MCQ on MBA Pharma Management
Pharmaceutical Quality Assurance
1.
The personnel related legal aspects are covered
in regulatory literature, only by MCC South Africa guidelines, WHO and
……………………………….
Ans: 1. Schedule A of India 2. Schedule M of D and C Act of India 3.
Schedule M of N and C Act of India
2.
The manufacturing shall be conducted under the
direct supervision of competent technical staff with prescribed qualifications
and practical experience in the relevant dosage form and or/ active
pharmaceutical products. This is mentioned under which schedule of ……………D and C
Act India.
Ans: 1. Schedule M of D and C Act
of India 2. . Schedule M of N and C Act of India 3. Schedule 4 of Pharmaceutical act
3.
The testing shall be conducted under direct
supervision of ……………………, who shall be whole time employees of the licensee.
Ans: 1. Quality head 2.
Production head 3. Quality supervisor 4. Competent technical staff
4.
According to WHO guidelines what do national
legislations describe?
a.
The national legislation explains the key
responsible for supervising the manufacture and quality control of
pharmaceutical products should possess the qualifications of scientific
education and practical experience.
b.
The national legislation explains the key
responsible for the position of quality control manager of pharmaceutical
products should possess the qualifications of B.Pharma and practical
experience.
c.
The national legislation explains the key
responsibility of QC and Production head.
5.
The quality of medicine depends upon the quality
of ……………………………….who produce them.
Ans : 1. People 2. Raw materials 3. Process
4. Quality management
6.
The regulatory guidelines on personnel matters
explain various matters, which among them is not one of them?
a.
People must be qualified, experienced and trained.
b.
Must be sufficient in number
c.
Job responsibilities need not to be explained
and motivated
d.
Must follow hygienic practices
7.
The establishment and maintenance of a
satisfactory system of quality assurance and the correct manufacture and
control of pharmaceutical products and active ingredients rely upon people.
This is explained by which guidelines:
Ans: 1. WHO guidelines on
GMP 2. GMP guidelines of medicine
production 3. WHO guidelines on quality
assurance
8.
WHO
guidelines on GMP gives some guidelines on the qualifications e.g it states
that the education should include study of an appropriate combination of
various subjects, which of the following
is not one among them:
1.
Chemistry
2. Chemical engineering 3.
Pharmacology 4. Physiotherpalogy
9.
Is PG Diploma in packaging technology relevant
for a Pharma production personnel…………………..(T/ F)
10.
For a QA/ QC what is the requisite
qualifications:
a.
M. Pharma
b. M.Sc and Phd c. Phd in
analytical chemistry d. Any one of them
11.
Is knowing of GMP important for considering a
trained personnel ………………….T / F
12.
The sufficiency is to be defined based on the
………………………in various geographical areas and diversified work areas to be carried
on.
a.
Work unit
b. Work load c. No of staff d. Supervisory responsibilities.
13.
What does TGA Australian guidelines explains
about sufficiency:
a.
The sufficient number of staff should be there
in production.
b.
The responsibilities placed on any one
individual should not be so extensive as to present any risk to quality.
c.
The responsibilities placed on any one
individual should be according to his qualifications and experience.
d.
The responsibilities should be distributed well.
14.
A job description must contain the following
except:
a.
Organizational position, authority,
responsibility, relationship.
b.
Individual assignment
c.
Job summary
d.
Job specification
15.
According to WHO the few regulatory guidelines
have been mentioned here, which among them is not prescribed as per WHO?
a.
Head of production
b.
Head of QC
c.
Head of QA
d.
Head of sales and distribution
16.
The two important profiles are Head of
production and Head of QC. Few of important job descriptions of Head of QC are
mentioned here, which among them is wrong?
a.
Approval or rejection of in process and finished
products
b.
Evaluation of batch
c.
Adherence to statutory guidelines regarding
appointment of personnel and statistical analysis and interpretation of
marketing and sales data.
d.
Ensure that the appropriate validations,
including those of analytical procedures and calliberations of cobtrol
equipment are done.
17.
As per personnel requirements in the pharmacy
manufacturing the guidelines stats that people engaged should be experienced,
trained, qualified and should be healthy with good hygienic and sanitation
habits. The high standards of personnel cleanliness should be observed by all
those concerned with production processes. Additional specific and stringent
requirements must be kept in mind for people employed in ………………………………………
a.
Sterile – products manufacturing b. All employees c. Quality assurance team
18.
Visual inspection staff should pass an annual
…………………………….examination.
a.
Eye examination
b. Quality examination c. Six
sigma d. Statutory guidelines
19.
How can direct contact between operators
influence the product quality…………………………
a.
Contamination
b. Adversely affect the quality
c. Neutral d. Cleanliness
20.
As per USFDA who is a consultant?
Ans:
Best of luck!
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