We grasp the customer's GMP situation by GAP analysis and understanding of hearing from clients, so that we extract the current client’s problem. GAP analysis will make a difference between the current situation and the GMP requirements at the 3 stations level before PMDA and FDA inspection, and will make necessary improvement suggestions according to your request. We will propose several solutions based on the latest GMP requirements for that subject.
1.Validation Consulting
- Support for creating IQ, OQ, PQ document in an existing facility
- Support for creating URS, Master Plan, and Qualification document. We also conduct to review these document.
- Process Validation for Drug and API
- Analytical Validation for Drug and API
- Cleaning Validation for Drug and API
2.SOP Consulting
- Support for reexamining SOPs by GAP analysis based on various laws, regulations and ICH guidelines
- Support for creating the GMP SOPs who starts pharmaceuticals business.
- Support for creating the Clinical GMP SOPs.
3.Training
We will build an educational program that suits the actual situation with clients, we will conduct this training instead of our clinets. The degree of comprehension can be figured out by tests which is created by us. We provide tailored training programs for any experience and responsibility level.
- Training for the manufacturing process responsibility
- Training for the GMP beginners
- Training for the introduction of clinical GMP
- Training for FDA inspection
- Training for GMP audit trainer
4.Facility Renovation & Expansion
- We provide proposals for appropriate facility and/or equipment installations which meets the latest GMP and customer requirements.
- We perform construction management on behalf of customers.
- We provide support for the production facility maintenance plans or introduce our partners company with maintenance specialist.
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5.CSV Consulting
- We support clients not only an existing CSV system but quality control system.
- We provide feasible and realizable proposals that they can be constructed and operated from spreadsheet to DCS.
- We advise on installing a new system or on installed system such as DCS, MES and DMS (Document Management System).
6.DI Consulting
- Assess GAP accurately between customer’s current status and requirements based on the latest DI guideline and provide feasible and realizable proposals to client.
- Support for establishing the data governance from a comprehensive GXP perspective
Others services