CM Plus group to speak at ISPE Indonesia Annual Conference 2025

ISPE Indonesia Annual Conference is the annual conference held by ISPE Indonesia Affiliate. This year, it is scheduled on 21, 22 May, 2025, in Jakarta, Indonesia. CM Plus, with PT.CMPLUS CONSULTING INDONESIA, will sponsor as platinum sponsor and make presentation. More information will follow. Here are the details. Presentation Outline Track - Title Project Management of Renovation Projects Table of contents 1. Purpose of Renovation Work 2. Project Management of Renovation Work 3. How to design in order to make Renovation Work easily 4. How to deliver C&Q for Renovation Work 5. Short Introduction of CM Plus Group Presenters Yasuyuki Suga (Mr.) General Manager of CM Plus Corporation (Japan) Director of ISPE Japan Affiliate Leader of Engineering COP in ISPE Japan Affiliate Date and Time Wednesday 21th May, 2025 xx:xx – xx:xx Venue - Conference Outline Title ISPE Indonesia Annual Conference 2025 Date 21-22 May, 2025 Venue Aston Kartika Hotel & Conference Center, Jakarta, Indonesia

https://cm-plus.co.jp/en/news/event/2025_0417/

Pharmaceuticals and Medical Devices

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices SectorsPharmaceuticals and Medical Devices CM Plus responds to clients’ needs with top-level expertise and technical capabilities in the construction of production facilities in the fields of pharmaceuticals, medical devices, and more. From sterile pharmaceuticals to active pharmaceutical ingredients, regenerative medicine, and medical devices, we have been meeting numerous needs since our founding, from the business planning stage to basic design, construction, and IQ/OQ phases.We flexibly respond to client situations, not only for new construction, but also for expansion, relocation, partial renovations, and technology transfer. Sector Details Our services range from pharmaceuticals (sterile pharmaceuticals, oral drugs, active pharmaceutical ingredients, vaccines, biopharmaceuticals, investigational drugs, and diagnostics) to medical devices, regenerative medicine, and cell therapy.We also provide a wide range of services from R&D facilities to clinical trials, pilot plants, and commercial production. Sterile Pharmaceuticals Oral Drugs Medium-Molecule API Large-Molecule (Biopharmaceutical) API Regenerative Medicine (Consultation Service) Features The pharmaceutical and medical device sectors deal with products that directly impact human health, thus requiring stricter quality control than other products. The characteristics of manufacturing facilities include: Compliance with GMP is required (PIC/S, cGMP, EU-GMP, and GMPs of various countries). Advanced environmental control (cleanliness management, temperature and humidity management, room pressure management, pharmaceutical water management, etc.) is necessary. Advanced hazard management (chemical hazards, biohazards), management of hazardous materials, and management of poisons/narcotics may be required. Since the production equipment and the building/architectural facilities need to function as a cohesive unit, complex integrations between them arise. Proper commissioning and qualification (C&Q) based on accurate risk analysis are required. Keys to Success How to Ensure the Success of Construction Projects in the Pharmaceutical and Medical Device Sectors: From the early planning stages, proceed while consciously including GMP compliance and validation at each step by confirming specifications accurately....

https://cm-plus.co.jp/en/service/engineering/field/pharma_medical-device/

Sterile Pharmaceutical Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Sterile Pharmaceutical Manufacturing Facility Pharmaceuticals and Medical DevicesSterile Pharmaceutical Manufacturing Facility About Sterile Pharmaceuticals Sterile pharmaceuticals include injectable drugs administered by injection, dialysis agents administered through dialysis, and eye drops administered to the eye. Direct containers in contact with the drug have functions to maintain the quality of the drug and to ensure user convenience. These containers include ampoules, vials, cartridges, infusion bags, pre-filled syringes (PFS), blow-fill-seal (BFS), form-fill-seal (FFS), and plastic containers. Sterile pharmaceuticals are manufactured using either terminal sterilization methods or aseptic processing methods to ensure sterility. When handling various containers such as vials and syringes, the supply form of direct containers called NEST, where pre-washed and sterilized direct containers are set in dedicated cases, is sometimes used. In such cases, devices like filling machines are also dedicated to NEST, but they feature easy container switching. Filled products are packed in single or multiple layers of films or paper, labeled with legally mandated information (such as lot numbers, expiration dates, and GS1 barcodes), and maintain the quality of the product during transportation and prevent errors and ensure convenience during use. Example of a Sterile Pharmaceutical Manufacturing Process The following diagram illustrates the process flow of a vial product using the aseptic method as an example of a sterile pharmaceutical. Example of Process Flow Diagram:Vial Product Using Aseptic Method   Weighing of raw materials, preparation and processes from washing of containers filling/stoppering/sealing, these processes are conducted in a clean room controlled for appropriate particle count, temperature, and humidity to prevent microbial and foreign matter contamination. Particularly, the filling and stoppering processes are performed in grade A cleanliness environments, classified as critical areas. Vials are depyrogenized through a dry heat sterilization tunnel, while rubber stoppers are washed and sterilized using...

https://cm-plus.co.jp/en/service/engineering/field/pharma_medical-device/sterile_medicine/

Oral Drugs Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Oral Drugs Facility Pharmaceuticals and Medical DevicesOral Drugs Facility About Oral Pharmaceuticals There are numerous oral preparations taken by mouth, with representative types including tablets, capsules, granules, and powders. Tablets, in particular, can come in forms such as uncoated tablets, film-coated tablets, and sugar-coated tablets. The primary packaging, which directly contacts with the drug, functions to maintain the quality of the drug and ensure user convenience. This primary packaging includes PTP (Press Through Package) blister packaging, strip packaging, sachet packaging, stick packaging, and bottle packaging. Primary packaging products are further wrapped with single or multiple layers of film or paper, carrying regulatory-required labels (such as batch number, expiration date, GS1 barcodes, etc.) to maintain the quality of the product during transportation and prevent errors and ensure convenience during usage. Example of Manufacturing Process for Oral Pharmaceuticals The following diagram illustrates a process flow chart for a film-coated tablet blister package product as an example of an oral formulation. Process Flow Chart Example: Film-Coated Tablet Blister Packaging   The preparation process and primary packaging process are conducted in a clean room where temperature, humidity, and particulate matter are controlled to prevent microbial and foreign matter contamination into the products. During the preparation process, raw materials and intermediate products for each batch are handled using containers between different process stages. Tablets are engraved or printed with the product name or other information. After they are visually inspected, samples are taken for quality testing. Lots that pass the quality tests proceed to primary PTP packaging and secondary packaging as pillow packaging, cartoning, printing & inspection and cardboard packing. Unlike the preparation process, where between each stage requires manual handling, the packaging process is normally fully automated. Lots that pass the final quality tests...

https://cm-plus.co.jp/en/service/engineering/field/pharma_medical-device/oral_agent/

Medium-Molecule API Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Medium-Molecule API Manufacturing Facility Pharmaceuticals and Medical DevicesMedium-Molecule API Manufacturing Facility Classification Name Low Molecular Weight Medium Molecular Weight High Molecular Weight Molecular Weight ～500 500～2,000 2,000～ Examples Synthetic Organic Pharmaceuticals eptide Pharmaceuticals Nucleic Acid Pharmaceuticals Antibody Drugs Vaccines Main Manufacturing Methods Organic Synthesis Peptide Synthesis Nucleic Acid Synthesis Microbial Culture Animal Cell Culture Medium-Molecule APIs are considered to have a molecular weight of approximately 500 to 2,000. Since the molecular weight of organic synthesis APIs is below 500, and that of APIs produced by microbial or animal cell culture is around 150,000, the former are called Low-Molecule APIs and the latter High-Molecule APIs. The intermediate ones are referred to as middle molecular weight APIs. Medium-Molecule APIs are broadly divided into peptide pharmaceutical APIs and nucleic acid pharmaceutical APIs. Types and Characteristics of Medium-Molecule APIs Peptide Pharmaceutical APIs Peptide pharmaceutical APIs are obtained by synthesizing peptides through solid-phase or liquid-phase reactions that bond 20 types of amino acids. The synthesized peptides need to have the structure of the active sites of proteins that are usually generated in the body. Generally, the peptides are often cyclic to make them less susceptible to degradation and modification. Nucleic Acid Pharmaceutical APIs Nucleic acid pharmaceuticals make use of nucleic acids such as DNA and RNA, which carry genetic information, in medicinal applications. Since nucleic acid pharmaceuticals can be manufactured with synthetic techniques similar to those used for small molecule pharmaceuticals, they can be produced at a lower cost compared to high molecular weight APIs. Moreover, they can target molecules like mRNA and miRNA, which cannot be targeted by either small or high molecular weight pharmaceuticals. Manufacturing Facilities for Middle Molecular Weight APIs ~Key Points in Construction~ Laboratory Scale Facility Adaptation During the drug discovery...

https://cm-plus.co.jp/en/service/engineering/field/pharma_medical-device/medium_molecule_drugs/

Large-Molecule ( Biopharmaceutical ) API Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Large-Molecule API Manufacturing Facility Pharmaceuticals and Medical DevicesLarge-Molecule (Biopharmaceutical) API Manufacturing Facility Classification Name Low Molecular Weight Medium Molecular Weight High Molecular Weight Molecular Weight ～500 500～2,000 2,000～ Examples Synthetic Organic Pharmaceuticals eptide Pharmaceuticals Nucleic Acid Pharmaceuticals Antibody Drugs Vaccines Main Manufacturing Methods Organic Synthesis Peptide Synthesis Nucleic Acid Synthesis Microbial Culture Animal Cell Culture Large-Molecule APIs include mainly microbial culture APIs and animal cell culture APIs. These APIs are produced by combining techniques such as genetic recombination, cell banking, cell culture, extraction, and purification to generate the active protein components. Examples include antibodies, enzymes, hormones, and interferons. It is expected that they will address unmet medical needs, which were difficult to address with small molecule pharmaceuticals. Since these APIs involve handling biological organisms and proteins, ensuring the sterility of manufacturing facilities and managing the biological aspects of environmental conditions are necessary. Types and Characteristics of Large-Molecule APIs Materials Used in Large-Molecule (Biological) Pharmaceuticals and Major Pharmaceuticals   Material Major Pharmaceuticals Host Cells Animal Cells CHO, SP2/0, NS0, Human Cells (HT1080, HEK), etc. Blood Coagulation Factors Erythropoietin Antibodies Lysosomal Enzymes Fc Fusion Proteins Microorganisms E. coli Insulin Growth Hormone Interferon Cytokines Enzymes Insulin Glucagon Human Serum Albumin HPV Vaccine Insect Cells HPV Vaccine Plant Cells Rice, Tobacco, Carrot Recombinant Lactoferrin Influenza Vaccine Recombinant Anti-Ebola Virus Antibody Gaucher Disease Treatment Source Cells Animal Heparin Hyaluronic Acid Plant Medicinal Herb Morphine Aspirin Plasma Immunoglobulin Albumin Blood Coagulation Factors Fibrinogen Antithrombin Haptoglobin Orphan Drugs Microbial Culture APIs Microbial cultures can be divided into those that use naturally occurring microorganisms and those that use genetically modified microorganisms. The latter involve engineering microorganisms such as E. coli and yeast to incorporate genes that code for the desired substances (APIs) and then producing (expressing) these substances...

https://cm-plus.co.jp/en/service/engineering/field/pharma_medical-device/macromolecular_drugs/

Consulting

Home/ Services/ Consulting ServicesConsulting Gathering "knowledge" together and offering solutions For the purpose of ensuring quality at production sites of drugs/medical devices, we gather "knowledge" of first-rate consultants internationally and offer consulting services from the GMDP (GMP & GDP) / QMS / pharmaceutical regulatory affairs point of view. *GMP: Good Manufacturing Practice *GDP: Good Distribution Practice *QMS: Quality Management System Advantage of CM Plus's GMDP/QMS/Pharmaceutical Regulatory Affairs consulting services Advantage01 Gathering "knowledge", first-rate consultants from various areas CM Plus works not only with our own consultants but also with top-rate consultants around the globe. Consultants specialized in various areas such as manufacturing, QC, QA, pharmaceutical regulatory affairs, and interpretation for audits for drugs, medical devices, and regenerative medicine products would willingly help you The ability to put the skills and knowledge together for finding solutions is an advantage of CM Plus. Profiles of our consultants Advantage02 Attractiveness you can find in one of the biggest GMP information websites in Japan CM Plus is sharing GMP-related regulatory information on its website that is called "GMP Platform". The website is one of the biggest in Japan with more than 12,000 members who work mainly for industries of drugs and medical devices.CM Plus keeps attracting GMDP/QMS-related "knowedge" all the time. GMP Platform Advantage03 From supplier audits, quality system improvements, audits supports to developments of human resources.CM Plus has its own practical system to support our clients. Along a lifecyle of the product and production facility, CM Plus provides our clients with consistent support from supplier audits, quality system improvements, audit support and development of human resources working at the facility.We firmly support your efforts to establish quality in a practical way. Consulting by CM Plus GMDP consulting services for drugs For GMDP improvement, audit support, education and training on GMDP, support for supplier...

https://cm-plus.co.jp/en/service/consulting/

Pharmaceutical GMP & GDP Consulting

Home/ Services/ Consulting/ Pharmaceutical GMP & GDP Consulting ConsultingPharmaceutical GMP & GDP Consulting Do you have any of these wishes regarding building in quality? We want to prepare for regulatory inspections. We want a partner who can concretely advance the construction/improvement of quality systems. We want to eliminate concerns about problems and risks lurking in the manufacturing facility. We want personnel responsible for auditing external contractors’ manufacturing plants and raw material suppliers. We want to efficiently establish a quality system in new business areas. With CM Plus’s GMDP Consulting, we offer the following support for Regulatory inspections such as those by the FDA and PMDA: Mock inspections Inspection response training Back office support during inspections Assistance in responding to inspection observations findings Support for improving identified issues Interpretation for overseas audits Comprehensive proposals for the establishment construction and improvement of PQS, storage management of raw materials, facility workflow improvements, and on-site operational improvements. Our strength includes the smooth proposal of facility improvements, supported by our in-house engineering consultants. By conducting GAP analysis, we first clarify the discrepancies (gaps) between the “current state” and the “desired future state” of the manufacturing site. We identify hidden risks and issues from both equipment/facility and quality system perspectives and provide improvement proposals. Experienced consultants conduct quality audits on your behalf. We train GMP Auditors (inspectors). Based on extensive experience, we support the establishment of quality systems and preparation of procedures tailored to the scale of personnel and other conditions. Additionally, CM Plus houses regulatory and validation experts, allowing us to offer one-stop consultations for these matters as well. First-rate consultants in/outside Japan will support you fo quality improvement by providing GMDP improvement consulting services.   Support for improving A：Support for establishing/improving your quality system As to manufacturing control/quality control, which supports quality of drugs...

https://cm-plus.co.jp/en/service/consulting/gmdp_consulting/

QMS for Medical Devices

Home/ Services/ Consulting/ QMS for Medical Devices ConsultingQMS for Medical Devices Support for New Entry into the Medical Device Industry The global market size for medical devices is estimated to be approximately 30 trillion yen, with around 2.8 trillion yen in Japan alone. This market is large and attractive for new entrants; however, medical devices are subject to stringent regulations under the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (abbreviated as the Pharmaceuticals and Medical Devices Act or PMD Act). Even if a material or technology can be applied to medicine, there are significant hurdles to overcome in order to introduce it as a medical device to the market. CM Plus supports new entries by building a quality management system (QMS) based on the QMS Ordinance (ISO 13485) and conducting product design and development in accordance with the QMS from the early planning stages of medical devices, ensuring a smooth and irreversible entry into the market. Roadmap from Development to Market Launch of Medical Devices   “Medical Device Development Support Handbook” Revised in October 2023 From the Cabinet Secretariat (Healthcare and Medical Strategy Office), Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, and Ministry of Economy, Trade and Industry ※indicates the scope of CM Plus’s medical device consulting services. Examples of Progression Steps within Japan STEP01 Acquisition of medical devices Marketing License and Registration of Manufacturing Business The manufacturing and marketing of medical devices in Japan must comply with the Pharmaceuticals and Medical Devices Act (PMD Act). To conduct manufacturing and marketing, it is necessary to obtain a medical devices marketing license, and to conduct manufacturing, it is required to register as a manufacturing business. STEP02 Establishment of QMS (Quality Management System) In order to carry out...

https://cm-plus.co.jp/en/service/consulting/qms_consulting/

Regulatory Affairs Consulting

Home/ Services/ Consulting/ Regulatory Affairs Consulting ConsultingRegulatory Affairs Consulting Pharmaceutical life cycle and task at each step Each step in the pharmaceutical life cycle involves the following tasks:   * The red underline indicates the scope of CM Plus's regulatory consulting service. Pharmaceutical Regulatory Affairs Consulting from CM Plus Our experts offer pharmaceutical regulatory affairs consulting services with abundant practical experience of the industry to meet our customers' needs. Regulatory Application Strategy Building Internal Systems such as GQP / GVP Various Consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) Support for Manufacturing/Marketing Business License for Pharmaceutical Products etc./ Manufacturing Business License/ Application for Accreditation of Foreign Manufacturers (including Support for Inquiry Response) Business Support for Creating Approval Application Forms and Application Materials Business Support for Partial Change, minor change (including support for inquiry response) Customer’s Benefits from CM Plus Pharmaceutical Regulatory Affairs Consulting 1. Regulatory Affairs Consulting Services at all stages, from Development to Post-Marketing CM Plus provides consulting services for regulatory affairs development, CMC regulatory affairs, and pharmaceutical regulatory affairs at all stages, from the development stage, approval application, manufacturing, to post-marketing. We can handle new drugs, generic drugs, long-listed drugs (after the re-examination period), and various types of drugs. 2.Regulatory Affairs Consulting Services in Collaboration with GMP Consulting Services. CM Plus provides two services. The first is "GMP consulting services, from the perspective of GMP manufacturing and QA quality assurance department" (on-site support). The second is "pharmaceutical regulatory affairs consulting services, from the perspective of regulatory interpretation and document procedures" (we provide consulting service of regulatory response to regulatory authorities, from application to inquiry response). Combining these two services enables us to provide collaborative GMP, QA, and regulatory consulting services that are more suitable for the site.   Designated Marketing Authorization Holder and In-Country Clinical Caretaker CM...

https://cm-plus.co.jp/en/service/consulting/regulatory_affairs/