Quality Management Team
We have perfect pharmaceutical production and quality management organization, pay great attention to SME training of each field, and own a quality management team which is professional and keeping improving.
Overall Quality Risk Management
Quality risk management is applicable for the whole life cycle of the products. Project quality risk management evaluation is carried out every year. The evaluation scope covers buildings and facilities, equipments, materials and products, qualification and validation, production management, quality control and quality assurance, product delivery and recall, etc.. The risk management concept is integrated into each activitiy of quality management.
Supplier audit and evaluation to ensure the quality from the source
All the suppliers are subject to strict audit and evaluation by Quality Department. Materials should only be purchased from the approved suppliers. Evaluations of suppliers are given on the basis of data of analysis and stability study, trial results and site inspection results. Retrospective quality analysis is performed every year to ensure the consistent quality supply.
Stringent production management
The whole production is strictly processed in line with the process instruction, post SOPs, and corresponding standards and procedures. The production areas are cleaned before production of every batch to ensure the safe and orderly production.
Validation management system
The validations are conducted according to the requirements of Chinese GMP (new version), EU GMP, ChP, Ph.Eur., BP, USP, referred to advanced industrial standards of international institutions such as WHO、PIC/S、ISPE、ISO etc., and are with international advanced validation methods and standards.
The QA personnel give strict inspection and supervision, throughout the production process, on the quality control spot, hygienic control and environment real-time dynamic monitoring of clean areas, putting the quality fluctuation efficiently and promptly under control.
Deviation and change control
The deviations to production process, reconciliation, specification, analysis methods and standard operating procedures etc. are recorded. The deviations raised during production, validation and testing process are handled as per relevant SOPs. Every deviation is subject to evaluation of its impact on quality and timely disposal afterwards. Effective CAPA is employed to prevent the same deviation from happening again. The training on deviation management is paid high attention to improve the ability to discover deviations and strengthen the awareness of reporting the deviations.
Change control system has been established. All changes that may affect the product quality should be subject to quality risk assessment and management in accordance with SOPs, to ensure the change won’t affect the product quality and ensure the change conforms to the requirements of the current in-house standard and GMP.
Data reliability management
The study on data reliability guidelines of MHRA, WHO, FDA, PIC/S, EU and the CFDA etc. has been organized, and the special training has also been organized to improve the awareness of data reliability of the whole company. Meanwhile, self-checking and SME training are organized to deepen the data reliability management and create an honest enterprise culture.
Test instruments and test capabilities
QC lab covers an area of about 2500 square meters, equipped with imported precision instruments and equipment such as infrared spectrophotometer, high performance liquid chromatograph, gas chromatograph, ultraviolet spectrophotometer, atomic absorption spectrometer etc. In which, chromatographic system has been upgraded to network version to manage the the computerized systems and electronic data more strictly and effectively. Clean area of QC lab has seven independent HAVC systems, three for aseptic sampling systems, one for sterile test system, one for microbial limit examination system, one for positive examination system and one for Grade D auxiliary system, which meet the demand of aseptic sampling and microbiological examination and could avoid cross contamination as well. QC lab was designed in accordance with the requirements of product process, and has rational layout and complete function. The facilities, personnel and instruments could meet the requirements of the quality control. The analysis methods are in accordance with ChP, the USP, EP and other advanced standards. QC Lab has modern quality control abilities and could meet the requirements of full inspection.