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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Regenerative Medicine Consulting

Home/ Services/ Consulting/ Regenerative Medicine Consulting ConsultingRegenerative Medicine Consulting What is a regenerative medicine products?Classification under the Pharmaceutical and Medical Device Act A regenerative medicine product uses cells or genes for the treatment or prevention of diseases or injuries. The scope of regenerative medicine products defined under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act) is as follows: 1.Products in which cells from humans or animals have been cultured or otherwise processed, with the purposes of:a. Reconstruction, repair, or formation of the structure or function of the body of humans or animals.b. Treatment or prevention of diseases in humans or animals. 2.Products intended for the treatment of diseases in humans or animals that involve the introduction of genes into human or animal cells to express them in the body. regenerative medicine products are classified separately from drugs and medical devices under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act). Since regenerative medicine products involve the use of live cells or viruses themselves as products, specialized manufacturing and quality control different from those for drugs and medical devices are required. Difference Between “Products” and “Medical Care” in Regenerative Medicine In regenerative medicine, the applicable regulations differ depending on whether regenerative medicine products are provided by companies or medical care is offered within medical institutions. The former must comply with the Pharmaceutical and Medical Device Act (PMD Act) and adhere to the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) ordinance, requiring appropriate manufacturing facilities and stringent manufacturing and quality control. On the other hand, the latter is subject to theAct on Securing Safety of Regenerative Medicine, under which clinical research or private medical practice must be conducted.   CM Plus’s Support for Regenerative Medicine Products Steps from Development to Manufacturing and Sales...

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Contamination Control Strategy (CCS) Consulting

Home/ Services/ Consulting/ Contamination Control Strategy (CCS) Consulting ConsultingContamination Control Strategy (CCS) Consulting What is the “Contamination Control Strategy (CCS)” Required by the Revised EU GMP and PIC/S GMP Annex 1? In 2022, both EU GMP Annex 1 (August 25, 2022) and PIC/S GMP Annex 1 (September 9, 2022) were revised, resulting in significant changes from the previous Annex 1. Among the key points of the revisions, the “Contamination Control Strategy (CCS)” is required in various sections, making the formulation of CCS a critical topic in the revised Annex 1. What is CCS? (From the PIC/S GMP Annex 1 Glossary) Annex1 Glossary GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES (PE 009-17) Annex1 Glossary Contamination Control Strategy (CCS) – A planned set of controls for microorganisms, endotoxin/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. PIC/S GMP ANNEXES Elements to Consider in the “Contamination Control Strategy (CCS)” The development of CCS requires detailed technical and process knowledge. Potential sources of contamination include microbial contamination, cell debris (such as pyrogens and endotoxins), and particulate matter (such as glass, other visible, and sub-visible particles). The revised Annex 1 requires that the elements to be considered in CCS include at least the following (Annex 1 2.5): 1.Plant and process design (including related documentation) 2.Facilities and equipment 3.Personnel 4.Utilities 5.Raw material management (including in-process controls) 6.Product containers and closures 7.Vendor approval (including suppliers of key components, providers of sterilization -services for parts and single-use systems, and other critical service providers) 8.Outsourced activities (such as contract sterilization services) and the...

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Data Integrity (DI) Consulting

Home/ Services/ Consulting/ Data Integrity (DI) Consulting ConsultingData Integrity (DI) Consulting What is Data Integrity? Data integrity refers to the completeness, consistency, and accuracy of data, and it is required to be ensured throughout the lifecycle of pharmaceuticals. To ensure data integrity, the principles of ALCOA+ are presented within various guidelines. Principles of ALCOA+ 1.Attributable: Data can be attributed to who did what, when, and where. 2.Legible: Data can be read by anyone. 3.Contemporaneous: Data is recorded and created at the time it occurs. 4.Original: Data is original or equivalent to the original. 5.Accurate: Data is recorded and created accurately. 6.Complete: All data exists, not just parts of it. 7.Consistent: Data is consistent and without contradictions. 8.Enduring: Data is protected long-term and exists throughout its lifecycle. 9.Available: Data is accessible and available for use at any time.   Ensuring data integrity is required for all data and records, regardless of whether they are on paper or in electronic form. It is an urgent issue in the pharmaceutical industry, as the reliability of data and records is directly linked to the reliability of the quality of the pharmaceuticals. Data Governance The establishment of data governance requires active involvement from senior management. Senior management is responsible for establishing the organization’s quality culture, maintaining and continuously improving it, and building an effective data governance system. They are also responsible for creating a corporate culture that provides an appropriate working environment, where everything can be reported openly and transparently. A quality culture centered around senior management should be established, along with a data governance system that ensures data integrity throughout the lifecycle. Some specific policies and procedures for operating a data governance system include the following examples. (WHO Annex 4. Guideline on Data Integrity) WHO Annex 4. Guideline on Data Integrity ■ management oversight...

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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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Technical Information Services

Home/ Services/ Technical Information Services ServicesTechnical Information Services The environment surrounding facilities and equipment requiring advanced environmental control, such as those in the life sciences and semiconductor sectors, is evolving to become more international, diverse in scope, and demanding in terms of information processing.Our company, which thrives on challenges in engineering and life sciences manufacturing quality, offers comprehensive information services to support our clients’ international operations. These services address topics related to GMP (Good Manufacturing Practice), QMS (Quality Management Systems), and the latest technological advancements, including digitalization.In addition, we provide product services that include engineering information tools and education and training related to quality. GMP Platform Aggregating knowledge to solve our clients’ challenges GMP Platform is a free information site established based on CM Plus Corporation’s founding principle of addressing various quality-related issues in life sciences facilities while staying close to our customers. We offer a variety of technical articles and translated and explained guidelines. In addition to GMP (Good Manufacturing Practice), we also share information related to clinical and non-clinical studies, as well as quality and safety for medical devices, cosmetics, and even food products. CM Plus aims not only to disseminate the expertise of our experienced in-house consultants and engineers through this site but also to gather and integrate knowledge from top consultants worldwide to help solve any challenges our clients may face. GMP Platform Internet Virtual Exhibition for Life Science Life Science Company Information Platform Life Science Company Information Platform is a specialized portal site where top suppliers, who constitute the robust supply chain in the life sciences industry, showcase and share extensive information on their latest technologies, products, and services. Those seeking the latest information on technologies, products, and services related to life sciences can access a wealth of information from various perspectives provided by the...

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Projects

Home/ Portfolio/ Projects PortfolioProjects Japan 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. Cosmetics “Show” cosmetics factory TOYO BEAUTY 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.) Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting Jitsubo CO., LTD. Data Centers System module type data centerRealizing short construction period and low cost Internet Initiative Japan Inc.(IIJ) Other Countries Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility that considers people, the community, safety, and the environment. Terumo Vietnam Co., Ltd. Food／Flavor・Fragrance Smooth project execution between Asia headquarter and Japan head office Takasago International Singapore Pte. Ltd. Pharmaceuticals and Medical Devices Production line reinforcement for pharmaceutical manufacturing factory Medreich Limited The above are examples of our achievements.Please feel free to inquire about our achievements in your field of interest. Related Contents →Performance by Numbers

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Consultants

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