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. In addition to equipment diagnostics that comply with GMP and regulations, we provide support for preparations for various inspections, as well as measures and improvement proposals for issues raised. We can assist with tasks such as "preliminary equipment diagnostics" and "measures and improvement proposals for raised issues." We can also provide specific advice on how to respond to detailed points and requests, as well as how to explain them, so please feel free to consult with us. [Examples of services we can provide] ■ Preliminary equipment diagnostics ■ Advice on explanation methods (anticipated Q&A) ■ Preliminary responses to potential issues ■ Measures and improvement proposals for raised 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 of 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 part 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 selection criteria for measurement locations of "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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Our company supports you in smoothly making changes and considerations not only for the items you have produced so far but also for new items you 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 I am concerned about the feasibility with only my company's resources and 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 is close to 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 machines handling different products are installed in the same manufacturing room"? Our experienced engineers will carefully identify issues by conducting on-site surveys and interviewing operators about your current situation. We will share the identified issues with you as challenges and decide on a course of action for proposed solutions. 【Do you have any of the following challenges?】 ■ There have been observations 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 start with the minimum necessary 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 group training. 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 training. We have a base curriculum prepared, but we will flexibly customize it according to the themes you want to emphasize, the challenges within the organization or facility, and the experience and number of participants. 【Do you have any of the following challenges?】 ■ Want to conduct highly effective educational training ■ Want to incorporate third-party opinions on the educational programs you have implemented so far ■ Being asked by management to address safety and compliance issues ■ Although you have been conducting training in accordance with GMP regulations, you feel uncertain about whether it is truly being 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 related to "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 opportunities related to 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?】 ■ Do you want to create an environment where you can casually ask about various worries that you can't ask now? ■ Do you want a partner to consult with regarding various challenges that arise in daily operations and tasks that need to be addressed? ■ Do you want to identify potential challenges and opportunities related to the overall situation of the facility? ■ Are you overwhelmed by immediate tasks, making it difficult to plan long-term or focus on education? *For more details, please refer to the PDF document or feel free to contact us.

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We conduct health assessments of our customers' pharmaceutical manufacturing facilities. We perform GMP equipment diagnostics, extract inherent issues from the current situation, 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 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 facility complies with PIC/S GMP and identify areas that need to be addressed. ■ You are unsure about what specific changes need to be made to satisfy inspectors, and while you want to take necessary actions, you wish to keep costs as low as possible. *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 regenerative medicine product manufacturing facility by renovating existing facilities? ■ If so, what kind of renovation work would be necessary? ■ Is the construction of a regenerative medicine product manufacturing facility 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, conception, and execution aimed at increasing production volume in pharmaceutical manufacturing facilities. There are actually multiple approaches to increasing production volume, 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 utilize new spaces. - 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 materials or feel free to contact us.*

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We support our customers in constructing new factories, renovating or rebuilding existing ones, in line with their future visions. While sharing the unique characteristics of each customer's factory, the current situation, potential and existing challenges, management policies, and medium- to long-term plans, we will assist in building pharmaceutical manufacturing facilities that comply with GMP-related regulations, considering not only productivity but also workability in maintenance and preservation, from a practical perspective. 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 led to inefficiencies in the factory layout ■ We want to advance 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 facility diagnostics that "visualize" equipment risks. Please feel free to contact us if you have any requests. 【Service Contents】 ■ GMP Facility Diagnostics ■ Measures and improvement proposals for each inspection finding ■ 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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