Ruili鈥檚 quality system functions as a filter on every level to ensure our products are of excellent quality and exceed the requirements and specifications of our customers and their governments. As an American managed company, we place extreme importance on ensuring all of our products meet the highest standards of quality.
Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. Ruili's quality system is divided into 4 areas which are constantly micromanaged: Production, Distribution, Inspections, and Quality Control. Each area has unique processes and procedures to ensure product consistency.
Good Manufacturing Practice (GMP) is the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use and as required by governments. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, Ruili is most concerned with protecting the end user and avoiding risk due to inadequate safety, quality or efficacy.
Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. Ruili's record speaks for itself - no patient adverse effects reported due to poor product quality. All of our manufacturing operations are designed to exceed the accepted norms of GMP. Our customer's distribution channels and supply chains follow quality assurance as well in order to ensure our end users are getting quality medicines.
Inspections are part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture and importation of specific pharmaceutical products by foreign health ministries and drug administrations. Ruili frequently conducts both internal and third-party inspections to monitor the quality of both manufacturing facilities and pharmaceutical products in distribution channels, from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of counterfeit drugs.
Quality Control
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. Ruili's procedures range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (good laboratory management practices, models, etc.) for Certificate of Analysis and lists of laboratory equipment, and an external assessment scheme.