Pharmaceutical industry GMP #7

 

According to the text, which answer is not correct ?

1.Why is product sampling carried out ?

    a. To introduce produce product quality

2. Which aspect of drug manufacturing enables traceability?

    c. Holistic approach

3. Why do operational method and procedures have to be validated ?

    d. To isolate product of high quality

 

Complete the following sentences with the correct word or expression in bold the text in exercise 1.

1. The documentation required for all research prosses and development steps ensures the processes, activities, and operations involved of a drug.

2. A holistic approach looks at all these environments to make sure that the entire process meet high        industry standards considers laboratory and manufacturing processes and environments together and not individually.

3. Quality control ensures involves all manufacturing processes GMP wich make sure the goods produced are kept at high standards.

4. Quality of pharmaceutical product involves interim and product sampling procedures, which are carrued out to check product quality.

5. At the end of every stage of product`s manufacturing process, endpoint testing is done to maintain quality standards.

6. Even a product that has been marketed for years might have to be taken off the market in a complete product recall if serious adverse reactions occur.

7. Manufacturing processes and procedures must go through periodic in the pharmaceutical industry, different quality assurance processes are required foreach area of good practice (GxP).

8. Documentation is importan and necessary at every step of the proscesses, activities, and operation involved in drug manufacturing.if the documentation is not in order, or if the required specification are not met, then product is considered product are no longer pure and acceptable for sale or public used and, therefore, must be returned to the manufacturer, or destroyed.

Best regards,

Sri ayu lestari