Documentation
Documentation is an essential part of quality system, QA department is responsible for preparing and auditing all the documents according to criteria and standards concerning quality management, this includes documents for the specification of each raw materials and intermediate and semi finished products and finished products as well as detailed testing methods as per pharmaceutical formulation.
All actions pertaining to manufacturing of pharmaceutical formulations are documented and reviewed regularly and updated, These includes Standard Operating Procedures (SOP)for performing various operation, such as SOP for process and cleaning validation ,SOP for sampling as well as its calibration and maintainace, SOP for sampling and product retain, SOP for environmental control and water treatment, SOP for animal test, SOP for product recall, handling of products complains, stability study, and SOP for self audit, etc.
Quality Assurance
Our company strives to focus ourselves on the product quality, material cost and has accomplished the aforesaid the best combination in order to reach the goal of the customers’ satisfaction and safety toward the company's products.
Our company offers comprehensive quality assurance system ranging from product development, product design, product verification, purchasing, material incoming controls, production, process control, final product control, reliability testing, customer complaint handling of after-sales service. Our quality assurance system is focused on improving product quality, correcting operational methods and fulfilling customer requirements.
Achieving a sufficiently high level of quality doesn't just happen, it is the result of constant inspection and comparison. Every stage of production is operated and closely supervised by skilled and dedicated staff. For better quality, product inspection is carried out, taking into consideration every conceivable condition the product may encounter in its lifetime of performance.
The entire team is dedicated to meet development and mass production schedules, delivering low cost and reliable products, and providing effective customer complaint handling and after-sales service, to allow our customer to feel confident and satisfied with our products and services.
Quality Control
The highest priority has always been placed on quality. From Raw Material incoming to products shipment, we manage every step of the manufacturing process to insure products are made to the clients’ specifications. We place an emphasis on understanding the specifications and customer quality requirements, the application of the proper controls and producing the part precisely the first time. A precise and effective quality assurance system has been established and consummated gradually. A strict quality management ordinance has been put into practice to ensure the effective operation of quality management system.
Our company build the complete modern enterprise system from original research and development of products, production, sales to after-sale services. also continue to bring in first class staff in management, technology and bring in the best and latest management system in order to comprehensively improve enterprise management level, production ability and create the perfect market image. We have professional staff to ensure the product quality and the strict production process.
Quality Control Measures
- Total Quality management (TQM)
- Continuous Improvement Program
- Employee Training Programs
- Investment in the Latest Quality Control Equipment
- Quality Incentive Programs
- Organizational Commitment to Quality
Insisted that quality is our first priority , and the implementation of ISO9001 : 2000, the standardization of our
quality system and the quality stability have earned us the trust of our customers for years.
Stablility Study
We have developed a written program for stability determination which includes elements such as a complete description of the drug studied. Complete testing parameters, methods describing all tests as per the specification of each product formulation.
Accelerated and real time stability studies are performed within our company. We have sufficient accelerated stability chambers where accelerated stability studies are conducted at 30±20C/75±5%RH and 40±20 C/75±5% RH.
Real time stability studies are conducted in real time stability chamber where storage condition is set according to the need of targeted markets. The retention sample room is well maintained. Temperature and humidity is routinely checked and recorded.
Product Complaint
Company to the customer complains about and good measures.The work on visiting and complaints from
customers are done well.The company has established a related institution,procedure and record to deal with
complaints for quality and adverse effect.Countermand and recall of the unqualified products are done in
time.Immediate action to analyze the reasons of quality problem is taken,and improvements suggestion and
preventive measures will be given on due.
There are distribution records for every batch of finished products.According to the description record we can
know the related information of each drug.In order to strengthen the company's intelligence and internal control,
formulate the related complaints system,in strict accordance with the provisions of the state on the legal system.
Customers can rest assured use and supervision,to ensure the realization of the target of the management company
and the company sustained, stable and healthy development.
