Quality evaluation

We will provide overall services to support our customers' quality evalution activities.

We support any work in terms of pharmaceutical quality control and evaluation, not only quality control work necessary for production activities, but also exposure monitoring for operators and wastewater analysis. Our sufficient knowledge of PIC/S GMP, J-GMP, c-GMP and EU-GMP satisfies your needs.

One Stop Service

We can handle any kinds of quality control testing covering raw materials to final products. Speedy delivery of accurate test results is guaranteed.

Innovation

We help in realizing work environment where all medical and other staff feel safe to work. We also support analysis work to protect natural environment.

Regulation

We provide quality evaluation work for all aspects of pharmaceuticals in accordance with international standards.

Quality Control Testing

Monitoring of Exposure to
High Potency Materials

Environmental Analysis

Analytical Instruments /
Owned Facilities

Quality Control Testing

We can conduct full range test from release testing to stability testing of investigational new drugs and commercial pharmaceutical products. We guarantee speedy delivery of highly reliable data.

・Our specially trained staff can conduct accurate tests, such as physicochemical and microbial tests according to the various official compendia and test methods. For available tests, please see the equipment list. Please feel free to contact us for not listed tests.

・We can also provide various services such as stability testing according to the international regulation (ICH) (here are the available storage conditions), and storage of samples and reference standard management. We are fully prepared for troubles in the sample storage due to natural disasters or abnormalities. We have a back-up power system and an emergency contact system even during holidays and weekends.

Monitoring of Exposure to High Potency Materials

By monitoring high potency materials in the work environment during production activities, we can support creating the safe working environment for all operators.

・Proposal of sampling plans based on risk assessment

・Monitoring of exposure and scattering of high potency materials (Capable of measuring high potency materials of more than PDE 0.001mg/day, and more than OEL 0.1 ug/m3)

Environmental Analysis

We provide services for measurements within work environment and wastewater analysis that are responsibilities required of entities that are permitted to operate as environment measurement certification and work environment measurement certification business.

・Environmental Analysis (Environment Measurement Certification Business, Work Environment Measurement Business): From test planning phase, we can support analysis work such as analyzing wastewater discharged from plants and laboratories and measurement of work environment mainly of organic solvents at API manufacturing and chemical R&D facilities.

Analytical Instruments / Owned Facilities

Analytical Instruments

To respond to a wide range of customers' needs, we have a variety of test instruments that are listed in the Japanese Pharmacopoeia.

Physiochemical Test Instruments	Liquid Chromatograph (HPLC, UPLC) Ion Chromatograph Nuclear Magnetic Resonance Spectrometer (NMR) Powder X-ray Diffractometer Atomic Absorption Spectrophotometer Infrared Spectrophotometer Elusion Tester Refractometer pH Measuring Instrument Total Organic Carbon Measuring Instrument Melting Point Measuring Instrument Water Content Measuring Instrument Potentiometric Titrator Particle Size Analyzer Tablet hardness Tester	Liquid Chromatograph Mass Spectrometer (LC/MS/MS) Gas Chromatograph Inductively Coupled Plasma Mass Spectrometer (ICP-MS) Inductively Coupled Plasma Emission Spectrophotometer (ICP) Ultraviolet and Visible Spectrophotometer Kjeldahl Nitrogen Measuring Instrument Disintegration Tester Osmometer Polarimeter Conductivity Meter Viscometer Water Activity Measuring Instrument Specific Surface Area Measuring Instrument Light Shielding Automatic Particle Measuring Instrument Other
Microbial Test Instruments	Aseptic Test Isolator Endotoxin Measuring Instrument EO Gas Sterilizer	Genetic Analysis Instrument Airborne/Floating Bacteria Count Measuring Instrument Other

Sample Storage Equipment

The temperature and humidity of all storage equipment are centrally controlled.

Sample Storage Vault	Low temperature constant temperature chamber (Reach in Chamber) Photostability testing equipment Prefabricated thermo-hygrostat chamber (Walk in chamber) Ultra-low temperature storage vault

Storage conditions can be tailored for both temperature and humidity, so please contact us with your needs.