Facility Construction｜Trial operation　-Commissioning & Qualification-

Home/ Services/ Engineering, Project Management/ Facility Construction/ Trial Operation -Commissioning & Qualification- Facility ConstructionTrial Operation-Commissioning & Qualification- Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Commissioning & Qualification and Validation Process Commissioning & Qualification represent the final stages in the trial operation phase. However, it is important to conduct checks at each stage from the initial design phase to maintain quality and ensure the project proceeds smoothly.   See the Flow of Facility Construction In a pharmaceutical factory…Validation (Commissioning & Qualification) According to the GMP ordinance, “Validation” is defined as “the action of verifying that the structure, equipment, and procedures of a manufacturing site, as well as the methods of manufacturing and quality control procedures, produce the expected results, and documenting this verification.” Achieving high-quality and efficient validation in new construction or renovation projects of pharmaceutical factories is one of the most important tasks to accomplish. Validation Support by CM Plus CM Plus possesses “Validation Management Technology,” which enables efficient validation through a consistent philosophy from the initial stages of the project. Flow of Validation Consulting See other phases Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Related Contents Projects Performance by Numbers Useful Information Please also refer to the articles on our information dissemination site, “GMP Platform.” Although the title contains “Pharmaceutical Factory Construction,” the content is applicable to the construction of factories in various industries, not limited to pharmaceutical factories. “How to Build a Pharmaceutical Plant” This article discusses how to minimize the burden of validation, which requires substantial time and cost in pharmaceutical factory construction projects, while achieving both GMP compliance and cost rationality in the deployment of qualification. We propose the concept of Lean Qualification. More details can be found...

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Validation Consulting

Home/ Services/ Consulting/ Validation Consulting ConsultingValidation Consulting Validation in Pharmaceutical Manufacturing Validation is defined as the following; "A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. (ICH Q7A)" "Establishing documented evidence which provides a high degree of a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.(FDA Process Validation Guidance 1987)" High-quality and efficient validation execution is one of the most important challenges to be achieved in new construction or renovation projects of pharmaceutical factories. Recently, the pharmaceutical industry has been transitioning from traditional validation to “science and risk-based validation.” This transition requires the implementation of risk assessments and the creation of validation plans based on these assessments, increasing the effort required for validation. CM Plus offers services tailored to customer needs, ranging from support for creating validation master plans and risk assessments, to preparing and executing protocols for qualifications (DQ, IQ, OQ, PQ) from the planning stage. This helps reduce the burden on customers. Additionally, we can accommodate requests for validation tasks alone, separate from planning and design tasks. We are flexible in responding to customers who are already in the construction phase, so please feel free to consult us. Feel free to contact us regarding validation. Contact Form The Flow of Validation in a Project Preparing the Validation Master Plan The Validation Master Plan (VMP) is a comprehensive validation plan compiled for a pharmaceutical plant construction project. It typically documents the following items, tailored to the project content: Validation policy Organizational structure for validation activities Systems subject to validation (facility, equipment, machinery, etc.) Overview of manufacturing processes Formats for various protocols and reports Validation schedule Change control and deviation management...

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Education/Training Support

Home/ Services/ Education/Training Support ServicesEducation/Training Support We provide education that encourages thinking “why,” not just acquiring knowledge. In the manufacturing and sale of pharmaceuticals and other products, it is essential to comply with various regulations, starting with the Pharmaceutical and Medical Device Act. Moreover, as these products directly affect human and animal lives and health, there is a social mission and responsibility to maintain proper quality while ensuring a stable supply. Therefore, it is required for companies to plan and implement education and training programs for all employees that include mandatory GMP training, compliance, morality, and the ability to think and make judgments. Our education and training support services based on the “GMP Platform,” provide educational content focused on quality (manufacturing). Additionally, we offer education and training support programs that bring together various information and the expertise of our experienced consultants. Through those services, CM Plus assist in solving our clients' issues from the perspectives of both the quality system and the education system. Features of CM Plus Education/Training Support Aggregate of "knowledge", which keeps sharing the latest information On "GMP Platform" (https://www.gmp-platform.com/en/), CM Plus's web service, you can read the latest information and regulations in life science industries, and serial articles. GMP Platform By registering for a free membership, you will be able to access the published information. You can gather information from a series of articles and news topics related to GMDP/QMS. GMP Platform You can learn at any time and as much as you need CM Plus offers eLearning courses which you can use at any time and any place such as open seminars held at a venue or on-site seminars held at our client's office. We offer tailor-made educational programs for companies which are too busy to develop and carry out their own programs. CM Plus's...

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Terumo Yamaguchi Corporation

Home/ Portfolio/ Projects/ Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation DATA Function Medical device manufacturing facility Overview (Total floor area) approx. 51,700㎡, 5 floors Location Yamaguchi City, Yamaguchi Prefecture PREV NEXT 1 / 3 Services we provided 1.Helping create the URB (User Requirement Brief) 2.Basic planning 3.Basic design 4.Validation planning 5.Helping select the construction company 6.Detailed design supervision 7.Construction supervision 8.Validation support Project flow Approx.7 months Basic Plan/ Basic Design Preparation for Inquiry Approx.4 months Construction Inquiry Approx.6 months Detailed Design Approx.16.5 months Construction Our contributions to the project We summarized the planned production volume, manufacturing environmental standards, necessary utility conditions, requirements for facilities and equipment in accordance with the Pharmaceutical and Medical Device Act/QMS Ministerial Ordinance 21CFR Part 820 (QSR) and MDR as a URB. During basic planning, we discussed automating logistics within the building as well as coordination with the existing building. According to the operation of each process, we figure out the material flow and personnel flow, environmental standards, and changing systems, and discussed layout plans and cross-sectional plans tailored to the level of automation. During basic design stage, in addition to the basic design, we created a validation plan to clarify the requirements for the contract. To build an optimal logistics system complying with smart factories/Industry 4.0, we investigated the latest information and arranged tours to the latest facilities at the beginning of the basic plan. Furthermore, we reviewed the technical proposals and estimates from each logistics equipment manufacturer, coordinated with the construction company, and supported direct ordering to logistics equipment manufacturers. To ensure a smooth project progress, we provided a rough estimate when the basic planning and basic design were completed to help the client's budget making. At the construction inquiry...

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CoreTissue BioEngineering Inc.

Home/ Portfolio/ Projects/ CoreTissue BioEngineering Inc. Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. DATA Function Medical devices manufacturing facility complying with QMS Overview Total floor area approx. 420㎡ Location Yokohama City, Kanagawa Prefecture PREV NEXT 1 / 3 Services we provided 1.Helping create the URB (User Requirement Brief) 2.Selecting candidate site 3.Conceptual design 4.Preparing basic plan and construction inquiry document 5.Helping select construction contractor 6.Basic/detailed design management 7.Construction supervision 8.Validation support Project flow Approx.5 months Candidate sites selectingURB creatingConceptual Design Approx.3 months Basic PlanInquiry SpecificationsCreating Approx.2 months Construction Inquiry Approx.9 months Basic Design/Detailed Design/Construction Our contributions to the project We summarized the planned product (Artificial Ligament used for ACL reconstruction) production volume, necessary utility conditions on production equipment and analysis apparatus, requirements on facilities and equipment as a URB (User Requirement Summary). When selecting the candidate site for relocation, we provide advice on expected size, infrastructure based on URB from an engineering perspective, and finally work with the customer on selecting the candidate site considering the occupancy conditions, conditions on construction contracting, etc. At the conceptual design stage, we discussed the floor layout, material/personnel flow and equipment system with consideration to expansion from clinical trial stage to commercial production. To realize the concept of this project “Medical device facility complying with QMS”, we have adopted the thinking on GMP-compliant facilities. Specifically, these include clear and step-by-step area zoning and air conditioning systems, room pressure control, environmental monitoring, uninterrupted power outage measures, and insect control, like those used in pharmaceutical facilities. To proceed with the project accurately, we provided a rough estimate so as to help the customer in creating a budget. At the construction inquiry stage, we created detailed specifications for inquiries. This makes it possible to make inquiries to multiple...

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Terumo Vietnam

Home/ Portfolio/ Projects/ Terumo Vietnam Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facilities that are safe and environmentally friendly for people and communities Terumo Vietnam Co., Ltd DATA Facility Use Medical device manufacturing facility Summary (Total floor area): More than 30,000㎡ including renovation for existing facility Location Hanoi, Vietnam PREV NEXT 1 / 3 Services we provided 1.Support for preparation of URB (User Requirements Brief) 2.Basic planning 3.Basic design 4.Validation planning 5.Construction company decision support 6.Detailed Design supervision 7.Construction supervision 8.Validation support Project flow Approx. 6 months Basic Plan /Basic DesignInquiry Preparation Approx. 4 months Inquiry for construction quotation Approx. 7 months Detailed Design Approx. 18 months Construction Our contributions to the project Documented required utility conditions, and requirements for facilities and equipment as URB in accordance with the expected product production volume, manufacturing environmental standards, Vietnamese national regulations, Chinese medical device regulations, MDR, 21CFRPart820 (QSR), and the Pharmaceutical Affairs Law. In the basic plan, we organized the flow lines of people and goods, environmental standards, and changing systems, and studied the floor plan and cross-sectional plans, including plans for existing renovations according to the manufacturing operations in each process, We completed the basic design with a structural plan and material selection that matched the actual conditions of the construction site (Vietnam). At the construction inquiry stage, we prepared specifications for quotation inquiries, design documents, and requirement specifications for validation with clear specifications. This made it possible to conduct quotations for multiple companies and to evaluate quotations fairly. During the detailed design and construction phase, our CM and four Vietnamese engineers were stationed at the site to supervise the construction work, including checking the construction progress, checking construction quality, confirming changes, and assessing additional construction costs, thereby contributing to ensuring good construction quality. Smooth start-up of production facilities was...

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Medreich Limited

Home/ Portfolio/ Projects/ Medreich Limited Pharmaceuticals and Medical Devices Pharmaceutical manufacturing factory: Expansion for manufacturing line Medreich LimitedMeiji Seika Pharma Co., Ltd. Group DATA Facility Pharmaceutical manufacturing factory Location Bangalore, India PREV NEXT 1 / 3 Services we provided The following services were provided as engineering consulting 1.Conceptual Design (Engineering Management services) 2.Contractor selection support (Project Management services) 3.Detailed Design Management (Project Management services) 4.Construction Supervision (Construction Management services) 5.Validation support (Validation Management services) Project flow Approx. 4 months Prepare Conceptual design/ Contract documents 2 months EPC company’s basic design Approx. 3 months EPC company’s detailed design phase 6 months Construction phase Our contributions to the project CMP’s Japanese – English bilingual members participated Prepared documents for concluding a contract with the design and construction company. Reviewed the detailed design of the design and construction company. Two Japanese staff and two Indian staff were stationed at the site to supervise construction and validation, and the project was completed within the scheduled period. Checked the completion of the Validation Final Report and ensured that the necessary documents were in place. Services related to this project Engineering, Project Management Other Projects Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting Jitsubo CO., LTD. Pharmaceuticals and Medical Devices／Packaging Aiming to create a factory that "responds to rapidly changing customer demands and stay ahead of the competition for 15 years" Iwata Label Co., Ltd.(currently IL Pharma Packaging Co., Ltd.) Cosmetics “Show” cosmetics factory Toyo Beauty Co., Ltd. Data Centers System module type data centerRealizing short construction period and low cost Internet Initiative Japan Inc. Pharmaceuticals and Medical Devices Large-scale...

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Consultants

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