Pharmaceutical Interview Questions 2
11)What is the Technology Transfer?
In the pharmaceutical industry, “Technology transfer” refers to the
processes that are needed for successful progress from drug discovery to
product development to clinical trials to full scale commercialization or it is
the process by which a developer of technology available to commercial
partner that will exploit the technology.
To assure the drug quality, it is desire to make sure 5 W’s & 1 H, that is
what 1, when 2 & why 3 information should be transferred to where 4 & by
whom 5 & how to transfer, then share knowledge & information of the
technology transfer each other between stake holders related to drug
manufacturing.
12)What is the name of different countries of GMP guidelines for
manufacturing of API?
WHO GMP- Geneva
ICH Q7A- Europe, Japan & US
EU GMP- Europe
MCC- South Africa
APIC GMP- Active pharmaceutical Ingredient Committee (A sector
group of CEFIC)
USFDA GMP- United States of America
PIC/S GMP- Germany
Schedule M- Indian
13)What is preventive maintenance?
It is periodic inspection & minor repairs of equipment as per schedule
given in the SOP. This enables smooth operation & long life of the
equipment. It also avoids major breakdown of the equipment during
manufacturing of the product.
There are two types of maintenance.
a) Preventive maintenance: Schedule maintenance before any break
down of machinery which prevents the machine break down.
b) Breakdown maintenance: Maintenance was done after stopping
machine breakdown. Weekly, Monthly, Quarterly, half year & yearly
preventive maintenance.
14)What do you mean by “Quality Assurance”?
The sum total of the organized arrangements made with the objects
of ensuring that all APIs are of the quality required for their intended
use & the quality systems are maintained.
15)What are the types of different training programs?
a) Induction training
b) Job oriented training
c) cGMP training
d) On-going training
16)What is cGMP?
Current Good Manufacturing Practices.
This mean any procedure/ system adopted by the manufacturer
which proves to be necessary & important for identify, strength &
purity of a product.
17)What are the requirements for the equipment used in the
manufacturing of process of API?
Material of construction used for equipment should not
React with component
Get corroded, cause rusting
Impart any impurities, absorb
Should be of appropriate design, adequate size & have smooth
surface.
18)How are cGMP implemented?
Training, compliance to SOPs, control on operations, following
procedures/system, monitoring through compliance audits.
19)What is solvent? What is the classification of residual solvents?
An organic or inorganic liquid used as a vehicle for the preparation of
solutions or suspensions in the manufacturing of an intermediate/
API.
Residual solvents are classified into three class based on the possible
risk to human health.
Class-I (Solvents to avoided)
Class-II (Solvents to be limited)
Class-III (Solvents with low toxic potential)
20)What is the diff. between Responsibility & Accountability?
Responsibility: Personnel directly associated with the implementation of
the procedure
Accountability: Person directly associated with the implementation of
the system under which the procedure falls.
