CQV Consulting
We support the commissioning and qualification of pharmaceutical manufacturing equipment in Japan, from early planning through test execution. We also take on specific parts of a project.
Situations
Scope
We organize the qualification approach, document structure, roles and responsibilities, and schedule according to the size and risk of your project.
We check that the requirements needed for product quality and operation are written in a verifiable way.
We identify quality-critical functions and components and document the rationale for the depth and scope of testing.
We review protocol and report structure, acceptance criteria and traceability to requirements.
We support design reviews, commissioning, FAT, IQ, OQ and PQ execution while coordinating with vendors and contractors.
We support the planning and management of equipment qualification, from URS to PQ and process validation, for product and process transfers.
For control and data systems embedded in equipment, we help define a risk-based verification approach aligned with GAMP 5. The scope of support is confirmed case by case.
Lifecycle stages we support
URS
User requirements
SRA
Risk assessment
DQ
Design qualification
FAT/SAT
Factory / site acceptance
IQ
Installation qualification
OQ
Operational qualification
PQ
Performance qualification
PV
Process validation
Approach
We use risk assessment to identify quality-critical functions and components and to set the scope and depth of testing.
We make it possible to trace how each URS requirement is met in the design and verified in testing.
We clarify the roles and procedures of vendors, contractors and quality functions so that the plan can be executed as intended.
* Our services consist of technical advice and practical support and do not guarantee compliance in regulatory inspections. Final decisions are made under your quality assurance system.
Pricing
C&Q planning, review of URS, protocols and reports, risk assessment, and on-site technical support, as much as you need.
Main factors in the quotation
For ongoing support with a defined duration, resourcing and deliverables, we provide an individual quotation after understanding your needs.
* The specific scope, number of days and deliverables are quoted after we understand your request. We will also explain how travel and accommodation costs for on-site support are handled when quoting.
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.
