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CQV JAPAN
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CQV Consulting & Technical Advisory

Need a second opinion on a CQV decision?

A Japan-based CQV specialist, available when you need one.

From URS, DQ, FAT, SAT, IQ, OQ and PQ to risk assessment and validation strategy. We support practical technical decisions based on 24 years of pharmaceutical engineering experience.

  • Direct support from our representative director, with 24 years of CQV experience
  • From a single spot consultation to monthly technical advisory
  • Primarily remote, with English documents and meetings supported
Request a CQV Consultation →See our services

Fees are quoted individually based on your request.

Suguru Matsuzawa, Representative Director of CQV JAPAN

Representative Director

Suguru Matsuzawa

24 years of CQV experience

Common Challenges

Do any of these sound familiar?

  • 01

    Unclear test scope

    What belongs in qualification, and what can be verified during commissioning? Without a clear rationale, testing and documentation keep growing.

  • 02

    URS and tests don't connect

    Traceability between requirements, design and tests is hard to follow, and every review uncovers gaps or duplication.

  • 03

    Unsure how to use vendor documents

    You have not yet agreed with QA how far FAT and SAT records can be leveraged for IQ and OQ.

  • 04

    No one to consult internally

    Few people can review CQV in depth, so one person ends up carrying the decisions alone.

  • 05

    Concerns ahead of inspections or audits

    You want to confirm that existing protocols and reports will hold up in terms of acceptance criteria and records.

  • 06

    Working across languages

    Aligning technical points between global teams and Japanese vendors, contractors or site staff takes time, especially across English and Japanese.

Our Value

What CQV JAPAN brings

We don't just hand over answers. We help you build a rationale you can explain within your organization.

We put the rationale into words

We clarify why a test is or is not needed from a quality risk and requirements perspective, so that you can explain it to your organization and QA.

We focus on what affects quality

Based on risk assessment, we revisit test depth and document volume and direct limited time and people to quality-critical aspects.

We see it from three sides

With experience as the builder, the user and the qualification consultant, we frame issues with the needs of vendors, contractors and QA in mind.

As much as you need, when you need it

Rather than a full-time placement, we back up your internal team through spot consulting or monthly technical advisory.

How we support you

  • Online technical consultation

    We work through difficult decisions, such as test scope or CQV strategy, in online sessions.

  • Document review

    We review URS, risk assessments, protocols and reports for traceability to requirements and for sound acceptance criteria.

  • Ongoing technical advice

    We provide continuous advice through regular meetings and email as your project progresses.

Services

Two ways to work with us

Choose spot consulting or monthly technical advisory to suit your situation. Both are quoted individually.

Spot Consulting

CQV Spot Consulting

Resolve one open question in a short time.

When it fits

  • You face a difficult decision at a specific project stage
  • You want an independent review of a specific document, such as a URS, risk assessment or protocol
  • You would like to hear a specialist's view first

What's included

  • Technical consultation on CQV strategy and test scope (online)
  • Review of URS, SRA/FMEA and DQ/IQ/OQ/PQ documents
  • Defining how to leverage FAT/SAT records
  • Joining meetings to work through open issues (online)

Example deliverables

  • Review comment log
  • Memo summarizing issues and rationale
  • Meeting notes

Fees

Quoted individually

We quote based on your request, the volume of documents and the duration.

Ask about CQV Spot Consulting →

Technical Advisory

Monthly CQV Technical Advisory

A CQV specialist your team can turn to.

When it fits

  • Your equipment installation or expansion project runs for several months
  • Your team needs someone to consult promptly when unsure
  • You want to steadily raise the quality of CQV thinking and documentation in your organization

What's included

  • Regular technical meetings (online)
  • Ad hoc consultation by email
  • Ongoing review of project documents
  • Short internal study sessions

Example deliverables

  • Monthly consultation log
  • Review comment log
  • Study session materials

Fees

Quoted individually

We quote based on the frequency, scope and duration of support.

Ask about Monthly CQV Technical Advisory →

Scope & References

Scope, and the regulations and guidelines we reference

Planning & requirements

  • CQV plan
  • VMP
  • URS
  • Requirements-to-test traceability
  • Validation strategy

Risk assessment

  • System risk assessment (SRA)
  • FMEA
  • Risk-based C&Q

Commissioning

  • Design review
  • FAT
  • SAT
  • Start-up

Qualification

  • DQ
  • IQ
  • OQ
  • PQ
  • Protocols & reports

Computerized systems

  • CSV
  • CSA
  • GAMP 5-based verification approach

Quality systems

  • Deviations
  • CAPA
  • Change control
  • SOPs

Equipment

  • Solid dosage equipment
  • Packaging equipment
  • Secondary packaging for parenterals
  • HVAC
  • Compressed air
  • Purified water

Regulations & official guidelines

  • EU GMP Annex 15

    Annex to the EU GMP Guide setting out requirements for the qualification and validation of equipment and utilities

  • PIC/S GMP Guide (PE 009)

    GMP guide used by PIC/S participating authorities, including an annex equivalent to Annex 15

  • 21 CFR Part 211

    US cGMP regulations for finished pharmaceuticals

  • EU GMP Annex 11 / 21 CFR Part 11

    Requirements for computerized systems and electronic records

  • ICH Q9(R1)

    Guideline on quality risk management, the basis for risk-based decisions

Industry standards & guides (not legal requirements)

  • ASTM E2500

    Standard guide for a science- and risk-based approach to the specification, design and verification of manufacturing systems and equipment

  • ISPE Baseline Guide Volume 5

    Practical guide to commissioning and qualification

  • ISPE GAMP 5

    Practical guide to a risk-based approach to compliant computerized systems

  • ISO 8573-1

    International standard for compressed air purity classes

We help structure technical decisions based on these regulatory requirements and industry guidance. Industry guides are not legal requirements. We do not guarantee regulatory compliance or inspection outcomes; final decisions are made under your quality assurance system.

Examples

Example deliverables and technical support

General examples of the support you can request. They do not describe work for specific clients.

  • URS review

    We check that requirements are verifiable and that quality-related requirements are clearly identified, and compile our findings in a comment log.

  • Defining test scope

    Using the risk assessment results, we separate what is verified in qualification from what is verified in commissioning.

  • Protocol review

    We check that acceptance criteria, test methods and record formats trace back to requirements.

  • Leveraging vendor documents

    We define the conditions for leveraging FAT and SAT records in IQ and OQ, and help you reach agreement with QA.

For a document review, for example, we provide a log of findings with the reasoning and recommended actions. Below is a fictitious example for illustration.

URS review comment log (fictitious example)Subject: fictitious tablet printer (sample)
No.URS itemCommentCategoryRecommended action
14.2 Printing speed: shall print at high speedNo measurable value is defined. Rewrite this as a verifiable requirement.ReviseDefine it numerically, e.g. “print defect rate of 0.1% or less during continuous operation at 600 tablets/min”
25.1 Audit trail for print contentHandling of electronic records (retention, change history) is not covered in the URS.ClarifyAdd requirements for data retention and change control, and agree the scope with QA
36.3 CleanabilityProduct-contact and wetted parts are not defined, so the test scope cannot be determined.ReviseIdentify the product-contact parts by drawing number

Scroll the table horizontally. * A fictitious example created for illustration. It is not related to any actual equipment, company or project.

Suguru Matsuzawa, Representative Director of CQV JAPAN

Profile

Suguru MatsuzawaRepresentative Director

Since 2002, Suguru has worked in pharmaceutical facility engineering, covering the equipment lifecycle from construction and start-up through URS, risk assessment, DQ, FAT, IQ, OQ, PQ, technology transfer and GMP compliance.

He has worked on C&Q from three perspectives, at a general contractor, at pharmaceutical manufacturers and at a CQV engineering consultancy, covering solid dosage equipment, packaging lines, secondary packaging for parenterals, and utilities such as HVAC, compressed air and purified water. He has also prepared technical documents in English and led meetings with overseas sites.

Experience
24 years in pharmaceutical facility engineering & CQV (since 2002)
Perspectives
General contractor / Pharmaceutical manufacturer / CQV consultancy
Core areas
URS, risk assessment, DQ/FAT/SAT/IQ/OQ/PQ, technology transfer
Languages
Japanese (native), English (technical documents & meetings)

This describes our representative's personal experience. Names of former employers, clients and projects are withheld for confidentiality.

Process

From inquiry to kickoff

  1. 01

    Inquiry

    Send us the equipment, project stage and your question using the form below.

  2. 02

    NDA

    Where needed, we sign a non-disclosure agreement before reviewing specific documents.

  3. 03

    Initial call

    We discuss your situation and objectives online and define the scope.

  4. 04

    Proposal & quotation

    We propose spot consulting or monthly advisory, with the scope, duration, deliverables and fees.

  5. 05

    Agreement & kickoff

    Support begins according to the agreed scope and schedule.

FAQ

Frequently asked questions

What kinds of companies do you work with?

We work with the engineering, facilities and quality functions of pharmaceutical companies, as well as pharmaceutical equipment suppliers and engineering firms.

Can we consult you in the middle of a project?

Yes. We can start by reviewing documents you have already prepared, or by working through open issues during test execution.

Which should we choose, spot consulting or monthly advisory?

Spot consulting suits a defined issue or document. Monthly advisory suits projects that run for several months where you want ongoing support. We will suggest the best fit during the initial call.

How much does it cost?

Fees depend on your request, the volume of documents, the duration and the frequency, so we quote individually after the initial call.

Can you work with English documents and meetings?

We have experience preparing and reviewing technical documents in English and in meetings with overseas vendors and global teams. We will confirm the scope of support based on your needs.

Do you guarantee compliance in regulatory inspections?

No. We provide technical advice based on the relevant guidelines and hands-on experience. Final decisions are made under your quality assurance system.

Contact

Request a CQV Consultation

Please include your question and the stage of your project. We will review it and get back to you, in English or Japanese.

  • For corporate clients
  • Fees are quoted individually
  • Please do not include confidential information at this stage
Service of interestRequired

Tell us about the equipment or process, timing and the challenges you face. Please do not include confidential information.

Request a CQV Consultation