinery selection
    • Documentation

      We can deliver one stop EPC (Engineering, Procurement & Construction) solutions to Clients. Our team is capable to work in different combination of responsibilities delivering solutions based on client requirements. This EPC contract includes complete construction of infrastructure, supply and commissioning of production machinery and systems.

3) QUALIFICATION & VALIDATION

  • Development of Qualification Protocols for Equipment & Automation
  • Factory Acceptance Test
  • Site Acceptance Test
  • Development of DQ, IQ, OQ and PQ Documents
  • Review and Develop User Requirement Specification (URS)
  • Review of Functional Design Specification (FDS) of equipment
  • Qualification Schedule
  • Validation Master Plan (VMP)
  • Equipment Validation
  • Utility and Facility Validation
  •  Risk & Impact Assessment

4) REGULATORY COMPILANCE

    • Preparation and review of Drug Substance and Drug product registration dossier
    • Dossier Preparation & Submissions in CTD
    • Drug Firm Establishment Registration
    • Preparation and review of DMF [Drug Master Files]
    • Critical Review of Dossiers
    • Compliance audits as per current and updated statutory pharma regulations
    • GAP Analysis against regulatory requirement
    • Liaison for DCGI licensing & FDA, CDSCO activities
    • Support in Outsourcing Manufacturing or Testing Laboratories for Clients
    • Strategic assistance in Pharma Regulatory filing
    • Site Master file as per Local FDA requirement
    • Preparation and review of standard procedures and polices
    • Audit readiness
    • Response writing/ technical writing
    • Establishing and reviewing QMS

5) TRANING AND DEVLOPMENT

    • • Quality by Design
      • Water system and HVAC
      • Quality Risk Assessment (ICH Q9)
      • GxP compliance (Computer System Validation)
      • Operational Excellence (Six Sigma Methodology)
      • 21 CFR Part 210, 211
      • EU GMP (Eudralex Volume IV)
      • Schedule L1 & Schedule M (Drug & Cosmetic Act India)
      • Investigation, Root cause analysis and CAPA
      • Data Integrity
      • Train The Trainer
      • Critical machines like compression, Capsule and Blister machines
      • Microbiology and Aseptic practices
      • Quality control best practices
      • Quality management system
      • Hosting regulatory Inspections