Quality Control and Plant Location

present by Waraporn Parnlob

Quality Control

I

Introduction in Quality Control

I

Effect of manufacturing process on Quality

I

Raw material control

I

Labeling and packaging material control

Quality Control (cont.)

I

In -process and Production Control

I

The Use of Statistical Quality Control

I

Conclusion

What is the Quality control?

“ An aggregate of activities designed to ensure adequate quality in manufactured products”

Effect of manufacturing process on Quality Major Aspect

• • Engineering and maintenance The process

The Five Type

a Raw materials a Labels a a a Packaging material In process Finishing product

They are termed variable because minor variations in anyone of these areas affects the other areas.

Raw material Control

Raw material

“

the solvents and chemical, whether active ingredient or inactive excipient, used in the manufacture of the dosage form.”

Raw material Control (Cont.)

Raw materials, whether solids, liquids, or gases, all must be purified for use in drug products.

Quality concern involve testing and inspection of - incoming solid - holding and distribution systems for liquids - distribution system for gas

The quality of the raw material is always defined by certain specification, with tests required to determine its identity, assay, quality,and purity using physical, chemical and microbiology procedures.

Labeling and Packaging material Control Labeling “ a display of written printed or graphic matter accompanying the product ” Packaging Material “ anything used in packaging a product ”

Labeling and Packaging control

q Control by sampling and testing and use the statistical method in evaluation.

q Maintenance and storage of each of the label and package.

In-process and production control

In-process include premixes, granulations, bulk tablets or capsule. Also include in this classification are packaged products that require additional processing.

In-process and production control

Production and control procedures should include all reasonable precautions to assume that the product has the safety, identity, strength , quality and purity.

The use of statistical quality control

To increase productivity through total control of quality ; Control Chart assist in achieving this purpose.

Control Chart

“ A graphical representation of variation that affect the quality of product.”

Control Chart use

X Prediction of product quality trends X Provides a sound bases for establishing or change manufacturing specification X Improving, narrow or otherwise change minimum or maximum property limit

Upper control limit(max) Normal (average) Lower control limit (minimum)

Upper control limit = p + 3 (p(100-p)/n) 1/2 Lower control limit = p - 3 (p(100-p)/n) 1/2 n = sample size p = average percent defection across many sample

Conclusion input output materials and supplies Production Process conversion Product Control chart

Conclusion

l Quality control must use through out production system.

l Developing control chart programs to monitor the process that meet customer expectation that is the basic for determining if product are of superior quality

Plant Location X Thailand X General Information of Factors Affecting Location X Conclusion

General Information

2 2 Topography 2 Climate 2 Population

Geography

1 Situated in the heart of the Southeast asia mainland 1 Long coastline on the Gulf of Thailand and the Indian ocean

Topography

Thailand is divided into 4 natural regions.

3 The North 3 The Central Plain 3 3 The Northeast

Climate

ท Thailand is warm and rather humid tropical country. ท The average temperature is 28.1

Population

ม the population reached 62.1 million in ม The size of the work force exceed under 32 majority of the workforce 30 .9 million,with the years of age.

used to continue to increase into 21

Population

Minimum wage in Thailand

Factor Affecting Location

4 Infrastructure 4 4 n Labors Issues

Infrastructure

ท Water supply ท Highways ท Electricity ท Seaports ท Railways ท Telephone services ท Airports

Taxati on

J J J J Corporate Income Tax Excite Tax Value Added Taxes Import Tariffs

Labors Issues

Wage Rate M Overtime Regulation

Industrial Estates a Have Infrastructure that investigator want a Privilege in Taxation a Have labor enough to work in plant.

Industrial estate have in privilege . 3 zones ,different

Conclusion

The suitable plant location of production group is in the third zone of Industrial estate and for comfortable communication will select Lam Cha Bung Industrial estate.