GMDP consulting services for medicines
First-rate consultants in/outside Japan will support you for better quality by providing advice for better GMDP control.
A: Support for establishing/improving your quality system
As to manufacturing control/quality control, which supports quality of drugs and related to all the activities from B to E shown below, CM Plus provides support for establishment and continuous improvement according to guidelines such as "PIC/S GMP Guide Part I/II". We makes proposals how it should be about SOP's document system established based on your quality policies, and provide support for establishing written procedures and records which support quality at the manufacturing site.
B: Proposals for better facility and equipment systems
CM Plus reviews the layout, cleanliness classification, the flow of personnel and materials according to GMP then makes proposals of measures for improvement. We also coach our clients in qualification such as DQ, IQ, and OQ, and in how to fill in records. The records will also be reviewed. In this way, we provide our clients with support for qualification which can be implemented smoothly and you won't need to carry out the process again. Also, we provide our clients with consulting services on CSV according to the latest information such as "PIC/S GMP Guide Annex 11".
C: Support for establishing/improving your raw material system
CM Plus makes proposals of appropriate control methods for selecting suppliers, storing raw materials and products, putting materials in/out of warehouses, and distribution.
D: Support for establishing/improving lab control system
CM Plus provides support for establishing systems to control the whole lab including measures to ensuring data integrity from control of samples, reference standards and reagents to qualification, maintenance, and calibration of laboratory instruments, and method validation.
E: Support for validation activities
After the publication of "FDA Guidance" in 2011 and the revision of "PIC/S GMP Guide Annex 15" in 2015, the concept of process validation drastically changed and was positioned as continuous activities to be done throughout product lifecycle. CM Plus reviews our clients' CMC data and propose effective approaches so that you can ensure appropriate traceability of your evidence data accumulated during development of your products. Also, we will support our clients for developing continuous improvement based on product quality reviews.
CM Plus performs mock audits with our auditors who have experience of audits in Japan/U.S./Europe or used to be the auditor at the authority. Based on the mock audits, we provide our clients with appropriate instructions and proposals for improvement based on the client's status of preparation. In addition, we provide support at backyard during audits and for handling findings provided after audits.
- Mock audits performed by our auditors who have experience of audits in Japan/U.S./Europe or used to be the auditor at the authority (a simulation performed in the same way as the actual audits)
- Analysis of the current capability of our clients in terms of GMP audits and proposals for improvements
- Providing support for preparing various documents and meeting with the authority
- *Examples of our support for FDA audits: providing support for preparing packages for preliminary meetings (Type C Meeting) and attending meetings
- Giving advice at backyard during audits about preparation of materials and responses
- Providing support for preparing written agreements for making improvement in response to findings provided during an audit and for preparing written responses
Support for GMDP education and training
For drug production activities, it is important to give your employees effective education on GMDP continuously and make them understand GMDP correctly. CM Plus offers you "eLearning" and "open seminars" for individuals, and "on-site seminars" for organizations.
Support for supplier control/purchase control
Experienced consultants provide support for quality audits (supplier audits)
We can also support for audits of API/preparation manufacturers and raw material/packaging and labeling material suppliers.
- Support for auditor training
- CM Plus provides support for training and certifying auditors internally by offering education and training programs for beginners, persons who have been recently appointed, and persons in charge of training.
- Support for implementation of quality audits
- In many cases, companies don't have a sufficient number of staffs for audits.
- CM Plus can send you experienced auditors. We can also arrange interpreters for overseas audits.
A: Consulting services for regenerative medicine-related areas
Utilizing a great stock of know-how developed in sterile drugs and biomedicines, CM Plus offers our clients comprehensive supporting services for regenerative medicine.
- Support for establishing quality systems for regenerative medical products/processed cells
- CM Plus supports our clients for establishing customized quality management systems according to our clients' requirements in terms of operation such as using the system in a small organization.
- Support for diagnosing/establishing facilities and equipment
- CM Plus supports our clients for a series of works for establishing facilities including compliance diagnosis and designing, facility designing and construction control, and validation.
B: Support for overseas plants
- Maintenance of facilities and equipment
- CM Plus provides support for designing, construction control, installation, and validation for remodeling and additional construction works, too.
- Services of education on GMP
- We provide education on GMP in a systematic way in both English and local languages for expatriates and local employees.
C: Support for M&A
At production facilities, due diligence is an important factor when the value is calculated for acquisition.
CM Plus provides support for M&A with appropriate due diligence from the perspective related to design, construction, maintenance, and operation system of the facilities and GMDP.
We provide support for your business in China, Vietnam, Indonesia, and other countries with interpreters who can speak in Japanese, English, and another language.
- Interpreters for audits (audits conducted in Japan by non-Japanese authorities, and audits conducted in China, Vietnam, or Indonesia by PMDA)
- Interpreters for mock audits (in Japan, China, Vietnam, or Indonesia)
- Interpreters for supplier audits
- (audits conducted in Japan by non-Japanese companies, and audits conducted in China, Vietnam, or Indonesia by Japanese companies)