Gxpro offers comprehensive project consulting services for Greenfield and Brownfield projects. Our expertise lies in engineering concepts crucial to drug development, manufacturing, and distribution in the pharmaceutical industry. With a focus on Quality by Design (QbD) principles, we ensure quality is integrated into the entire development process.
we merge engineering expertise with Industrial VASTU, bringing harmony and balance to your pharmaceutical facilities, aligning them with natural forces and cosmic energies.
Our services encompass a range of stages:
- Feasibility Studies: Assess the viability of the project by conducting market research, analyzing regulatory requirements, evaluating the availability of resources, and considering financial implications.
- Site Selection: Help in identifying suitable locations for the pharmaceutical facility, considering factors such as infrastructure, proximity to suppliers and customers, transportation, and regulatory considerations.
- Facility Design and Layout: Assist in designing the layout of the manufacturing facility, considering factors like process flow, equipment requirements, compliance with regulatory standards, and optimization of space and resources.
- Design Risk Assessment: Identifying and mitigating potential hazards, contamination risks, and operational inefficiencies through thorough risk assessments.
- Detailed Engineering Design: Developing precise engineering drawings and specifications, including architectural, structural, mechanical, electrical, and plumbing plans.
- Regulatory Compliance: Ensure that the facility adheres to all applicable regulatory requirements, including WHO, FDA, EMA, environmental regulations, safety standards, and quality control measures.
- Project Management: Oversee the entire project, coordinating with architects, contractors, equipment suppliers, and other stakeholders to ensure timely execution and cost-effective implementation.
- Technology and Equipment Selection: Provide guidance on selecting the appropriate technology platforms, machinery, and equipment for various manufacturing processes, ensuring efficiency and compliance with industry standards.
- Commissioning and Qualification: Executing commissioning and qualification protocols to verify facility, utilities, and equipment adherence to GMP guidelines.
- Quality Assurance and Control: Develop quality management systems, standard operating procedures (SOPs), and protocols for quality assurance and control throughout the manufacturing process.
- Training and Capacity Building: Provide training programs for personnel to ensure they are well-equipped with the necessary knowledge and skills for efficient operations.
- Contractual Closeout: Formal sign-off acknowledging successful contract completion.
- Post Project Review: Addressing post-closeout actions, like transition activities or ongoing support commitments, based on contract nature.
- Supply Chain Management: Optimize the supply chain by streamlining procurement processes, managing inventory, and implementing efficient distribution and logistics systems.
- Financial Analysis and Business Planning: Assist in financial analysis, forecasting, and developing business plans to ensure the project's long-term profitability and sustainability.