Theory Continuous Exam (CA- I)

Roll No.

Name of Student

Q.1 Which of the following is not a scale-up process?

• a. Laboratory to pilot-scale
• b. Pilot-scale to industrial-scale
• c. Industrial to pilot-scale
• d. Laboratory to industrial-scale

Q.2 Which one of the reasons does not justify granulating

• a. To impart good flow properties to the material
• b. To increase the apparent density of the powders
• c. To decrease the particle size
• d. To make uniform dispersion of active ingredients

Q 3. Weight variation in capsules may come due to

• a. improper lubrication
• b. poor flow characteristics
• c. plug sticking to the dosator
• d. All of the above

Q.4 Which one of the parameters should not be consider during choosing the size and type of pump for scaling up semisolid dosage form

• a. Pumping rate
• b. Mixing speed
• c. Product viscosity
• d. Pumping pressure

Q. 5 Select the responsibility/s of RA personnel

• a. To analyze the content of the active ingredient in the formulation
• b. Work with federal, state and local governing agencies to get the approval for drug
• c. To undertake stability studies of the drug products
• d. To supervise the production of the formulation

Q. 6 The headquarter of CDSCO is located at

• a. New Delhi
• b. Kolkata
• c. Mumbai
• d. Chennai

Q. 7 Which one of the following is not a part of space requirement in general consideration for pilot plant

• a. Physical testing area
• b. Equipment floor space
• c. Storage area
• d. Raw material

Q.8 Identify the relevant regulatory body in USFDA for approval of drugs.

• a. BLA
• b. IND
• c. CBER
• d. CDER