Question and Answers for Pharmaceutical Interview Part 2 

Read Part 1 Here

Who shall be responsible to Coordinates the collection of all data and information required for APQR preparation.......................?

QA Personnel

If any of the batches is failed, then it is not included in the APQR to determine reasons for the batch rejection(TRUE/FALSE)

FALSE

APQR shall be prepared for the drug products (generic name) manufactured in the calendar year from ......................?

A)         January to December

B)         March to April

C)         March to December

D)         None of above

APQR shall be prepared for at least 07 batches manufactured in that year. (TRUE/FALSE)

FALSE

......................trends shall be prepared for critical process parameter and critical quality attributes to easily exhibit the results & deviations.

Graphical 

Who shall generate overall APQR summary?

QA Personnel 

Write full form  of:

A)         Cp: Process Capability 

B)         Cpk: Process Capability Index

If the value of Cpk=1, the process can be considered ...............?

A)         Barely capable

B)         Capable

C)         Less Capable

Question and Answers for Pharmaceutical Interview

Summary of APQR shall not be discussed in management review meeting (TRUE/FALSE)

TRUE

Who shall ensure that failure is reported to QA within specified time?

A)         Head/ Designee- Concerned Department

B)         Head/ Designee- QAD

C)         Head-QAD   

D)         None of Above

Who shall register the Failure Investigation and assign a sequential number to each failure Investigation.

Executive/Designee-QA

Any batch failed to meet the acceptance criteria shall not be evaluated as per Out of specification(TRUE/FALSE)

FALSE

After log in the Failure investigation report, QA shall immediately inform to ..........................regarding batch failure?

Production Head

Investigation shall be initiated within 24 hours and completed within a week to find out reason for failure(TRUE/FALSE)

TRUE

If the batch is rejected, QA shall affix the status label ......................... in red color on whole batch.

REJECTED 

If the batch is rejected after completion of bulk stage and BPR is already issued than same shall be retrieved back from production department(TRUE/FALSE)

TRUE

BPR should be cancelled by striking out the material issue slip page diagonally along with sign and date by ................?

QA Personnel

All documents of rejected batch shall not be kept together with Batch Failure Investigation Report(TRUE/FALSE)

FALSE

Question and Answers for Pharmaceutical Interview

Who shall be responsible for providing the data regarding KPI?

Concerned Department Heads/Designee

Who shall report the KPI’s to the management?

A)         Concerned Department Heads/Designee

B)         Head QA/Designee

C)         Both of Above

Key performance indicators (KPI) are a set of quantifiable measures used to gauge performance over time? (TRUE/FALSE)

TRUE

KPI for both RM/PM on supplier product quality shall be collected by ……………..?

A)         QA 

B)         QC

C)         Warehouse

None of Above 

In case the KPI figures are higher than the acceptance criteria, necessary corrective/ Preventive actions shall be taken? (TRUE/FALSE)

TRUE

Define RFT………………………….?

RIGHT FIRST TIME

The Target of KPI for RFT is 10 %? (TRUE/FALSE)

FALSE

Batch recall should not be more than ……………………?

A)         0%

B)         2.5%

C)         5%D)    1%

The internal, external and regulatory audit compliance should be within timeline? (TRUE/FALSE)

TRUE

The target of KPI for overdue to compliance of non-conformance NMT ……………….?

 5%

Who shall be responsible to Prepare, arrange, checking and revision of layouts?

A)         Executive QA/Designee

B)         Head Engineering/Designee

C)         Head EHS/Designee

D)         None of above

Who shall ensure the emergency evacuation in layout (if required)

Head EHS/Designee

Who shall Approve the Layouts?

Head-QA/ Designee  

All Layout shall be prepared by external agency/Engineering as per the requirement and input provided by the Engineering Team of Pontika Aerotech Limited(TRUE/FALSE)

TRUE

The external agency/Engineering shall provide the three copy of layouts (TRUE/FALSE)

FALSE

All the layout shall be finally checked by engineering department and reviewed by ..........................?

A)         Plant Manager

B)         Head EHS/Designee

C)         Head Engineering/Designee

D)         None of above

The QA shall place the ..................stamp on layout.

Question and Answers for Pharmaceutical Interview

Approved

All approved layout shall be maintained by ......................Department?

A)         QA

B)         Engineering

C)         EHS

D)         None of Above

If any changes to be done in facility on layout revision shall be done through change control(TRUE/FALSE)

(TRUE)

Who shall intimate and offer the finish good to IPQA Person for terminal Inspection?

Officer/Executive-Production

Who shall perform the terminal inspection.

A)         Officer/Executive-Production

B)         IPQA-Personnel

C)         Head-QA /Designee                         

Terminal inspection is the process for checking of defects in finished good prior to dispatch to market (TRUE/FALSE)

TRUE

IPQA Personnel shall select randomly ...........of the total number of finished good?

√n+1

First shipper and last shipper must be inspected for all defects but not including Loose Shipper (TRUE/FALSE)

FALSE

The Production Personnel Shall Record the defects/Correctness observed on the above parameters in Terminal Inspection (TRUE/FALSE)

FALSE

Who shall check the product particulars to be inspected as offered by the 

packing in charge.

The IPQA person

The defect can be categorized as.......................... 

1)         Minor 

2)         Major 

3)         Critical

If any critical defect observed, then 100% batch shall be checked (TRUE/FALSE)

TRUE

If any customer provides his Terminal inspection/ AQL format inspection shall not be performed as per customer checklist (TRUE/FALSE)

FALSE

Who shall be responsible for Maintaining records of NCR......................?

A)         QA-Personnel

B)         Concerned Personnel

C)         Both of Above

Any non-conformance observed shall be recorded in ‘Non-conformance Report’? (TRUE/FALSE)

TRUE

Who shall issue the format of NCR to concern department/personnel after allocating NCR number and making entry in register?

QAD

The non-compliance observation shall be classified into critical, major and minor category? (TRUE/FALSE)

TRUE

Who shall investigate the root cause of non–conformance?

A)         QA Head/Designee

B)         Concerned department Head

C)         Both of Above

if in process product or finished product is non-conforming, then it should be quarantined with .................... and shifted to designated area in supervision of QA personnel?

HOLD

Non Conformance Report shall be approved by ........................?

HEAD QAD

NCR shall be closed within .............. working days?

A)         05

B)         07

C)         10

D)         15

A photocopy of product related NCR shall be attached with concerned records? (TRUE/FALSE)

TRUE

Who shall ensure that an OOT records is initiated, upon basics of OOT results?

A)         QA Personnel

B)         QC-Personnel  

C)         Head-QA

D)         Head-QC

Trending is a graphical illustration of data on how a process or product parameters behaves over time (TRUE/FALSE)

TRUE

In case of stability samples, if assay results obtained beyond ..............of the result of its initial value then it shall be considered as OOT result?

A)         ± 5%

B)         ± 7%

C)         ± 10%

D)         None of above

If error is due to spilling of sample solution or incomplete transfer of sample, analyst should not document what had happened(TRUE/FALSE) 

FALSE