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Wednesday, September 3, 2008

Sterile Production Training Questions and Answers

Section – Sterile Production

In this post i am giving some questions of which you may know answers or you may like to know answers ,i have given few options for you to think up on , this is a very good tool to gather knowledge these questions are provided with answers at the bottom of every page ,so enjoy solving them, you can use these questions and answer sheet to train your personnel.
1. The GMP requirements for sterile production are:

A) exactly the same as for all other types of production

B) completely different from all other types of production.

C)a combination of normal GMP requirements plus some additions.

D)different for large companies and small ones.

2. The main contamination risk to sterile products comes from:

A) Pyrogens

B) microorganisms

C) particulates.

D)all of the above.

3. Terminally sterilized products are:

A) those that are sensitive to heat and gamma irradiation.

B)those that can be sterilized after filling and sealing.

C)those products that can be autoclaved.

D)usually suspensions or powders.

4. Sterile filtered products are:

A)those that are sensitive to the terminal sterilization process.

B) those that can be sterilized after filling and sealing

C) those products that can be autoclaved.

D)usually suspensions or powders.

5. The choice of sterilisation method is dependent on:

A)The procedure of preparation of the components.

B)Automated filling and sealing.

C)The temperature in the area

D)The properties of the materials and product.

6. The personnel working in a sterile production area should:

Section – Sterile Production

Test Answers

1 C

2 D

3 B and C

4 A

5 D

6 B

I hope you enjoy reading this training tool on WHO GMP for pharmaceutical manufacturing .

Email this to your colleague friend or who is working with pharmaceutical manufacturing firm
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials


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