Huatai Biopharm Inc.- Omega-3 Fish oil

Quality Assurance

Quality Control

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Huatai Quality Assurance System plays an important role in assuring that the company can provide ultra purirified and high concentrated omega-3 fatty acids and services expected by its customers

Quality Assurance is a commitment to excellence by each Huatai employee. It's achieved through teamwork and a process of continuous improvement

Goals

Quality affects all segments of the company. It means providing our customers with products and services to meet their needs. Customer satisfaction is therefore a key element in our definition of quality. In improving the quality of our products and services, the Quality Assurance System is set so that the improvements achieved can always be measured. In this way, we are able to meet three of our key goals:

Increasing the efficiency of our operation processes and procedures
Minimizing the need for corrective actions
Ensuring the high quality products and servieces to our customers

Meeting these strategic goals is a key prerequisite in improving the quality and competitive position of our products and services in world markets.

Leadership Responsibility

The leadership of the company holds special responsibility for the continual improvement to the quality of our products and services.

It develops and promotes the quality awareness of the workforce.
It works with all parties involved to define quality objectives and ensure that these are met.
It creates the organizational and personnel framework for meeting the quality objectives.
It ensures that all employees receive the necessary training to enable them to meet the set quality objectives.

Quality Management Dept.

The organisational units of the company are supported by the Quality Management Department in meeting the quality objectives.

The main functions of the Quality Management department are:

Defining company-wide quality strategies and objectives; issuing quality management regulations binding on all organisational units; conducting regular information sessions for the quality officers of all organisational units
Promoting quality management training for all employees; working in external committees and working groups
Quality management is the responsibility of the organisational units. They define quality policy and ensure the development and implementation of appropriate and effective quality systems to conform with

Raw Materials

In a certain degree, good quality of raw material means good quality of finished products, Huatai only use good quality crude fish oil to produce high purity Omega-3H^TM oil. Our crude oil comes from the deep-sea fish species mainly in Peruvian and Chilean coasts, which is the cleanest ocean area in the world. The crude oil from above coasts means the lowest level of PCB, dioxins and organic pesticides residual. The qualified raw material source combined with our unique purification technologies and professional quality assurance management forms the basis of our excellent Omega-3H^TM fish oil.

To gather the qualified suppliers and best raw material resources world-wide together, Huatai made hard efforts on screening and identification among over 20 factories/supplier and finally chose only a few of them into its Supplier Source Database (SSD), in which all of them are approved to be qualified suppliers for certain product(s) or services through the following sourcing and identification program:

Gathering the general and basic information of the factories.

Reviewing and checking the production facilities and workshop environment of the factory by our professionals, collecting all the data and records for COA, production, management, quality and cost control in the last 3 years.

Taking 10 random samples with COA from different batches within the latest one year for our lab’s full inspection and analysis; so as to get full data of product quality information.

Comparing and evaluating all the data collected and making a decision if the factory is a qualified supplier to our Supplier Source Database (SSD).

Updating the SSD annually according to our business experience with these suppliers.

Procurement

Huatai has estabilished and maintained scientific and efficient procurement programs which ensure that services procedures and purchased goods are controlled to conform to the specified requirement.

Because purchased goods and services directly affect the quality of Huatai's products and services, according to the company's procurement program, all our procurements are published only to the appropriate suppliers in our Supplier Source Database (SSD) to ensure the best quality and the most competitive price. Efforts are specially made to establish a close working relationship and feedback system with suppliers to assure the highest value in terms of quality.

Inspection and Testing

To ensure the quality products and services to our customers, we set up our own research and analyzing center (Lab.) that has been equipped with the top-class inspection facilities, such as GC, HPLC, TLC, UV and etc. to act as the role of quality control, which was set through over each step of production and logistic process based on company Quality Assurance System.

Huatai Biopharm also cooperates with world-class Laboratories, such as Urofin, for regular comparative analysis, especially in PCBs, Dioxins-like PCBs contracting-inspection

Control of Nonconforming Product

Documented procedures are established for the identification, isolation, tracking, evaluation and disposition of nonconforming product to prevent its unintended shipment.

Handling, Package, Storage and Delivery

Documented procedures are established and maintained for handling, storage, packaging, preservation and delivery of materials.

Huatai's products are stored and distributed in such a way that the following product requirements are met:

Quality conforms with requirements and inspection status is clearly indicated.
Product grades are clearly and correctly marked.
Product is stored, handled and delivered in a manner that meets customers' requirements.
Product is stored, handled and delivered in a manner that prevents damage or deterioration.
Product is loaded and delivered in an inspected and safe vehicle.

All HUATAI's product packaging is designed to:

Protect personnel who come in contact with the package.
Maintain the integrity and quality of the product.
Ensure product identification and easy traceability.
Meet or exceed regulatory, environmental and/or customers' requirements

HUATAI packaging requirements apply to all products that are handled or stored within its facilities and contract locations.

Records & Database Management

Records & Database Management System are established, maintained and controlled to demonstrate effective operation of the total management system and conformance to requirements.

The Departments that generate quality records are responsible for ensuring their appropriate storage and retrieval. Record management personnel are responsible for periodic auditing to ensure compliance with Records Retention Guidelines.

Supervision

Each organization conducts periodic supervision to verify that work activities are consistent with defined management systems, and to ensure that management systems remain effective for achieving objectives and targets.

Periodic quality audits are conducted to:

Ensure all procedures and operations are complying with HUATAI's internal quality standards and external regulatory requirements.
Determine the effectiveness of company's Quality Assurance System.
Ensure that HUATAI's products and services meet customers' requirements.
Identify opportunities for continuous improvement

Training

Corrective and preventive action documented procedures are maintained and implemented for all identified incidents, unplanned events and nonconformances associated with this quality management system.

Product and/or service problems are documented to permit:

Analysis of the cause(s) of unacceptable product or service.

Determination of the action needed to prevent reocurrence, and follow through.

Documentation of corrective action taken and resulting changes to system procedures.

Validation of the effectiveness of corrective and preventive actions.