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Taipu Pharmaceutical

      Tianjin Taipu Pharmaceutical Co., Ltd. (TP), wholly owned by Tianjin Taipu Pharmaceutical Technology Development Co. Ltd., was founded in December 2010 and focuses on API producing.

      With the pursuit of efficiency and high-grade APIs, TP put the R&D results of its parent company and the Tianjin Institute of pharmaceutical research into clinical research and production.

1. Multiple departments with clear duties are set up, responsible for its leaders respectively.

2. Regulations on duties and work standards of various departments are laid down. Management and techniques personnel have adequate experience and knowledge in pharmaceutical as well as qualifications for their responsibilities. 

Organizational chart

The general manager is in charge of the company.

Quality controller, in charge of the QC and the new products departments; 

Deputy General Production manager, in charge of the production and the integrated management department

General Manager, in charge of 7 departments, including human resources department, finance and sales departments.

The QC performs its duties independently.

Among the existent 69 staff, 6 are of graduate degree; 56, of university and college degree; 12, senior titles; 8, intermediate titles; 3, junior titles. 

Senior technical staff accounts for 17.4%; middle, 11.6%; and junior, 4.3%. 

In accordance with GMP, all its management and techniques personnel have adequate pharmaceutical knowledge and previous relevant experience.

Key personnel are full-time, and quality manager and production manager are separate from each other.

General training program and regulations of training management are made up. The training content covers company profile, laws and regulations, quality and safety knowledge, management systems and SOP. Personnel from different departments are trained in teams with different contents and purposes. The Qualified during the training are eligible to work and evaluation for training results will be conducted regularly. 

TP is located in the West of Tianjin Economic-Technological Development Area (TEDA). Its location, design, layout and construction are in line with the requirements of pharmaceutical manufacturing, thus pollution and cross contamination avoided to the maximum. 

Clean manufacturing environment, tidy and flat ground for transport, reasonable layout and orderly streams of people and goods assure the safety of products. 

1 office area, production area and living area are separate from each other. The workshop is designed in accordance with GMP. There is no polluting source for products. Complete infrastructure assures adequate energy supply.

2 The API workshop has a construction area of 13229m2, with 5 synthesis production lines and 2production lines in clean areas.

3 There are 4 separate warehouses for finished goods, raw materials, packing materials and dangerous goods in the north of the clean workshop.

4 Power plant and sewage disposal plant is in the northwest of the plant.

TP has advanced API manufacturing equipments and supporting facilities and has conducted their verification, which can meet the production of the declaration products.

Equipment maintenance schedule and plan are made, and the records are kept. Operating and cleaning procedures for manufacturing equipments are set up with obvious status indication.

The air conditioning unit is automatic. The air is disposed through primary, medium and high efficiency filters under the air purification system, ensuring the constant temperature, humidity and ventilation in clean areas. 

Water purification system runs under the PLC program either automatically or through touching screen and hand operate valve, convenient for adjusting and maintenance. 

The drinking water is purified through pretreatment system, two-pass reverse osmosis and EDI processing systems. Purified water produced constantly and distributed assures water supply for manufacturing process.

The utility system provides adequate energy for manufacturing.

Materials and storage

Management and handling process rules are set for the purchasing, storage, releasing and using of materials. Suppliers of raw materials and excipients and their QA systems are inspected. Suppliers lists are filed.  QC will test the incoming raw materials and excipients before they are used. 

Materials are placed according to their kinds with obvious labels indicating for-testing, qualified and unqualified status. 

Warehouses are divided for non-compliances goods and rejected goods. Temperature and humidity are tested in it and then recorded.

Materials and products with obvious labels are stored under required temperature in batches.

Sampling labels are with the sampled raw materials and packaging materials, while qualified labels are with qualified materials. 

Re-testing system is made, under which raw materials and packaging materials are re-tested regularly.

QC laboratory is well-equipped with testing facilities, capable for independent physical and chemical tests as well as micro-biological tests. 

Procedures are made for using and maintaining such testing facilities which are under special management. Precise instruments and weighing apparatuses are calibrated regularly. 

Quality standards, sampling and testing procedures for materials, semi-finished products and finished products are set up, under which materials and products are tested in batches and reports are made accordingly.

Quality management system is made in accordance with the requirements of drug quality management. The quality system is applied fully through the whole process from pharmaceutical manufacturing, its quality control to release, storage and transport. Thus declared drugs produced meet the intended use and quality requirements

A sound filing system covering all factors affecting product quality is developed.

The system includes the documents of quality control, production management, materials and products management, workshop and facility management, equipment management validation and confirmation management as well as personnel and department management. 

Quality management involves risk management, deviation handling, change control, corrective and preventive actions, product quality review, supplier evaluation and approval, the material and product release audit, complaints handling, inner-inspection, recall and return etc..

QA system assure:

1. Constant with 2010 edition of GMP;

2. Clear management responsibilities;

3. Correct raw materials and packaging materials;

4. Effective control of intermediate products;

5. Planned the confirmation and verification;

6. Strict procedures of production, inspection, validation and review;

7. Product release with the approval of the quality authorizer;

8. Ensure product quality in storage and delivery process;

9. Regular inner-inspection to assure the effectiveness and applicability of the QA system. 

As a pharmaceutical manufacturer, ensuring quality and safety of products is our first priority and eternal pursuit. 

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