Provision of Engineering Solutions for the Pharmaceutical and Biotechnology Industries
Nova Pharma Solutions provides total engineering solutions ranging from Pre-Design (Feasibility Study, Site Selection, Assist in Technology Transfer) to Design (Conceptual Design, Basic Design and Detailed Design) to Post-Design (Tendering, Procurement and Site Supervision) to other Supporting Activities (GMP Documents Review and Gap Analysis & Assessment).
PRE-DESIGN
Analysis and evaluation of the project feasibility is carried out from commercial and technical perspectives to discover the solution that best fit the clients’ business. This provides a broader picture for our clients, including assessments on the required investment. The following depicts the four key elements for evaluation:
- Investment Estimates
- Manufacturing Cost Analysis
- Tax and Depreciations
- Time from Conceptual Design to Operation
- Realistic Detailed Design and Construction Time
- Safety and Local GMP Business Environment
- Workforce Flexibility
- Infrastructure
- Overall Risks
Pre-design may also involve technology and process know-how sourcing where we will assist our clients to establish strategic partnerships with suitable service providers.
DESIGN
Conceptual Design is the first stage of the design process and is a design execution that supports clients’ decision process and creates a clear picture of the task for the next project phase. This stage is carried out based on the feasibility study in pre-design stage. During the initial stage, a One Page Strategy that contains the project mission, objectives, strategies, key assumptions and focus area will be developed to enable both our client and us to have the same understanding on the project.
DESIGN
Conceptual Design is the first stage of the design process and is a design execution that supports clients’ decision process and creates a clear picture of the task for the next project phase. This stage is carried out based on the feasibility study in pre-design stage. During the initial stage, a One Page Strategy that contains the project mission, objectives, strategies, key assumptions and focus area will be developed to enable both our client and us to have the same understanding on the project.
POST-DESIGN
Post-Design primarily commences with the contract set-up stage involving tendering and procurement process. This stage also involves the construction of the plant, where our roles vary according to the types of contracts, including site supervision and construction management.
OTHER SUPPORT
Other Support services include assisting customers in the GMP documents review as well as gap analysis and assessment. As documentation is an essential part of the Quality Assurance System for a GMP-compliant client, reviews shall be performed regularly to ensure the documented information is correct and accurate. Gap analysis & assessment is a process to identify the requirements to close the gap between current level of performance utilizing existing resource allocations and its potential performance based on optimum allocation and integration of resources.
Assisting our clients in carrying out third party validation, commissioning and qualification to comply with required standards such as GMP can also be performed. Examples of validation include:
- Equipment is received and installed as designed and specified
- Equipment will function according to its operational specification in the selected environment
- Equipment consistently performs according to a specification appropriate to its routine use
Apart from the above services, we are also experienced in analysing upgrade needs of a pharmaceutical/biotechnology plant and defining the revamp scope for the production. For pharmaceutical/biotechnology plants that intend to cease operations, we can assist clients in planning the sequence of shutting down to ensure a smooth transition.
OTHER SUPPORT
Other Support services include assisting customers in the GMP documents review as well as gap analysis and assessment. As documentation is an essential part of the Quality Assurance System for a GMP-compliant client, reviews shall be performed regularly to ensure the documented information is correct and accurate. Gap analysis & assessment is a process to identify the requirements to close the gap between current level of performance utilizing existing resource allocations and its potential performance based on optimum allocation and integration of resources.
Assisting our clients in carrying out third party validation, commissioning and qualification to comply with required standards such as GMP can also be performed. Examples of validation include:
- Equipment is received and installed as designed and specified
- Equipment will function according to its operational specification in the selected environment
- Equipment consistently performs according to a specification appropriate to its routine use
Apart from the above services, we are also experienced in analysing upgrade needs of a pharmaceutical/biotechnology plant and defining the revamp scope for the production. For pharmaceutical/biotechnology plants that intend to cease operations, we can assist clients in planning the sequence of shutting down to ensure a smooth transition.
TURNKEY
Nova Pharma Solutions provides total engineering solution through Turnkey service. We will take full responsibility of the project from pre-design to commissioning of the plant. This will involve overall management of the construction site, coordination with client and contractor, coordination with authorities and complying with local environment requirements.
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