Course Outcome (COs) B. Pharm-VII Semester

At the end semester, student will able to

BP702 T.1

Define and elaborate Pilot plant, Scale up techniques, SUPAC, Platform Technology. 

BP702 T.2

Summarize WHO guidelines for Technology transfer, protocol, granularity, QRM, Documentation and approved regulatory bodies and agencies.

BP702 T.3

Outline the regulatory affairs and regulatory requirements for drug approval and general consideration on IND, NDA, Investigator’s brochure, FDA  and clinical studies.

BP702 T.4

Explain concept of quality management & certification (TQM, QbD, 6sigma, OOS, NABL, GLP)

BP702 T.5

Extend knowledge on regulatory requirements as CDSCO, State Licensing Authority, COPP and approval procedure for new drug.

CO-PO Matrices of the Industrial Pharmacy I (BP702T)

COs

PO1

PO2

PO3

PO4

PO5

PO6

PO7

PO8

PO9

PO10

PO11

BP702T.1

3

3

3

1

3

3

3

1

1

3

3

BP702T.2

3

3

2

2

3

3

3

2

1

2

3

BP702T.3

3

3

2

2

3

3

3

2

2

3

3

BP702T.4

3

3

3

3

3

3

3

3

3

1

3

BP702T.5

3

3

2

2

3

3

3

1

3

1

3

BP702T

3

3

2

2

3

3

3

2

2

2

3

Average

3

3

3

1

3

3

3

1

1

3

3

 

*Correlation level 1, 2 or 3 is as mentioned below:

  • Slight (Low) = 1;
  • Moderate (medium) = 2;
  • Substantial (high) = 3

                                                                                                                                                                                                                          Mrs. Krishna