Quality control

Quality Guideline:
Sincere desire for client, secure and effective protect health, technology innovation promotes development.

QA.
Mainly in charge of preparation, checking and supervising of documents, releasing of finished products, suppliers' audit, GMP self-inspection, product complaint and disposal of returned goods, and coordinating with all campaigns related to product quality.

QC-LAB.
Cheng Yi Pharmaceutical Co., Ltd. has an advanced and modernized analytical laboratory equipped with reliable advanced modern analytical instruments and devices that are operated by our experienced and highly qualified team of analytical chemists. Our manufacturing, R& D, and the quality assurance system are strongly supported by our analytical capabilities. Major analytical instruments as follows:

High Pressure Liquid Chromatography (HPLC); Difference Scanning Counting (DSC); DL53 Automatic Electronic Titrimeter; DL38 Karl Fischer Water Titrimeter; Thin Layer Chromatography; Infrared Spectrometry; Gas Chromatography; UV/VIS; Polarimeter; TOC-2000; Incubators; Titration; Elementary Analysis; Optical Rotation; Atomic Absorption; Thermal Analysis; Microbial Ingress Testing; Stability testing; Total Organic Carbon Counting.

Certificates

ISO9001
1. Quality management is the core of GMP. The company performs the policy of "Preventive first and quality control for the whole process".
2. Personnel are the first factor to determine the product quality, therefore, GMP training for all the employees is of the first importance.

REGULATORY COMPLIANCE
Since 1997, Cheng Yi Pharmaceutical Co., Ltd. has been implementing the cGMP operation system. The overall production facilities and the quality assurance systems have been improved and fine-turned to meet the strict international regulatory requirements or customers requirements. All employees have been receiving regular long-term full training of cGMP and technologies since 1997. We often invite the experts from domestic and overseas to give us the lectures, advice or on-site training class. In Dec. 1998, Australia TGA audited and approved our cGMP operation systems, and reviewed in Apr.2002 and Mar.2006. In Nov. 2001, China SDA inspected and approved our GMP system and awarded with GMP Certificate. In Jan. 2002, Cheng Yi Pharma was accredited with both ISO9001 and ISO14001 Certificates. Further, in the recent years, we have satisfied auditors from many major multinational pharmaceutical companies.

Certificates

CEP	EMEA	FDA	GMP
ISO9001	ISO14001	MEXICO	MHRA
TGA