Unit test on Unit IV and V

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Name of student

Roll no.

Which department starts the investigation upon receiving Complaints? *

1 point

Production

Quality Control

Quality Assurance

Marketing

When both the complaint sample and retained samples show out of specification result, the complaint is known as_____ *

1 point

Confirmed complaint

Non-confirmed complaint

Coordinated complaint

counterfeit suspicion

Full form of CAPA is_____ *

1 point

Correct activity and prevent activity

Corrective activity and preventive activity

Corrective action and preventive action

None of these

How long the complaint file should be retained after expiry date of the lot *

1 point

2 years

180 days

1 year

5 year

_____defined as removal of the product from market *

1 point

Returned good

Recall

Rejected

None of the above

When the auditor is an employee of the organization being audited (auditee), the audit is classified as an ........ quality audit. *

1 point

internal

external

compliance

Both A & B

Standard Operating Procedure (SOP) refers to: *

1 point

An optimal balance between possibilities realized and a framework of norms and values.

Doing the right thing right, right away, the first time

Detailed, written instructions to achieve uniformity of the performance of a specific function.

A process of meeting the needs and expectations of the customers,both internal and external.

Guidelines for Master Formula record are in_____________ *

1 point

21CFR part 211 section 186

21CFR part 211 section 67

21CFR part 201 section 186

21CFR part 211 section 89

______is prepared by taking reference of Master formula record . *

1 point

Batch manual

Batch Manufacturing record

Batch Production and control record

both B & C

Identify the type of audit in following statement "A customer wants an audit of your company but wants your company to pay for it" *

1 point

Internal Audit

External audit

Regulatory audit

all of the above

Process validation involves a series of activities taking place over the entire lifecycle of the product and process. How many stages of activities have been identified in the FDA lifecycle approach to process validation: *

1 point

one

two

three

four

Identify the type of validation which is conducted for new product. *

1 point

Prospective validation

Concurrent validation

Revalidation

Retrospective validation

I.P.Q.C tests are finalized in _______validation *

1 point

Prospective validation

Concurrent validation

Revalidation

Retrospective validation

______spells out the requirements of cleaning and cleaning validation *

1 point

CFR 211.67

CFR 211.186

CFR 211.81

CFR 211.12

Identify the correct statement *

1 point

Every accurate method is precise

Every precise method is accurate

Every accurate method is not precise

all of them are correct

The amount of sample that can detected but can not be quantified is called as____ *

1 point

Limit of Quantitation

Limit of detection

linearity

range

A measure of method’s capacity to remain unaffected by small but deliberate variations in its parameters is called as_____ *

1 point

Robustness

ruggedness

Precision

Specificity

Identify the correct sequence in equipment validation *

1 point

PQ-IQ-OQ-DQ

OQ-DQ-PQ-IQ

DQ-IQ-OQ-PQ

DQ-IQ-PQ-OQ

In qualification of UV Visible spectrophotometer, wavelength accuracy is checked by using *

1 point

Holmium oxide filter.

1.2% w/v solution of potassium chloride

solution of toluene in hexane

1% solution of NaCl

A document used in production facilities to guide the production of a product is called____ *

1 point

form

batch record

protocols

SOP

Good documentation practices state: Records should be written legibly and be understandable. *

1 point

True

False

Before any batch from the manufacturing process is commercially distributed for use by consumers, the manufacturer should have gained a high degree of assurance in the performance of the manufacturing process based on laboratory, pilots, and commercial scale studies: *

1 point

True

False

Returned goods must be isolated on receipt ,clearly identified & records regarding reason for the return . *

1 point

True

False

Process validation does not helps in reducing batch to batch variation *

1 point

True

False

Store rotation should not be on ―first in ,first out basis. *

1 point

True

False

Define Validation *

1 point

Define Calibration *

1 point

Define SOP *

1 point

Define Audit *

1 point

Define Operational Qualification *

1 point

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