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.

Support for improving

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 improvement of 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.

C：Support for establishing/improving your raw material system

CM Plus makes proposals on how to improve the selection and management of suppliers, the management of warehouse storing raw materials and products, management of carrying 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 control of samples, reference standards and reagents, qualification, maintenance, and calibration of laboratory instruments, and analytical method validation and ensuring data integrity.

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.

• For the validation of manufacturing facilities and architectural equipment, please see here.

  Validation Consulting

Audit support

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 advices and proposals for improvement based on the client’s status of preparation. In addition, we provide support at backyard during audits and for handling observations 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
• Training for audit responders
• 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

 

GMDP ( GMP & GDP ) Education/Training Support

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 “e-Learning” and “open seminars” for individuals, and “on-site seminars” for organizations.

Support for supplier control

Experienced consultants provide support for quality audits (supplier audits)
We can also support for audits of API/drug formulation manufacturers and raw material/packaging and labeling material suppliers.

A：Support for the Implementation and Delegation of Domestic and Overseas Quality Audits

CM Plus conducts quality audits together with you or on your behalf for contract manufacturers and suppliers of raw materials and materials. Our experts, with extensive consulting experience both domestically and internationally, handle these tasks. We support audits not only for domestic manufacturing sites but also for overseas manufacturing sites.

B：Auditor Training Support

CM Plus offers educational training for beginners, newcomers and training supervisors to support the development and internal certification of auditors. For companies facing a shortage of audit personnel, our regularly held “GMP Auditor Training Program” has been well received. This program uses original, systematically designed materials created by experienced instructors and includes practical exercises (role-playing) simulating real-life scenarios as closely as possible.

Other Services

A：GMP for Investigational Medicinal Products (IMPs)

CM Plus provides support for building a cGMP system for investigational medicinal products and for setting up Standard Operating Procedures (SOPs). This includes situations where biotech ventures and other companies completely outsource the manufacturing of their investigational compounds as they move into developmental stages.

B：GQP Operations Support

Regarding GQP (Good Quality Practice), which is unique to Japanese regulations, our experienced consultants provide support for the establishment of GQP systems and the improvement of SOPs.