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Good Engineering Practice

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engineering qa production documentation review

Engineering QA / Production Documentation Review

Qualified and experienced professionals

GAMP Group provides an exceptionally skilled team of Quality ,Production ,architects and engineers to perfect your project, including process, mechanical, HVAC, electrical, automation, and validation specialists in the fields of pharmaceutical, medical device ,biotech & food processing facilities.

The design phase of a new facility lays the groundwork for the performance of your business. Well-founded conceptual design is crucial to the performance of any new facility because it influences not only your end product’s quality but also your cost of production, your ability to deliver on time, and the safety of the operation.

Our engineering design services always employ a comprehensive approach to meet your current and future needs.

  • Definition of best working practices
  • Technology fit for purpose
  • Optimization of capital investment & operating costs
  • Assured product quality while achieving optimal manufacturing efficiency
  • Compliance with international GMP & industrial safety standards
  • Environmental impact

Our conceptual design services will give your project the best possible start.

Strategic consulting & feasibility studies

We assist you to make critical decisions on your project viability by determining the financial outlay (CAPEX and OPEX), evaluating potential and current market trends, risk assessments, sales forecasts, and competitor analysis.

Site master planning

In this phase, a site investigation will be conducted jointly with you to gather relevant information required to design the building areas, production space, and logistics movement, do the infrastructure planning and

optimization for future expansion, as well as to meet regulatory compliance both locally and internationally.

With all these elements taken into consideration, visuals of the new facilities will be developed and presented to you.

Conceptual design

Study defining the purpose of a project, the location and cost assessment. The development stage defining the type, utilization and location of machines, processes, and plant services within a factory to meet output, quality, safety,

and regulatory demands; provides the operational philosophy, the layout and cost estimate.

Production building layouts will be developed based on the production equipment and operational requirements, to facilitate smooth production flow and maintenance works.

Layouts will also be developed for laboratories, warehouses, offices, and other required support areas.

During this conceptual design phase, the initial project investment cost estimates will be established for our clients.

Basic engineering

The basic design phase will advance the design across the various engineering disciplines, including process, architectural, structural and civil, utilities, HVAC, electrical, and fire.

The major objective of this phase is ensuring all major building elements, equipment, and systems are defined and accounted for in the overall design, and that everything is laid out in an optimal fashion, maximizing operational efficiency and minimizing costs.

The basic design will provide an approved set of drawings and documents defining the basis of design for the facility, allowing the project to subsequently be fully engineered with changes mitigated. Capital investment costs will be further refined to provide more accurate project cost estimates.

Detailed engineering

Our detailed design package provides over 500 items – including all the drawings, specifications and documentation needed to progress the project into the implementation phase.

As part of this engineering phase we produce a comprehensive package of technical information that will be used as a basis upon which to purchase, build, install, commission, validate and qualify your facilities and equipment.

Your Benefits :

  • Comprehensive & compliant designs
  • Proven track record based on experience
  • Flexible in customization & planning

Commissioning & Qualification Documentation Review for all equipment, Utilities & facilities.

Review Documentation for all validation requirements from project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, PV to Validation report writing.

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Talk to our team

Talk to us about your next validation or monitoring project.

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