The projects execution is managed by projects manager, process engineers and designers. They are involved earlier in the project to define or review the scope of work, specific audits, URS development, management of FAT & SAT tests, engineering documents, deliverables & validation project management through traceability matrix.
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.
PROJECT EXECUTION & VALIDATION
APRO-TECH deals with clean room architecture and auxiliary equipment, system of air treatment engineering, clean fluids, industrial facilities, control, construction and assembly of the clean rooms installation.
APRO-TECH offers personalized project management focused on time and budget.
Every pharmaceutical project is unique and each project requires a detailed project execution plan. For that, we offer to our clients a customized project execution plan following this diagram
APRO-TECH performs the execution of the project through the development of an implementation planning and adjusted quantitative slip to the reality of each installation and sub project.
APRO-TECH has a solid experience, technical knowledge and a multidisciplinary team contributing to customized solutions according to international standards. APRO-TECH’s team is in charge of:
. Design review & PID's review
. Preparation of the construction layout
. Planning and scheduling
. Listing technical documentation & Data sheets
. Materials procurement & Selection of equipment
. Industrial Safety Health Environment -SHE-
The purchasing strategies elaborated by APRO-TECH for each project, create great value during the project’s execution. We offer to our clients:
· Specification of materials and equipment according to ongoing project needs
· Technical and detailed list of equipment and components
· Purchases follow-up
· Best quality materials and the most advanced technology and equipment
APRO-TECH is a specialist in clean rooms installation and critical areas:
• Clean Rooms Installation and assembly
• HVAC Installation and assembly
• MEP Installation
• Industrial Electrical Installation & Control
• Mechanical Facilities and Firefighting Systems
• Process Equipment Installation and Commissioning and Special Services
Project management is one of the principal steps for Successful Project Execution, during the life cycle of the project; APRO-TECH manages:
- Time, cost, quality, change, risk mitigation, issue, procurement and comunications
- Coordination and direction of local contractors
- Acceptance and documents
- Update and approval of all the facility, cleanrooms and equipment drawings and documentations “As Built“.
VALIDATION & QUALIFICATION
APRO-TECH has a highly qualified team of technicians experienced in qualification process DQ, IQ, OQ, PQ following the validation master plan and applying the highest standards: ISO, GMP, GLP and FDA.