GMP Consultants


Phase 01

Our GMP consultants with their rich and varied experience in setting up state of art manufacturing facilities conceptualizing your dream project according to budget and regulatory.
During the initial planning stage various questions come up like:

  • How to design the right layout meeting requirements of men / material movement and at the same time ensure maximum utilization of usually scarce space?
  • What should be the correct environmental cleanliness class, which is acceptable?
  • How to design an air handling system meeting the requirements of room cleanliness classification and environmental protection?
  • What should be the quality of water used?
  • What should be the ideal water treatment method?

Based on the above discussion with the client we will develop:

  • Master Site Plan
  • Preliminary layouts for facilities
  • Size Process Equipment’s and outline basic specifications
  • Define Environmental classification and Pressure Differential concepts
  • Water treatment concepts
  • Civil Finish Concepts
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Basic engineering
I 3 Consulting can develop basic engineering designs customized to your functional and location requirements and recommend cost-effective solutions to meet regulatory norms.
During BASIC ENGINEERING the following definitions of the project will be developed:

  • Alternative plant layouts which meet GMP requirements
  • Men/material flow drawings on the approved layout
  • Conceptual design paper on Heating, Ventilation, Air Conditioning and Pressure Differential system with proposed Air Flow Diagram
  • Conceptual design paper on treatment, purification, filtration and distribution of various utility systems like Water, Steam, Compressed Air, Gases, Solvents, etc.
  • Estimate requirements of various utilities
  • Develop P&IDs for Process and Utilities
  • Estimate Electric Power requirements for the plant and suggest High Tension and Low Tension Distribution schemes
  • Conceptual design for ETP and Firefighting Systems
  • Prepare civil finishes schedule

Our GMP Consultants will not provide the below services

  • Detailed engineering
  • Procurement assistance
  • Project and construction management
  • Qualification & validation

Phase 02

GMP Documentation

  • Quality Assurance Procedures
  • Quality Control Procedures
  • Raw Material Specifications
  • Finished Product specifications
  • Packaging Material specifications
  • Equipment Cleaning Procedures
  • Manufacturing batch records
  • In process Test specifications
  • Stability Protocols

Regulatory:

  • Drugs Master File in CTD format
  • Site Master file as per PIC/s & Local FDA requirement.
  • Liaison with FDA for drug License
  • WHO-GMP Product Certification.
  • Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms

Training Programs on:

  • Standard Operating Procedures –QA/QC/Manufacturing /Maintenance
  • On the job Training for QA/QC/Shop floor employees
  • Process Validation
  • Installation Qualification
  • Operational Qualification Method Validation
  • Facility Qualification
  • Purified Water validation
  • Current Good Manufacturing Practices (cGMP)
  • Good laboratory Practices
  • How to prepare & face Regulatory audits
  • WHO guideline
  • Technology Transfer
  • Statistical Process Control

International Certifications:

  • ISO 9001
  • ISO 13485
  • OHSAS
  • WHO GMP
  • USFDA
  • FDA 510k
  • CE MARKING
  • 21 CFR 820/210
Contact us for more information – enquiry@i3cglobal.com

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INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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mail enquiry@i3cglobal.com

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