Brief introduction of Quality
Assurance system in Zhejiang Xianju Pharmaceutical Co.,
Ltd |
1.organization and establishment
Company sets up the Quality Assurance Department. It is led directly
by General Manager and responsible for the quality manager of
overall process and organizes the implement of GMP. General Manager
charges the quality management work of the enterprise. He is senior
engineer, licensed pharmacist and with rich practical experience
of drug production and quality management. He has strong managing
ability to deal with practical problems during the drug production
and quality management. Quality Assurance Department is composed
of QA and QC. The number of personnel is adapting to the requirement
of production. QA is responsible for the quality supervision and
inspection of production overall process. QC is responsible for
the quality inspection of the raw material, supplementary material,
package material, water in the process, semi-manufactured product
(intermediate) and final product. Also it is responsible for the
observation of preserved sample and review of stability. It is
composed of raw material, intermediate and final product inspection
laboratories. All those guarantee the quality of product.
There are physics-chemistry operation room, biological assay
room, instrument room, sample preservation room and stability
laboratory in the raw material and final product inspection laboratories.
They are equipped with high performance liquid chromatograph,
gas chromatograph, ultraviolet specteophotometer, infrared spectrophotometer,
automatic potentiallmeter, automatic indication polarimeter, granule
calcimeter, moisture teller and scores of advanced detection facilities.
In-process control laboratories are set up in every plant. They
have operation room and instrument room. The usable floor space
of QC laboratory is 2000m3. Its detection facilities is adapting
to the production scale and inspection requirement.
2. the quality control and product quality status in
the production process
Company has established perfect Quality Assurance system. It
constitutes ¡®Quality audit procedure of the supplier¡¯, ¡®check,
accept, store and usage management regulations of the stock material¡¯,
quality specification of every material, process regulation of
every product and operation method. And it executes them strictly.
Every product has established integrated batch production record
and sale record and can be traced back. Rejects are managed strictly.
It constitutes ¡®Rejects treatment procedure¡¯ and executes it strictly.
It deals with the quality complains and adverse reflections timely.
Company constitutes the review system of preserved sample and
quality stability in order to know the steady circumstances of
the market. In these years, the product quality of our company
is stable and acceptability of spot test in the market is 100%.
So we have favorable market report.
3. about GMP authentication
In recent years, the GMP authentication of company makes big
progress. All types of formulations and APIs have passed the GMP
authentication of SDA. It establishes a solid base for future
development of the enterprise.
About GMP authentication of the company£º
| About domestic GMP authentication |
| Scope of authentication |
Authentication time |
Certificate No. |
| Freeze-drying injection |
Nov. 2000 |
B0540 |
| Dexamethasone Sodium Phosphate; Dexamethasone Acetate |
Dec. 2001 |
C1235 |
| Small capacity injection |
Sep. 2002 |
D1798 |
| Troche; Hard capsule; Prednisone Acetate, Mifepristone and
other 15 products |
Feb. 2003 |
E2318 |
| Soft capsule |
Feb. 2003 |
E2317 |
| About International GMP authentication |
| Vecuronium Bromide passed FDA In July, 1999.
|