平原エンジニアリングサービス List of Products and Services

Our company has been deeply involved in the construction and operation of pharmaceutical manufacturing facilities for many years. We provide support for equipment diagnostics that comply with GMP and regulations, as well as assistance in preparing for inspections, addressing identified issues, and proposing improvements. We can assist with tasks such as "preliminary equipment diagnostics" and "measures and improvement proposals for identified issues." We can also provide specific advice on how to address detailed points and requests, as well as methods of explanation, so please feel free to consult with us. [Examples of services we can provide] ■ Preliminary equipment diagnostics ■ Advice on methods of explanation (anticipated Q&A) ■ Preliminary responses to potential issues ■ Measures and improvement proposals for identified issues *For more details, please refer to the PDF document or feel free to contact us.

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Temperature mapping is an initiative to measure the temperature distribution in storage spaces in three dimensions, in order to meet the "temperature standards," which is one of the storage conditions for each pharmaceutical product. Are there any challenges such as "I can't distinguish between mapping and monitoring, so I would like a clear explanation from the basics" or "I would like to outsource some of the operations related to temperature mapping and year-round efforts to an external vendor with expertise"? Our company provides support from planning to implementation of temperature mapping. We will consider the most suitable approach for each customer, so please feel free to contact us. 【Features】 - Support from planning to implementation of temperature mapping - Guidance on the rationale for selecting measurement locations for "representative points," "hot points," and "cold points" for continuous monitoring - Assistance in creating temperature mapping plans/reports - At a level that can respond to inspections from clients and authorities - Providing know-how on "temperature management" required in the pharmaceutical distribution field *For more details, please refer to the PDF materials or feel free to contact us.

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We support our customers in smoothly making changes and considerations not only for the items they have produced so far but also for new items they wish to produce. Do you have any challenges such as "I want to establish a production system for the possibility of accepting new items" or "I want to make effective use of the vacant space on the premises"? When it comes to increasing the number of items, there are various aspects to consider. Our company can handle a wide range of cases, so please feel free to contact us for an initial inquiry. 【Do you have any of the following challenges?】 ■ I want to establish a production system for the possibility of accepting new items. ■ I want to make effective use of the vacant space on the premises. ■ I want to handle new generic pharmaceuticals but feel uncertain about considering it with only my company's resources, so I would like support. *For more details, please refer to the PDF document or feel free to contact us.

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We will support you in preventing "cross-contamination" at your pharmaceutical manufacturing facility from a position that aligns with your company. Are there any issues such as "the same staff member is responsible for both weighing tasks and the manufacturing of different products" or "multiple production equipment for different products are installed in the same manufacturing room"? Our experienced engineers will carefully identify the issues by conducting on-site investigations and interviewing workers about your current situation. We will share the identified issues with you as challenges and decide on a course of action for solutions. 【Do you have any such challenges?】 ■ There have been comments related to cross-contamination during inspections, and upper management is urging consideration of countermeasures. ■ You would like to receive support from knowledgeable and experienced experts regarding the current evaluation of cross-contamination and future enhancements. ■ You want to implement necessary minimum measures while keeping the budget in check. *For more details, please refer to the PDF document or feel free to contact us.

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We offer an "educational training menu" based on your facility in the form of on-site seminars for GMP collective education. We conduct educational training using your facility as a subject. This reduces the risk of the training itself becoming the goal and maximizes the significance and intrinsic value of the educational training. We have a base curriculum prepared, but we will flexibly customize it according to the themes to focus on, the challenges within the organization or facility, and the experience and number of participants. 【Do you have any of the following challenges?】 ■ We want to conduct highly effective educational training. ■ We would like to incorporate third-party opinions on the educational programs we have implemented so far. ■ The management is requesting measures regarding safety and compliance. ■ Although we have been conducting educational training in accordance with GMP regulations, we feel uncertain about whether it is being effectively absorbed at the employee awareness level. *For more details, please refer to the PDF document or feel free to contact us.

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We support the extraction of issues from "troubled systems" and "concerning systems," as well as the consideration of solutions. "Do you want to create an environment where you can casually ask about various worries that you can't ask now?" "Are there any issues regarding the identification of potential challenges and possibilities concerning the overall situation of the facility?" We will conduct a 'System Review' to understand the current situation, extract inherent issues, and propose future improvement measures from the customer's perspective. 【Do you have any of the following issues?】 ■ Want to create an environment where you can casually ask about various worries that you can't ask now ■ Looking for a partner to consult about various challenges arising in daily operations and tasks that need to be addressed ■ Want to identify potential challenges and possibilities regarding the overall situation of the facility ■ Being overwhelmed by immediate tasks, unable to focus on long-term planning or education *For more details, please refer to the PDF document or feel free to contact us.

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Our company conducts health assessments of your pharmaceutical manufacturing facilities. We perform GMP equipment diagnostics to understand the current situation, extract inherent issues, and propose future improvement measures from the customer's perspective. We verify the current status of existing facilities, work conditions, validation, and related documents, bringing vague problems to light along with their underlying reasons. We will propose feasible countermeasures based on their importance, urgency, and investment costs, along with a plan for implementation. 【Do you have any of the following issues?】 ■ Manufacturing is currently running smoothly, but as the time for renewing the pharmaceutical manufacturing license approaches, you want to clarify how well your facilities comply with PIC/S GMP and identify areas that need attention. ■ You are unsure of what specific changes to make to satisfy inspectors. Additionally, you want to take necessary actions while keeping costs to a minimum. *For more details, please refer to the PDF document or feel free to contact us.

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We support the construction and renovation of pharmaceutical manufacturing facilities related to "regenerative medicine products." Do you have any questions such as: "What requirements must be met to manufacture regenerative medicine products?" "What practical measures should be taken to produce sterile preparations?" We will assist you from the first step of creating the "required facilities" for continuous pharmaceutical production, tailored to your unique needs. 【Do you have any of the following concerns?】 ■ What requirements must be met to manufacture regenerative medicine products? ■ What practical measures should be taken to produce sterile preparations? ■ Is it possible to establish a manufacturing facility for regenerative medicine products by renovating existing facilities? ■ If so, what kind of renovation work would be necessary? ■ Is building a manufacturing facility for regenerative medicine products worth the investment? *For more details, please refer to the PDF document or feel free to contact us.

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Our company supports the planning, conceptualization, and execution aimed at increasing production volume in pharmaceutical manufacturing facilities. To increase production volume, there are actually multiple approaches, and it is necessary to clearly organize which pattern the company wants to pursue and what initiatives to undertake. Experienced engineers carefully extract issues by conducting on-site investigations and interviewing workers about the current situation. We share the identified issues with the client and decide on the direction for solutions. **Approaches to Increase Production Volume** - Aim for a more substantial increase in production volume by constructing, expanding, or renovating the factory itself. - Remove unused machinery and make use of the newly available space. - Enhance the capabilities of machinery to aim for increased production volume. - Improve yield to aim for increased production volume. - Review warehouse and handling methods to aim for increased production capacity. *For more details, please refer to the PDF document or feel free to contact us.*

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We support our customers in the construction of new factories, as well as the renovation and rebuilding of existing factories, in line with their future visions. We share the current status of each customer's unique factory, the potential and existing challenges, management policies, and medium- to long-term plans, while considering not only productivity but also workability in maintenance and preservation. We provide on-site support for the construction of pharmaceutical manufacturing facilities that comply with GMP-related regulations. Please feel free to contact us for an initial inquiry. 【Do you have any of the following challenges?】 ■ Repeated expansions have filled the site ■ There are no engineers or vendors who can plan with a long-term perspective ■ Repeated expansions as needed have resulted in inefficiencies in the factory layout ■ We want to proceed with a limited investment plan based on a site plan that looks to the future ■ The aging of existing facilities is progressing, making it difficult to respond to inspection findings *For more details, please refer to the PDF document or feel free to contact us.

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Our company provides consulting services for pharmaceutical manufacturing facilities. We support users in improving productivity and risk management through validation management that reduces the burden on your operations and GMP equipment diagnostics that make equipment risks "visible." Please feel free to contact us if you have any requests. 【Service Contents】 ■ GMP Equipment Diagnostics ■ Countermeasures and improvement proposals for inspection findings ■ Basic concept and basic planning services ■ Support for the creation of validation documents *For more details, please download the PDF or contact us.

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