USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

  • Transforming the future, block by block

Installation, Commissioning and Validation

Our commissioning and qualification team has the technical skills and experience of Pharmaceutical Machines and Equipment to make our clients' projects successful. We apply industry knowledge to understand the risk, identify and solve the bottlenecks and ensure that execution of the project is seamless and in accordance with GMP guidelines. We, as expert GMP consultants, ensure that we follow international and local regulations in projects we execute.

The audit and quality management system in place shall rectify problems before they become big and thus create an environment where fast correction leads to right methodology of execution, commissioning and validating the Pharmaceutical facility thus completing a crucial link in Turnkey Pharmaceutical Engineering.

Our team is equipped with various international guidelines for installation and commissioning of Pharmaceutical facilities including ASTM E-2500, ISPE and CGMP. The various stages of installation and commissioning are:

  • Installation Plan with defined sequence of activities of installation
  • Preparation of the specification measurement document
  • Mobilization of expert staff
  • Daily installation progress, feedback mechanism and course correction techniques
  • Field Report generation
  • Phased wise commissioning line-up
  • Data recording and commissioning set-up
  • Monitoring and testing
  • Validation

The activity begins with providing Validation Master Plan and thereby supporting our customers to the very end of total validation of the facilities.

Our team can provide commissioning documents that verify proper installation, operation at start-up, functional performance, and turnover of facilities, systems and equipment. Commissioning services include SAT (Site Acceptance Test), to ensure all systems are supplied in specified condition.

Extended Services:

  • Risk assessment
  • SAT preparation and conclusion
  • Documentation
  • Project Management
  • SOP development
  • Calibration and testing
  • Training

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