What needs to be prepared when building a shelter?

We believe that the most important step in the construction of a factory is determining concept and basicplan. Analyzing the current situation and problems at the basic planning stage and clarifying the goals will lead to the success of all projects.
 

Period 1: Basic Planning

We clarify customer's problem and consider the concept of the factory and its future.

1.1. Issues and Needs

· Establishing new factory or facility

· Saving manpower by automation

· Renovating factory or facility

· Expanding production volume

· Needs to get stable operation

· Reinforcing water treatment and environment measures

· Reinforcing food defense measures

· Improving product quality

1.2. Solutions and Proposals

· Designing basic plan that reflect the needs

· Selecting production equipment

· Selecting and bridging construction company

· Considering energy-saving

· Supporting administrative applications

· Supporting trial operations

· Designing and overseeing

· Managing construction safety

· Managing budget

· Managing schedule

Period 2: Basic Design
 

We prepare documents for every aspect of the factory to share concept and image with the customer.

· Process machines and equipment

· Structure, architecture, external structure, utilities

· Production control

· Environmental facilities, etc.

· Solutions and proposals

· Material balance

· Construction budget

· Legal requirements

· Construction master schedule

Period 3: Detailed Design

We prepare detailed documents for application of construction work to be submitted to the administration.

· Formulating construction master schedule

· Acting as regulatory application agent

· Finalizing construction execution budget

· Preparing construction drawings

· Creating a factory start-up plan

· Preparing specifications for machine procurement

· Considering factory maintenances system

· Finalizing manufacturing layout

Period 4: Contracts and Orders

We place orders and sign contracts with suppliers after confirming and evaluating the contents of the quotes submitted by each supplier.

· Planning orders

· Comparing budgets

· Summarizing specification for quotation

· Confirming specifications

· Inquiring quotation

· Selecting suppliers to order

· Evaluating quotations

· Concluding contracts

Period 5: Fabrication and construction

We properly manage the construction period, quality, and safety of the work throughout the construction.

· Construction control

· Safety control

· Quality control

· Site control

· Budget control

· Design supervision

Period 6: Inspection and test operation

We receive inspection by public officials and also conduct test operations of the completed building.

· Planning inspections and test operation

· Compiling building documents

· Carrying out inspections

· Planning maintenance and after-sales service

· Preparing inspection results

· Accepting inspections and handing over work

· Supporting test operations

Period 7: Facility Handover

Period 8: Production operation

Before operating factory operations, businesses need to prepare documents in advance to operate effectively.

Documentation is the key to operating a pharmaceutical company in compliance with GMP requirements. The system of documentation devised or adopted should have as its main objective to establish, monitor, and record "quality" for all aspects of the production and quality control. Several types of documents are needed to accomplish this.

A. Standard operating procedures, specifications and master formulae
 

Descriptive documents give instructions on how to perform a procedure or a study, or give a description of specifications. The instruction type documents are: standard operating procedures (SOP); protocols (for validation studies, stability studies, safety studies); and master formulae (manufacturing instructions). Each of these gives instruction on how to perform specific procedures. Specifications describe the required characteristics or composition of a product or material or test. These kinds of documents provide the specific details defining the quality of incoming materials, the quality of the production environment, the quality of the production and control process, and the quality of the final product.

B. Forms for recording data

Another type of documentation is the form used for recording data as it is taken during the performance of tasks, tests, or events. These are forms (datasheets, or data

record forms), reports, batch processing records, and equipment log books. These documents provide the evidence that the raw materials, facility environment, the production process, and the final product consistently meet the established quality requirements.

C. Identification numbers

There are also the identification systems or codes devised to number and track both information and documents. These are SOP numbers, equipment numbers, form numbers, receiving codes, and batch/lot numbers. These numbering systems should be designed so that procedures, processes and materials can be traced throughout the data records.