Altruist Biologics

Quality System

Our global quality system is designed to ensure product quality that meets applicable GMP requirements and also be implemented as a risk-based system throughout the different stages of a product lifecycle by using scientifically sound design, processing methods, and testing procedures to meet our customer needs. Our global quality system complies with ICH Q10 Guideline, NMPA GMP, EU GMP, and FDA 21 CFR. The quality system covers the entire drug development and manufacturing process from drug production, quality control, product release, storage, and transportation. Our quality team is committed to adhering to all applicable global regulatory standards and promoting a quality-focused organizational culture.

Quality Control

Laboratory instrument

Offer state-of-the-art testing instrument include: HPLC, UPLC, FQ-PCR, FT-IR spectrometer, capillary electrophoresis apparatus, flow cytometer and Isolator, etc.
Testing Capability

A robust system is established with state-of-the-art facilities, equipment, instruments, and 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, stability samples are tested in compliance with pre-set specifications. Our robust monitoring and maintenance program ensure the facilities and equipment remain in a state of control.
GMP Computerized System

Equipping with advanced GMP computerized systems such as SAP, MES, TrackWise, E-DOC, LIMS, Empower, EMS, PMS, LabWatch, DCS, PCS7, etc.

Laboratory instrument

Offer state-of-the-art testing instrument include: HPLC, UPLC, FQ-PCR, FT-IR spectrometer, capillary electrophoresis apparatus, flow cytometer and Isolator, etc.

Testing Capability

A robust system is established with state-of-the-art facilities, equipment, instruments, and 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, stability samples are tested in compliance with pre-set specifications. Our robust monitoring and maintenance program ensure the facilities and equipment remain in a state of control.

GMP Computerized System

Equipping with advanced GMP computerized systems such as SAP, MES, TrackWise, E-DOC, LIMS, Empower, EMS, PMS, LabWatch, DCS, PCS7, etc.

Inspection/Audit

20+
NMPA GMP

2016-2022
1
FDA RIE

2022
3
EU QP GMP

2020-2022
6
MNC Partner

2016-2021