A+ Solution
For GMP Compliance
Request for Quotation
For GMP Compliance
Scroll Down
Scroll Down
Our organization is comprised of seasoned professionals who possess various experiences and
working-level knowledge from multi-national pharmaceutical companies in home and abroad.
Using our on-site experiences, we work together with the clients to solve the problem.
To provide the best quality and service, we have formed a consortium with world-renowned companies, and we are providing consulting services tailored to meet the Needs of our customers.
Beginning with the concept design to the assessment of the
detailed designs, we provide overall service that incorporates GMP
Construction On-site Supervision, SOP Development, Qualification and
Validation and assistance for GMP approval.
We conduct a Feasibility Study that assesses the validity of the factory’s site by evaluating the government's environmental and structural regulations. Furthermore, the assessmentincludes technological research, market research, investment costs and operating costs, etc.
Concept & Basic Design embodies designing efficient flows and workplace configurations to ensure product's effectiveness, safety and stability. These are materialized through an analysis of the process requirements within GMP regulations and risk assessment which minimizes contamination risk and at the same time, optimizing the processes.
Furthermore, the objective of the design is to make the best use of the space and thereby the operating cost by taking into the consideration of the new Pipe Lines and CompanyRequirements
We provide Qualification (URS, RA, DQ, FAT, SAT, IQ, OQ, PQ) for Production Equipment an Utilities by reflecting the QRM (Quality Risk Management), DI (Data Integrity) and CCS (Contamination Control Strategy) based on our extensive experience, practical knowledge and ability (know-hows).
We are providing the overall Qualification & Validation service to our clients, beginning with Validation Master Plan (Including the System Impact Assessment and System Risk Assessment) and PV, CV, CSV, MV and TV.
We assist the establishment of an effective QMS (Quality Management System) by conducting the Gap Analysis and forming a new document system (Quality Manual, SOPs and Templates) that reflects the up-to-date GMP regulations such as the QRM (Quality Risk Management), DI (Data Integrity) and CCS (Contamination Control Strategy).
For a successful audit of our clients, we provide a variety of Audit Support such as the mock audit, 3rd party audit and audit support based on our various audit experiences.
We provide a GMP Training that includes the up-to-date GMP regulation and base our clients’ requests, we provide tailored practical training after discussing on the topic and target audience of the training.
After requesting calibration to a KOLAS-certified company, we provide calibration reports, establish a systematic maintenance plan and support system operations to lower the failure rate of factory facilities and increase facility operation through the implementation and management of the plan.
We receive A/S training from the manufacturing company to provide the best maintenance services by supporting a quick repair of the malfunctioning devices when in need.
We deliver qualified equipment that satisfies the GMP regulation. Also, we provide services
for the equipment such as Calibration, Maintenance, Qualification, and Training.
Please inquire about a quote from sureAssist Co.,Ltd.
