Scribd
Upload
170 views27 pages

QA MCQs Unit 3

Uploaded by

himanshukurrey951
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
170 views27 pages

QA MCQs Unit 3

Uploaded by

himanshukurrey951
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 27

25 Important MCQs

Unit –III
(With Solutions)
Pharmaceutical Quality Assurance
BP 606T
By
Dr. Mahendra Pratap Singh
Assoc. Prof. & Vice Principal
Krishnarpit Institute of Pharmacy
Prayagraj, India
Question.1:- Type II glass is called as-
a) General soda lime glass
b) NP glass
c) BS glass
d) Treated Soda lime glass
Answer: d) Treated Soda lime glass
Explanation:-
Type I - Borosilicate Glass (also known as Pyrex)
Type II - Treated Soda-Lime Glass.
Type III - Soda-Lime Glass or Soda-Lime-Silica Glass
Type IV -General-purpose soda lime glass(Type NP glass)
Question.2:- What is tamper evident package
a) Indicate the evidence of opening of package
b) Opened package
c) Unsealed package
d) Envelop or pouch

Answer: a) Indicate the evidence of opening of package


Explanation:- According to the U.S. Food and Drug
Administration, “A tamper-evident package is one having one or
more indicators or barriers to entry which, if breached or missing,
can reasonably be expected to provide visible evidence to
consumers that tampering has occurred
Question.3:- Thermoplastics are
a) Gets softened on heating
b) can be molded
c) does not degraded by repeated heating
d) all of the above

Answer: d) all of the above


Explanation:- Thermoplastics are defined as
polymers that can be melted and recast almost
indefinitely. They are molten when heated and
harden upon cooling
Question.4:- The package that comes in contact with
formulation directly is called-
a) Primary package
b) Secondary package
c) Primary and Secondary package
d) Tertiary package
Answer: a) Primary package
Secondary packaging is used for the branding and
display of the product
Tertiary packaging is used for the protection and
shipping of a product
Question.5:- Following is not a primary packaging.
a) Ampoule
b) Bottle
c) Cartoon
d) Strip packaging.

Answer: c) Cartoon
Question.6:- Edge protection is required in-
a) Primary pack
b) Secondary pack
c) Tertiary pack
d) None of these

Answer: c) Tertiary pack


Question.7:- The yellow colour glass is manufactured
by adding
a) Feric oxide
b) Cupric oxide
c) Cadmium Sulfide
d) cobalt

Answer: c) Cadmium Sulfide


Question.8:- Number ‘6’ on plastic containers refers
that it is manufactured using-
a) Polyethylene
b) Polystyrene
c) Polyvinyl
d) polypropylene
Answer: b) Polystyrene (PS)
1: PET or PETE (Polyethylene terephthalate)
2: HDPE (High density polyethylene)
3: PVC (Polyvinyl chloride)
4: LDPE (Low density polyethylene)
5: PP (Polypropylene)
Question.9:- Water attack test is used to identify the
alkalinity in-
a) Type-I glass
b) Type-II glass
c) Type-III glass
d) Umber coloured glass

Answer: b) Type-II glass


Question.10:- As per ICH Stability Zone India
falls under which stability zone-
a) Zone I Temperate Zone
b) Zone II Mediterranean/Subtropical Zone
c) Zone III Hot Dry Zone
d) Zone IV a Hot Humid/Tropical Zone & Zone IVb Hot
/Higher humidity

Answer: d) Zone IV a Hot Humid/Tropical Zone


& Zone IVb Hot /Higher humidity
Question.11:- Light transmission test for glass is
measured at spectral region of
a) 290nm to 450nm
b) more than 500 nm
c) 500nm- 900 nm
d) None

Answer: a) 290nm to 450nm


Question 12:- Annealing is a process of-
a) Cooling
b) Heating
c) Melting
d) Titrating

Answer: a) Cooling
“Annealing” is controlled process for cooling glass to
relieve interior stresses.
Question 13:- Which is/are important
chemical test for glass containers-
a) Hydrolytic resistant test
b) Water attach test
c) Arsenic test
d) All of them

Answer: d) All of them


Question 14:- Which is/are important QC test for
Collapsible tubes-
a) Leakage test
b) Power of adhesion
c) Flexibility test
d) All

Answer: d) All
Question 15:- The classes of studies that are included
in GLP are-
a) Single dose toxicity
b) Repeated dose toxicity
c) Both a and b
d) None of the above

Answer: c) Both a and b


Question.16:- Under Good Laboratory practice
which of the following are regulated-

a) Planned, performed,
b) Monitored, recorded
c) Archived and reported.
d) All of the above

Answer: d) All of the above


Question 17 :- Which of the following studies are not
included in GLP-
a) Reproductive toxicity
b) Mutagenic potential
c) Carcinogenic potential
d) Toxicokinetics
e) None of the above

Answer: e) None of the above


Question 18:- In order to ensure good operational
management GLP principles require institutions to-
a) Assign roles and responsibilities to staff
b) Provided adequate physical facilities and qualified staff
c) Provide facilities should be of suitable size,
construction and location
d) All of the above

Answer: d) All of the above


Question 19:- If a testing facility has been disqualified, any
studies were done before of after the disqualification will
need to be determined as essential to a decision-

a) True
b) False

Answer: a) True
Question 20 :- Who has the overall responsibility for
the scientific conduct of a study and can confirm the
compliance of the study with the Principles of Good
Laboratory Practice
a) Study director
b) Analyst
c) Principal investigator
d) None of the above

Answer: a) Study director


Question 21 :- Which CFR Deals With Good Laboratory
Practice for Nonclinical Laboratory Studies-

a) 21 CFR 50
b) 21 CFR 56
c) 21 CFR 58
d) None

Answer: c) 21 CFR 58 (June 1979)


Question 22 :- Consequences of Noncompliance can be

a) Final order of noncompliance will be sent to the facility


with explanations.
b) The facility may not receive or be considered for a
research or marketing permit and the study is rejected.
c) Both a and b
d) None of the above

Answer: c) Both a and b


Question 23 :- The study plan should be approved
by-

a) Study Director
b) Quality Assurance personnel
c) Principal investigator
d) Contract analyst

Answer: a) Study Director


Question 24 :- For test and control items the
following information is not mentioned on label-

a) Distribution record
b) Test item name and Batch number.
c) Expiry date and Storage conditions.
d) Container number and Tare weight.
e) Initial gross weight.

Answer: a) Distribution record


Question 25 :- Corrections or additions to a final
report shall be in the form of __________by the
study director-
a) Amendment
b) Orally
c) Raw data
d) None of the above

Answer: a) Amendment

You might also like