B. The engineer has a good idea of the process plans since the pilot plant already prevails.

The aim is
to be able to scale up production to full scale once the drug is approved.

The steps are:

i. Setting of Process design (1 week)

ii. Checking the performance of the prevailing site operation, depending on the operation
results of the existing plant (2-20 weeks)
iii. Improving and selecting the appropriate plan (10-20 weeks)
iv. Comprehensive strategy and materials selection (about 6 months)

For the approval of the new drug:

v. Conducting of experimental trials (6 months up to 2 years)

vi. Assessment of the trial results (usually 3 to 6 months)
vii. Attain the approval of the Food and Drug Authority

Building activities will begin when the preliminary trial results look promising, but the final
construction will only happen when the review of clinical trials is completed.