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Quality Management Systems

Since its establishment, ACROBiosystems Group has been improving its quality system for over 12 years, aiming to help customers accelerate the progress of drug development and its clinical applications.

We passed ISO 9001:2015 Quality Management System Certification for the first time in 2016;

passed ISO 13485:2016 Medical Device Quality Management Systems (QMS) Certification in 2019;

established a GMP-grade product quality management system in 2021;

and passed the CNAS accreditation regarding our SPR service in 2022.

A good quality management system is continuously improved based on the evolving customer requirements, regulatory requirements, and market circumstances.

ACROBiosystems has a professional quality management team, which has extensive experience and is intimately familiar with regulations related to biomedical sciences in countries and regions around the world. By closely following industry trends, our team can rapidly establish or modify the quality management system according to various product types, customer application scenarios, and regulatory requirements. This makes it feasible to develop and manufacture products that meet the requirements of different customers and ensure that the regulatory requirements and market circumstances are met.

ISO Quality Management System

Document Management System of ACROBiosystems: Four-level "pyramid" Structure

Six Features of ACROBiosystems’ Quality Management System

ACROBiosystems has established a quality management system under the requirements of ISO 9001:2015 and ISO 13485:2016, and passed the QMS certification in 2016 and 2019, respectively. By running the system efficiently, we have ensured the management of the whole life cycle of products and services from design and development, bench-scale testing, formal production testing, marketing to customer feedback.

The risk-based thinking and design concept enables the quality system of ACROBiosystems to respectively establish management requirements for such system modules as Man (E-Learning online training system), Machine (verification and validation management system), Material (hierarchical management system of materials and suppliers), Method (four-level document structure), Environment (QA monitoring of production environment and process), and Measurement (20+ testing techniques, 30+ testing steps, 4 audits, and 3 releases), and QA personnel are specially assigned for each module. During the routine operation of the quality management system, ACROBiosystems applies multiple monitoring and measring means(routine testing/supplier performance/customer satisfaction survey/internal audit/management review/external audit, etc.) to discover the problems in real time and make improvements to ensure the effectiveness, adequacy, and suitability of our quality management system.

Product Documentation of ACROBiosystems: Four-tier

GMP Quality Management System — always under continuous improvement

Good Manufacturing Practice (GMP) is a set of standard rules formulated by the U.S. Food and Drug Administration (FDA) and adopted globally on personnel, premises and facilities, equipment, manufacturing management, quality management, and document management to produce high quality pharmaceuticals. As a set of compulsory standards applicable to pharmaceutical and other industries, GMP is the basic guideline for pharmaceutical manufacturing and quality management. It is applicable to all key processes that affect the finished product quality in the whole process of pharmaceutical manufacturing and in the production of drug substances. Pharmaceutical manufacturers are required to have verified production equipment, optimized manufacturing processes, a comprehensive quality management system, and a strict testing system. This ensures that the product quality meets relevant standards and to identify and solve problems occurring in the production process in a timely manner.

Throughout the whole process of pharmaceutical manufacturing, GMP controls the factors affecting the product quality through scientific approaches and effective measures to ensure that the quality of products consistently meets the manufacturing quality standards. GMP, a set of requirements established to prevent (especially unknown) contamination, confusion and

GMP, a set of requirements established to prevent (especially unknown) contamination, confusion and errors, is used to compensate for the limitations of final product testing.

To better support CGT-related customers, ACROBiosystems has established the GMP quality management system for GMP-grade products.

GMP Quality Management System of ACROBiosystems

Quality Management System

Manufactured and QC tested under GMP compliance
Designed under ISO 9001:2015 and ISO 13485:2016
Animal-Free materials
Materials purchased from approved suppliers
ISO 5 cleanrooms and automatic filling equipment
Qualified and well-trained personnel
Quality-related documents reviewed and approved by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files

Click here to applicate the
Regulatory Support File (RSF)

Production Qualification of Suppliers

Suppliers should pass ISO quality system certification and have an effective quality management system.

Hardware facilities such as production workshops should strictly meet the requirements of GMP regulations and provide necessary documentation such as providing audit certificates from third-party authorities, such as drug production license, GMP audit reports from well-known third-party organizations, other qualification documents, etc.

The suppliers should have advanced R&D and production technology, qualified manufacturing process and capabilities, and the capacity for continuous production and supply.

ISO 9001:2015
ISO 13485:2016
To whom it may concern