Value Engineering And GMP Turnkey Services
SPM provides high added-value solutions in consultancy, engineering and construction of pharmaceutical plants and complete laboratories for the manufacture of medicines, including critical equipment. This encompasses validation, regulatory compliance and implementation services for logistics management and maintenance systems.
You’ll Benefit From:
- Customized approach - solutions to fit your situation
- Joint problem/opportunity definition
- Collaborative problem solving
- Fact-based decisions and actionable recommendations
- Ownership of final decisions and action plans
Our Turnkey Process
SPM has a team of consultants with extensive professional experience in the production departments, quality, engineering, research, and pharmaceutical industries records.
From the initial concept starting with an idea, to the final approval by national and international regulators, we will guide you safely in the whole process.
SPM engineering capabilities comprise of proven processes and best practices which guarantee Quality by Design implementation from the outset and looks to provide integrated design, construction and GMP compliance.
When it comes to designing and building custom pharmaceutical machinery, you need a supplier Engineering Design with broad capabilities, experience.
SPM start the project execution from the machinery manufacturing based on the machinery design settled in the engineering design step. After the shipment, workers will arrive onsite for cleanroom, machinery, and auxiliary facilities setup.
Project Management & Validation
During the project validation & qualification, our specialized technicians develop protocols, calibrate, and validate according to ISO, FDA & EMEA GMP, GLP standards and national/international regulations.
How We Do It?
With 20 years of pharmaceutical field studies, SPM has substantial experience in executing pharma projects from conceptualization to validation while focusing on an economical solution. SPM takes on overall management of customized, integrated, innovative, and effective turnkey projects, including consultancy, development, and end-to-end monitoring of projects.
We Carry Out A Turnkey Project Through:
- Conceptual Design and Basic Engineering
- Detailed Engineering
- Equipment Manufacturing
- Shipment and Installation
- Project Management
- Site Acceptance Test & Commissioning
- Standard & Validation Documentation (IQ/OQ/PQ Protocols)
- Plant Start up
- Regulatory Support