Project management - Construction supervision
04/05/2023 | 805
Project Management Consultancy - Construction supervision and installation of technological equipment
"Ensure Quality, Progress, Cost, Construction Safety in accordance with the design documents in parallel with the preparation of IQ, OQ, PQ Documents"
The general characteristics of an investment project to build facilities (Factory, Equipment) according to EU GMP principles and standards is that it includes many items, in which each item is "highly specialized" such as :
- Workshop: Ensure to minimize the possibility of infection, cross-contamination, easy to clean, prevent outside intrusion (dust, insects, ....)
- HVAC system with requirements: Temperature, Humidity, Pressure, Air exchange frequency, Cleanliness
- RO water system/Distilled water/wastewater treatment: Comply with GMP, Pharmacopoeia, specific requirements of Products during production and Testing,...
- Pneumatic, Vapor, ...: Suitable for the characteristics and use needs of production and products,...
Therefore, the Management - Supervision of construction and installation of technological equipment requires the Consultant to clearly understand the Purpose of Use, the requirements for the Workshop, Ancillary Equipment, .. . Only then can we ensure quality, cost, schedule, safety and other issues during the construction of the Project.
Not only that, the process of installing machinery and equipment needs to be "done in parallel" with the preparation and completion of the document system (IQ, OQ, PQ, SOP, ...) for the Equipment System, helping for the Plant's technical staff to both master the Equipment System and ly complete the GMP Assessment Dossier soon after the construction process is completed.
"GMPc Vietnam cooperates with Inotek Pharma Solutions to provide the consulting service Building a Professional, Efficient EU GMP Factory, Ensuring the operating equipment system with a Pro that meets the requirements of EU GMP".
