Quality
Built into the process.Carried through every batch.
A pharmaceutical quality system supporting GMP manufacturing, testing and site batch release in Japan. Quality Assurance and Quality Control are involved from technology transfer through routine commercial supply.
Quality management systems
Clear requirements. Consistent execution.
Our quality system provides the framework for consistent manufacturing, testing, documentation and release of pharmaceutical products across the manufacturing lifecycle.
Quality Assurance
Batch documentation and release, deviation and CAPA management, change control, quality risk management and oversight of GMP operations.
Qualification & Validation
Equipment and facility qualification, process validation, cleaning validation and support for analytical method transfer and verification.
Materials & Suppliers
Incoming material controls, supplier qualification and management, sampling, testing and documentation.
Documentation & Training
Controlled GMP documentation, procedures, records and role-based training for consistent execution.
Our role is to establish clear quality requirements from the outset and ensure they are applied consistently throughout the manufacturing lifecycle.
Technology transfer & product introduction
Quality involvement starts with the transfer.
Together with the customer and our technical teams, QA and QC define and transfer the quality framework before commercial manufacturing begins.
- Stage 01
Transfer
Specifications, analytical methods, sampling requirements and acceptance criteria.
- Stage 02
Validation
Validation activities and product-specific controls.
- Stage 03
Commercial supply
An efficient transition into routine GMP supply.
- Stage 04
Ongoing quality oversight
Change control and continuing product support.
Quality control
In-house laboratory capabilities.
Testing in compliance with domestic and international regulations (PIC/S GMP, ICH): raw materials, in-process and finished products, plus selected testing for partner products. Analytical scope and methods are agreed for each program during transfer.
Testing services
Physicochemical testing
Compliant with JP, JPC, Japanese Standards of Quasi-drug Ingredients, JPE and JSFA.
Microbiological testing
Environmental monitoring, potency and microbial limits (non-sterile).
Stability testing
Long-term and accelerated studies based on PIC/S and ICH.
Laboratory equipment
Customer quality interface
Customer audits are welcome at any stage.
Before and during an engagement. Responsibilities and interfaces are defined for each program in the applicable Quality Agreement.
Discuss your quality requirements- Product transfer and documentation
- Deviations and investigations
- Change control
- Validation activities
- Ongoing product support
Our teams work directly with your Quality organization on each of these.