2025 CQV engineering consultancy
Qualification of a tablet inspection line
- Challenge
- Deliver qualification of a tablet inspection line, including the related documentation, according to plan.
- Outcome
- Completed on budget and on schedule.
Commissioning · Qualification · Validation
Japan-based CQV consulting and engineering support
For pharmaceutical manufacturing facilities in Japan, in Japanese and English.
CQV JAPAN supports pharmaceutical companies, engineering firms and equipment suppliers with the commissioning and qualification of manufacturing equipment and utilities. Our representative director brings 24 years of pharmaceutical engineering and CQV experience, including in-house roles at multinational pharmaceutical companies.
Representative Director
Suguru Matsuzawa
24 years in pharmaceutical engineering & CQV
Based in Japan
Support for pharmaceutical manufacturing facilities in Japan
Commissioning, Qualification & Validation
From URS and risk assessment through IQ, OQ, PQ and process validation
Multinational experience
In-house engineering roles at multinational pharmaceutical companies
Japanese & English
Technical documents and meetings in both languages
From user requirements to performance qualification and process validation, we support the full lifecycle.
- 01
URS
User requirements
- 02
SRA
Risk assessment
- 03
DQ
Design qualification
- 04
FAT/SAT
Factory / site acceptance
- 05
IQ
Installation qualification
- 06
OQ
Operational qualification
- 07
PQ
Performance qualification
- 08
PV
Process validation
What is CQV
Commissioning, Qualification & Validation
CQV is the set of activities that demonstrates pharmaceutical manufacturing equipment works as intended and protects product quality. Because it spans design, installation, testing, documentation and quality risk management, it is best handled by people who specialize in it.
C
Commissioning
Engineering activities that confirm equipment has been installed and adjusted as designed and is ready to operate.
Q
Qualification
Documented evidence, through stages such as DQ, IQ, OQ and PQ, that equipment and utilities affecting product quality are fit for their intended use.
V
Validation
Establishing that manufacturing and cleaning processes consistently deliver results of the required quality. Equipment qualification is a prerequisite.
Planning the three as one continuous flow, for example by leveraging commissioning test records in qualification, reduces duplication while making sure that quality-critical aspects are verified.
Why CQV JAPAN
A local CQV partner for your projects in Japan
For multinational pharmaceutical companies, engineering firms and CQV teams that need Japan-based support for commissioning and qualification.
01
A partner based in Japan
We support pharmaceutical manufacturing facilities in Japan and work with your local site team, vendors and contractors.
02
Experience inside multinational companies
Our representative director spent over a decade in engineering roles at multinational pharmaceutical and biopharmaceutical companies, including technology transfer of overseas products to Japan.
03
Technical communication in two languages
Technical documents and meetings in English, and clear communication with Japanese vendors, contractors and site staff.
04
Three perspectives on C&Q
Hands-on C&Q experience from the contractor, the pharmaceutical manufacturer and the CQV consultancy side.
Services for Companies
CQV services
We support projects for the engineering, facilities and quality functions of pharmaceutical companies, as well as engineering firms and equipment suppliers, from planning through test execution.
Consulting
CQV / C&Q Consulting
C&Q planning, URS, risk assessment, protocol and report review, and support for test execution. We also take on specific parts of a project.
- C&Q planning and VMP support
- URS preparation and review
- System risk assessment (SRA) and FMEA
- Review of DQ, FAT, SAT, IQ, OQ and PQ documents
- Support for test execution and on-site witnessing
- C&Q for technology transfer
Spot Consulting / Advisory
Spot consulting & monthly technical advisory
Start with a single document review or technical question. For ongoing support, monthly technical advisory is also available.
Learn more →Representative
Builder, user, qualifier.
24 years of pharmaceutical engineering and CQV.
After graduating in mechanical engineering from Kyushu University in 2002, Suguru began his career in pharmaceutical facility engineering. His experience spans the equipment lifecycle, from introducing and constructing manufacturing equipment through URS, risk assessment, DQ, FAT, IQ, OQ, PQ, technology transfer and GMP compliance.
- Three perspectives
- C&Q experience from the side that builds facilities (a general contractor), the side that operates them (pharmaceutical manufacturers) and the side that supports qualification (a CQV engineering consultancy).
- Full lifecycle
- From URS and risk assessment through DQ, FAT, SAT, IQ, OQ, PQ, process validation and technology transfer.
- Working in English
- At multinational pharmaceutical companies, led meetings with overseas colleagues and handled technical communication with contract manufacturing organizations (CMOs).
Selected experience of our representative
2022–2025 Multinational biopharmaceutical company
Technology transfer of syringe and vial products
- Challenge
- Transfer overseas products to the Japanese market so that they could be manufactured at a contract manufacturing organization (CMO).
- Outcome
- Managed the transfer through PQ for the syringe product and through the PQ stage for two vial products.
2014–2022 Multinational pharmaceutical company
Upgrade and qualification of HVAC, compressed air and purified water systems
- Challenge
- Address issues identified in a gap analysis against PIC/S requirements through upgrades to manufacturing and packaging areas.
- Outcome
- Delivered the upgrades without impacting the production schedule.
The above describes our representative’s personal experience in previous roles and does not represent projects delivered by CQV JAPAN. Company and project names are withheld for confidentiality.
Equipment & Disciplines
Equipment and technical disciplines
Equipment and disciplines our representative has worked on in previous roles. For equipment not listed here, please contact us and we will let you know whether we can help.
Equipment
Solid dosage
Granulation linesFluid bed equipmentVacuum dryersContainment tablet linesHard capsule linesTablet inspection lines
Packaging & parenteral-related
Blister packaging machinesSyringe secondary packaging linesVial lines
Utilities & facilities
HVACCompressed airPurified waterWarehouse HVAC (humidity control)Access control
Disciplines
CQV / C&Q
URSSRA / FMEAVMPDQFATSATIQOQPQPV
GMP & quality systems
DeviationsCAPAChange controlSOPsGMP gap analysis
Projects
Technology transferFacility construction & upgradesCMO collaborationEffort estimation & quotationsGlobal meetings
Pricing
Pricing
Quoted individually
All engagements are quoted individually, based on the scope of your request, the volume of documents, the duration, whether support is remote or on site, and the deliverables. Travel and accommodation costs for on-site support are discussed when quoting.
Pricing detailsProcess
How we work with you
- 01
Inquiry
Tell us about the equipment, process, timeline and challenges using the contact form.
- 02
Initial call
We discuss your current situation and objectives online and define the scope of support.
- 03
Proposal & quotation
We propose the scope, resourcing, duration, deliverables and fees.
- 04
Agreement & kickoff
Support begins according to the agreed scope and schedule.
FAQ
Frequently asked questions
What kinds of companies and teams do you work with?
We work with the engineering, facilities and quality functions of pharmaceutical companies, as well as engineering firms, equipment suppliers and CQV service providers. We can also support specific parts of a project.
Can you join a project that is already under way?
Yes. We can start by reviewing existing URS, protocols and reports, or by supporting the test execution phase of an ongoing project.
Do you guarantee compliance in regulatory inspections?
No. We provide technical advice and support based on the relevant guidelines and hands-on experience. Final decisions and responsibility remain with your quality organization.
Can you work with English documents and overseas teams?
Our representative director has prepared documents in English and led meetings with overseas colleagues at multinational pharmaceutical companies. We will confirm the scope of support based on your needs.
Contact
Planning a CQV project in Japan?
Let's talk.
From early planning to supporting part of an ongoing project. Tell us about your situation, in English or Japanese.