revamp upgradation

21-CFR-11 Compliance Project

Revamp, Upgradation & Retrofitting -21-CFR-11 Compliant Project

GAMP Group has developed considerable technical expertise for Revamp & Upgradation of 21-CFR-11 Compliant Upgradation Project throughout its history.. GAMP Group offers Revamp ,Retrofitting & Upgradation services for any equipment of any brand under 21-CFR-11 Compliant Upgradation Projects.

21-CFR-11 Compliant Upgradation Project or Revamp, Retrofitting & Upgradation Projects may be necessary to comply with up-to-date industry regulations and standards. Older Equipments may not meet current safety and efficiency requirements, which can result in financial loss (or penalties) for the company. Revamp ,Retrofitting & Upgradation allows companies to meet these updated requirements and ensure they are operating safely and efficiently.

Another reason to consider Revamp, Retrofitting & Upgradation is to improve the GAMP 5 Compliance of the All equipments under 21-CFR-11 Compliant Upgradation Project. Over time, a company’s production demands can increase, which means their equipments may not be large or efficient enough to meet their needs. Revamp, Retrofitting & Upgradation can include the installation of additional capabilities, such as an automatic loading and unloading system, to improve its efficiency and reduce downtime.

The structure of a medical device QMS

revamp upgradation infographics

CFR-11 Compliant Upgradation Project

We use Branded PLC + HMI + SCADA like Siemens, Rockwell, Mitsubishi for our 21-CFR-11 Upgradation Project.

We have a team of 12 Experience Automation Engineers with GMP and GAMP Compliance and Regulatory understanding.

01

GAMP Group has expertise in Upgradation of Parenteral, API & Formulation Equipments

  • Washer, Tunnel, Filling, sealing, capping M/c.
  • Steam Sterilizers
  • Freeze Dryers
  • Manufacturing Vessels
  • SIP/CIP Unit
  • Part Washer
  • Fumigators H2O2
  • Leak Testing
  • Visual Inspection M/C etc.
02

Solid Oral Machineries

  • Compression Machines
  • FBDs, FBEs
  • RMG
  • Blenders
  • Spray Dryer etc.
  • Packing Machineries
  • Blister Pack
  • Tablet Counting Machine
  • Labelling Machine
  • Check Weigher
  • Labelling M/C etc.
03

Utility Machineries

  • EMS/BMS System
  • AHUs and Dehumidifiers
  • Water Pre-treatment Plant
  • R.O. Plant
  • P.W Generation & Loop System
  • WFI Generation & Loop System
  • Pure Steam Generation etc.
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