Our global quality system are designed to ensure that product quality meets applicable GMP requirements at every stage of the product’s lifecycle by using scientifically sound design, processing methods, and testing procedures.
We are committed to adhering to all global regulatory standards, and comply with ICH Q10 guidelines, NMPA GMP, EU GMP, and US FDA GMP requirements. Our quality control labs support the entire drug development and manufacturing process from pre-production readiness, quality control, product release, storage, and transportation.
We are committed to adhering to all global regulatory standards, and comply with ICH Q10 guidelines, NMPA GMP, EU GMP, and US FDA GMP requirements. Our quality control labs support the entire drug development and manufacturing process from pre-production readiness, quality control, product release, storage, and transportation.
Quality Control
Laboratory Equipment
State-of-the-art testing equipment includes HPLC, UPLC, FQ-PCR, FT-IR spectrometer, capillary electrophoresis apparatus, flow cytometer and isolator.
Testing Capabilities
Our world-class operations feature advanced equipment and instruments as well as highly trained professionals to provide our clients with high-quality services covering raw material, in-process control, product release, and stability testing. Procedures are in place to ensure that incoming materials, in-process samples, finished products, and stability samples are tested in compliance with pre-set specifications. Our robust monitoring and maintenance program ensures the facilities and equipment remain in a state of control.
Quality IT systems
Advanced GMP computerized systems such as SAP, MES, TrackWise, E-Doc, LIMS, Empower, EMS, PMS, LabWatch, DCS, PCS7, etc.
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