Categories

GMP

• GMP
  GMP WATCH NEWS – A Veteran’s Perspective［3］ Paradigm Shifts in Pharmaceutical Quality Systems A Historical Review and Future Perspectives [Part 3] From QC to the Pharmaceutical Quality System (PQS) When GMP was first introduced in 1963, the “testing” conducted by the QC department played a central role. However, as GMP evolved, there was a dramatic increase in complex tasks beyond testing, such as document control, change control, and deviation management. Consequently, the FDA revised CGMP in 1978, significantly strengthening the authority of the QC department. It clarified the department’s independence from the manufacturing department and its final authority over release decisions, effectively mandating that the QC department...
• GMP
  Fundamentals of Microbiology [Part 6] What Are Bacteria 2-1 Bacteria are representative of microorganisms, and the term is widely known, but only few people may explain them clearly. Living organisms are made of cells. Note) Cells are roughly divided into two types. Simply put, they can be called "lower organisms" and "higher organisms", but they are prokaryotic cells without a cell nucleus and eukaryotic cells with intracellular structures such as a cell nucleus or mitochondria. Bacteria are representative of these lower prokaryotic cells. Incidentally, eukaryotic cells are cells of animals, plants, fungi, etc., and are considered higher organisms than prokaryotic cells. Note) All living organisms...
• GMP
  GMP WATCH NEWS – A Veteran’s Perspective［2］ Paradigm Shifts in Pharmaceutical Quality Systems A Historical Review and Future Perspectives [Part 2] Implementation of Process Validation The concept of validation has its roots in the space technology developed during the U.S. Apollo program (1960s). Launch rockets are single-use. The concept of sampling inspection—where one might say, “Let’s test-launch it; since it worked, we’ll launch it again”—simply does not apply. Therefore, NASA rigorously applied the principles of reliability engineering—the idea that “if the design and manufacturing processes are flawless, the final product must also be flawless”—and established the prototype for the concept of validation. FDA officials wondered, “Why isn’t...

Halal

• Halal
  Schedule for Mandatory Halal certification in Indonesia The original article is prepared in Japanese. To be translated shortly. For the time being, please read it through Google Translate. インドネシアのハラール認証の義務化スケジュール https://cm-plus.co.jp/column/halal/halal3_schedule_for_indonesia/ (Google Translate) Japanese > English https://1-cm--plus-co-jp.translate.goog/column/halal/halal3_schedule_for_indonesia/?_x_tr_enc=1&_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=ja&_x_tr_pto=wapp  
• Halal
  Choosing the Right Halal Certification Body and How to Get Certified The original article is prepared in Japanese. To be translated shortly. For the time being, please read it through Google Translate. ハラール認証機関の選定と進め方 https://cm-plus.co.jp/column/halal/halal2_halal_certification_body/ (Google Translate) Japanese > English https://1-cm--plus-co-jp.translate.goog/column/halal/halal2_halal_certification_body/?_x_tr_enc=1&_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=ja&_x_tr_pto=wapp  
• Halal
  Understanding Halal: Exploring the Global Muslim Population and Future Trends The original article is prepared in Japanese. To be translated shortly. For the time being, please read it through Google Translate. ハラールとは。世界のムスリム人口と今後の動向。 https://cm-plus.co.jp/column/halal/halal1_about_halal/ (Google Translate) Japanese > English https://1-cm--plus-co-jp.translate.goog/column/halal/halal1_about_halal/?_x_tr_enc=1&_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=ja&_x_tr_pto=wapp  

Carbon Neutral

• Carbon Neutral
  Diagnosis of Existing Factories for Carbon Neutral (CN) and Environmental Measures for New Factories, Part 2 Starting with the areas that use the most energy is one strategy. Do you know which piece of equipment in the factory consumes the most energy?Generally, heat source and air conditioning (HVAC) systems are the largest energy consumers. Particularly in pharmaceutical manufacturing processes, these systems account for 50-60%, or even more, of the total energy consumption in the factory. Therefore, it is effective to start energy-saving and carbon-neutral (CN) initiatives by examining the energy-consuming HVAC systems. Pharmaceutical manufacturing typically involves batch production (though there are cases of 24-hour operation). During batch production, there are periods when production is halted, but... energy saving,carbon neutral
• Carbon Neutral
  Diagnosis of Existing Factories for Carbon Neutral (CN) and Environmental Measures for New Factories, Part 1 Let’s start by understanding the energy consumption of your factory. Traditional central monitoring systems, such as BEMS, have primarily been used not only for monitoring equipment but also for understanding the total electricity and gas consumption and reducing demand. However, knowing the overall electricity and fuel consumption of a factory is not enough to devise specific reduction strategies. To reduce the energy consumption of a factory, it is essential to understand what, where, how much, and why energy is being consumed. Recently, energy monitoring equipment and central monitoring systems implemented in factories have become capable of detailed energy consumption tracking.... energy saving,carbon neutral

BIM/DX

• BIM/DX
  Project control utilizing digital transformation (DX) tool Achieve the best project digital execution with CM Plus Many clients are wasting time and money by not being able to utilize the valuable digital information created during projects. In many projects in Japan, BIM utilization from the client's perspective has not been realized. The reason for this is that the construction companies and design offices that create the BIM models do not (cannot) propose to clients a BIM work execution policy that takes into account the client's perspective of operation and maintenance work after the completion of construction work. As a result, after the construction work is completed, clients... DX,BIM

Factory DX, IT/OT

• Factory DX, IT/OT
  Application of DX Technology in Pharmaceutical Manufacturing 2 In the previous issue, we discussed the overall roadmap for DX (Digital Transformation) and organized the control system hierarchy. Approach to DX Implementation DX Implementation Approach CM Plus proposes a DX implementation approach. In order to ensure a solid digitalization process, the first step is to clarify what you want to do and organize your requirements. We will organize the main issues to be solved related to the project's external environment, equipment, and production operations, the data collection methods needed to solve them, and the requirements for digitization and systemization of the data collection methods. Next, a list of candidate... DX,IT/OT
• Factory DX, IT/OT
  Application of DX Technology in Pharmaceutical Manufacturing 1 What is DX (Digital Transformation)? First, let us explain DX (Digital Transformation) from the example of the roadmap. The progress levels of DX are shown in the upper part of the fig.1 as "Digitize," "Digitalize," and "Digital Transformation. While anticipating the digitalization of the industry, it is important to raise issues from the three perspectives shown in the left part of the Fig.1 and utilize digital technology to solve them. The three perspectives are "business category perspective," "customer perspective," and "own company perspective," and it is important to address issues from each perspective in the existing business model area and... DX,IT/OT