• Regulatory Compliance
  • Quality Assurance



ISO/IEC 17025


PIC/S Annex 11 - Computerized System

According to GMP and ISO/IEC 17025 standard

Compliance with GMP, ISO/IEC 17025 specifications

GMP Laboratories compliant with EMA, FDA and NMPA , received more than 50 audits from different customers or regulatory agencies in 2018, all of which passed the on-site inspections.

Projects carried out in GMP meet the requirements of NMPA, FDA and EMA.

Provide reports that meets the regulatory requirements of China, the United States and the European Union.



  • Team
  • Experience
  • Solutions

There are more than 100 professional technicians of which master's degree accounted for more than 60% and many doctoral level R&D personnel in the team with years of experience in project practice and R&D experiments.

There are nearly 1000 compatibility project experiences, including ampoule bottle, cillin bottle, card bottle, pre-filling syringe, oral preparation bottle, aluminium bottle, plastic bottle, plastic bag, filter core, silica gel tube, ultrafiltration membrane bag, disposable reaction bag, etc. Impurity research covers nearly 60 kinds of elements and 15 kinds of genotoxicity impurity testing methods; Structural confirmation research covers more than 500 kinds of original materials. Drugs, impurities and intermediates, etc.

The technical team  has rich capabilities in scheme design, method development and validation, and analysis of unknown substances. WEIPU Bio-pharmaceutical Division assigns a project manager for each project to ensure that the needs of the enterprise can be quickly responded to and solved. WEIPU Bio-pharmaceutical Division has outstanding technical strength and spare no effort to cooperate with the project, so that more and more pharmaceutical enterprises come into us, choose us and trust us!

In terms of package compatibility, we have established a professional database containing elastomers, PC, PVC and other materials: a total of more than 500 common additives, including antioxidants, plasticizers, lubricants, inks, vulcanizates, etc.
In the field of genotoxic compounds, we have studied more than 50 genotoxic impurity compounds, covering 15 categories, including N-nitroso substitutes, alkyl or phenyl sulfonates, haloalkanes, organic amines, nitro-substituted aromatic compounds, carbamates, acyl chlorides, etc.
In the aspect of safety evaluation of medical devices, we always follow the changes of international regulations. Years of experience in unknown compounds analysis make us more advantageous in unknown leachable analysis. WEIPU YIYAO haS developed hundreds of methods for identifying and quantifying trace unknown leachables, which provide more advanced solutions for safety evaluation of medical devices.

Areas offocus


WEIPU YIYAO has been devoted to EL research for nearly 10 years, and is a professional organization in the field of package compatibility Study.

WEIPU YIYAO has been focusing on the quality research of drugs and impurities, as a partner of the quality research profession in the pharmaceutical industry.

WEIPU YIYAO dedicated to explore the technical route of safety evaluation of medical devices, and constantly study and innovate the safety evaluation of medical devices.

Because of concentration, so professional; because of professional, so confident!



  • Hardware and Software
  • Database
  • Instruments

Personnel:  Authorized after adequate and assessment

Equipments: Implement risk-based full lifecycle management, externally calibrated, 3Q confirmed, USB limited.

Software: Empower CDS, OpenLab CDS and other analysis software with audit trail, automatic sampling, implementation domain control, file deletion prevention, physical isolation from external network, advanced one-to-one account management system, authority classification to ensure data logic security, authenticity, reliability and traceability.

Disaster Recovery System: Global Advanced Backup System (VERITAS), with Server and stand-alone version for Full Backup + Incremental Backup + Remote Backup, all data stored for at least 8 years.

Power supply system: power failure alarm system with UPS power supply and power generation by generator, to ensure business continuity.

Environmental monitoring system: laboratory and refrigerator environment ensured with calibrated monitoring equipments, validated environmental conditions, automatic recording (10min/time) and automatic alarm.

Access control management system: different experimental areas with different access rights allocation, physical isolation, and security management.

Special Drug Management: The special drug room which has passed the acceptance of public security and safety supervision is managed according to the five principles of double acceptance, double custody, double receipt, double locks and double principal accounts, so as to ensure the legality and compliance of the use of special drugs.

Document management: independent archives, access control, project independent files, archives kept for at least 8 years.

LIMS system:Thermo Fisher SampleManager

WEIPU YIYAO Served more than 500 enterprises (pharmaceutical enterprises/CRO/R&D institutions, etc.). There are nearly 1,000 established trace substances testing methods with years of experience in project practice and R&D experiments, including antioxidants, plasticizers, lubricants, inks, vulcanizates, various conventional impurities, genotoxic impurities, leachable substances of medical devices, etc.

WEIPU YIYAO is equipped with a large number of precision instruments and equipments, including:

Bruker 400 MHz NMR spectrometer, AB Triple Quad 4500 UPLC-MS/MS, Waters ACQUITY UPLC I-Class Plus-xevo TQ-S micro UPLC-MS/MS, Agilent 7890B/5977B GC-MS, Waters ACQUITY UPLC I-Class Plus/PDA/RI/ELSD UPLC, Agilent 7000D GC-MS/MS, Agilent GC-Q-TOF, Agilent LC-Q-TOF, Pekin Elmer NeXION 1000 ICP-MS, Ion Chromatography, Infrared Spectrometer, Ultraviolet-Visible Spectrophotometer, AAS, TA, DSC, Scanning Electron Microscope, etc.. These instruments can be used for rapid API The development and validation of analytical methods , can meet the requirements of instrument for qualitative and quantitative analysis of trace substances, and achieve the analysis requirements of package compatibility, genotoxicity and element impurity analysis, medical device research, R&D analysis and testing with high quality.