QUALITY POLICY


Lean & Leap Pharmaceutical adheres to the purpose of "High Standard Quality Control for Benefit of Human Health"

and advocates the concept of "Quality-Oriented, Safe and Effective".

We undertake to comply with the laws and regulations of drug management, ensure that drugs meet the requirements of intended use and registration, establish and promoting quality risk management, continuously improve the quality management system,

constantly reduce product quality risks, and implement effective training, and constantly improve quality sense and level.

QUALITY MANAGEMENT SYSTEM

The quality management system of the Company is directly led by General Manager of the Company, which is independent of the production system, and the Quality Director shall perform the quality management function on behalf of the general manager.

The Quality Director is the person in charge of enterprise quality management and the authorized person of quality. The Company has Quality Assurance Department, Laboratory and International Registration Department.

01\ONE

Department is involved

in all issues related to quality and is responsible for the effective monitoring ofThe Quality

Assurancethe whole process involving product quality activities.

02\TWO

The Laboratory is responsible for the effective monitoring of the whole process of product quality control. Subordinated to the Lab, there are Lab of Raw Materials & Finished Products, Central Control Lab and Central Control Lab of Preparation Workshop.

04\FOUR

The Quality Director of the Company shall authorize the quality person in charge of each sub-plant area to

directly control the quality system of

the sub-plant area.

All the sub-factory areas shall have quality management departments.

03\THREE

International Registration

Department is responsible for organizing products, foreign registration of foreign drug administration laws

and regulations and foreign customers technical support work.

Quality Assurance

and Inspection Team

The Company has established a perfect quality management system and formulated a series of SOP which are all strictly implemented. All operations are recorded and traceable; timely and effective customer quality complaints and product recall procedures are established. Verification management, change management, deviation management, risk management and so on run through the whole life cycle of the product. For many years, the quality of our company is stable, the qualified rate of market acceptance is 100%, and the company enjoys a good market reputation.

In addition to strictly management of the production in accordance with the relevant sop, the Company is also equipped with advanced testing equipment such as high-performance liquid chromatography,

liquid mass spectrometry to implement the intermediate control of production process and test of finished product release.

The Company also has a special quality research team, carries out the development

and verification of inspection methods, and quality research work including impurity separation, identification, tracking, etc.

The commonly used analytical instruments available in the company are as follows:

LC-2030C High Performance Liquid Chromatograph:

produced by Japan Shimadzu Corporation, used for determination of the content of raw materials, auxiliary materials and finished products and determination of related substances.

Gl-10 Polymer

Impurity Detector:

produced by Shanghai

Kezhe Bio-tech Co., Ltd.  

used for the determination of polymer.

GC- 2014 Gas

Chromatograph:

produced by Japan Shimadzu Corporation,

used for the determination of residual solvents for raw materials and excipients, etc.

AA-7000 Atomic

Absorption Spectrometer:

produced by Japan Shimadzu Corporation, used for the determination of chromium in heavy metals such as hollow capsules

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