Quality Control-Hopesailing Safety

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About us

Organization and Responsibilities

Personnel QA:4,QC:9
Personnel Structure

QA Department
Technological Professional Title		Academic Qualification
Senior Engineer	Certified Pharmacist	College	Junior College
1	1	1	1

QC Department
Technological Professional Title		Academic Qualification
Engineer	Assistant Engineer	College	Junior College	TS School
3	2	2	1	2

Responsibilities

The quality unit is divided into two departments - QA and QC.The quality unit is responsible for carrying out
sufficient quality supervising and quality control throughout the whole production process.

Documentation System

The company has established its documentation system of five layers.

The five layers are:

1.	MP: Management policy
2.	SMP: Standard management procedure
3.	STP: Standard technology procedure
4.	SOP: Standard operation procedure
5.	BPR: Batch production record
6.	REC: Other Record

Instrument in QC

In order to meet the requirements of production control and QC manegement, the company has equipped
with comparatively completed advanced analytical instrument and test equipment. Mainly includes:

NO.	Name	Type
1	IR Spectrophotometer	IR200
2	UV Spectrophotometer	UV754
3	UV Spectrophotometer	UV2102
4	AUTO Polarimeter	WXX-2B
5	HPLC	SPD-10 AVP
6	HPLC	1100
7	HPLC	1200
8	GC	689 ON
9	Potentiometrictitration	DL-50
10	Electronic Balance	AE100
11	Electronic Balance	XS105

Training

Dedicated personnel in the Management Department are assigned to be responsible for training;
Training Plan is available: There is overall training plan at company wide level and the individual department also
has its own professional training program;
Covers different management levels: middle management, common administrative staff and operators;
Covers different stages: for a new post, at the current post and before transferring to another post;
Throughout multiple ways: to be trained outside the company and to invite external experts to conduct training
as well;
Applies training card system: one card for each employee to record the history of his/her training.

Validation

To establish and perfect the validation system, conduct effective validation and standardizing the validation documents.
Content of validation includes:

Process validation
Cleaning validation
Purified water system validation
HVAC validation (HAVC validation?)
IQ, OQ and PQ of equipment and instrument