GMP Projects

EU GMP US FDA PICS or WHO Compliant New Project

Quality, Production & Engineering Design Documentation and Validation

Quality, Production & Engineering Design Review, Proposed Engineering Solution Documentation and Validation.

Qualified and experienced professionals

GAMP Group provides an exceptionally skilled team of Quality ,Production ,Architects and Engineers to perfect your New EUGMP USFDA PICS WHO Based New Project including process, mechanical, HVAC, electrical, automation, and validation specialists in the fields of pharmaceutical, medical device ,biotech & food processing facilities.

Our engineering design services always employ a comprehensive approach to meet current and future regulatory compliance 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

EUGMP USFDA PICS WHO Compliance Project:

When it comes to achieving EU GMP/US FDA compliance for your pharmaceutical production facility, you cannot afford to take risks.

GAMP Group is fast becoming the first choice EU GMP /US FDA compliance partner for manufacturers in the Asia/Europe/USA region.

Why? Because GAMP Group offers comprehensive in-house EU GMP /US FDA compliance services that will ensure a well-planned pathway towards EU market access.

Our EU GMP compliance services in 5 phases

• Phase 1: EU GMP reviews, gap analysis, remediation

• Phase 2: GMP training

• Phase 3: EU GMP audit preparation

• Phase 4: EU GMP pre-inspection audit by EU GMP partner

• Phase 5: Final liaison with EU authorities

Our experienced consultants will train and lead your team towards successful EU GMP certification by creating a GMP culture and mindset that will leave the auditors in no doubt of your readiness to comply with EU GMP requirements.

Our structured approach and rigorous GMP reviews and Gap analysis will serve to align your facility documentation and processes with EU GMP regulations and guidelines prior to the arrival of the auditors.

Furthermore, our European-based third-party EU GMP pre-inspection auditor will provide a thorough assessment of the facility’s readiness prior to inviting the EU regulators for the audit.

Our conceptual design services will give your New EUGMP USFDA PICS WHO Based New Project the best possible start.

Strategic consulting & feasibility studies

We assist you to make critical decisions on your New EUGMP USFDA PICS WHO Based New 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 New EUGMP USFDA PICS WHO Based New 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 New EUGMP USFDA PICS WHO Based New 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 New EUGMP USFDA PICS WHO Based New Project to subsequently be fully engineered with changes mitigated. Capital investment costs will be further refined to provide more accurate New EUGMP USFDA PICS WHO Based New Project cost estimates.

Detailed engineering

Our detailed design package provides over 500 items – including all the drawings, specifications and documentation needed to progress the New EUGMP USFDA PICS WHO Based New 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 New EUGMP USFDA PICS WHO Based New Project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, PV to Validation report writing.