Contrôle De Qualité II Test

0 votes, 0 avg

You will have 60 minutes to complete all the questions. After the timer reaches 60 minutes, the exam will end and be saved automatically. Good luck! *Fingers crossed*

The timer has been reached. The exam has now been terminated and saved.

1 / 60

What is the primary purpose of conducting a validation study in the pharmaceutical industry?

a. To establish documented evidence that a process consistently product meeting its predetermined specifications

b. To determine the optimal production capacity

c. To assess the market demand for a product

d. To confirm the accuracy of financial forecasts

2 / 60

Choose the correct sentence?

a. Production department is depending on QA operating procedure.

b. Quality control is depending on production and quality assurance department.

c. SOP has instructions on how to write a formal operating procedure for your systems which your people can follow everyday.

d. QC is responsible of approval SOP.

3 / 60

Choose the correct sentence?

a. Only quality assurance can report of deviation

b. Any department in pharmaceutical system can write deviation report after problem happened.

c. Production will write deviation report after raw materials are mixed.

d. deviation is reported by QC after every batch analysis

4 / 60

Quality Assurance involved in pharmaceutical manufacturing process from?

a. Purchase of starting materials to batch release for sale

b. Purchase of starting materials to sampling for quality control of finished product

c. Sampling for quality control of starting materials to quality control of finished product

d. Sampling of starting materials to batch release for sale

5 / 60

Which phrase is not correct about deviation report system?

a. It is a regulatory requirement to capture all sorts of deviations to maintain the continuous improvement to your processes and systems

b. It describes the management responsibilities of initiating deviation and initiatives to be taken on corrective and preventative actions.

c. Before the deviation is reported, the corrective and preventative actions have to be completed.

d. It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes.

6 / 60

Product may cause temporary or remote adverse health issues after receipt of complaint must be recall within?

a. 7 working days

b. No limit timeframe

c. 3 working days

d. 5 working days

7 / 60

The procedures of quality control laboratory are included, except?

a. Management of reference substances

b. Retest dating of raw materials

c. Deviation reporting approval

d. Calibration policies for laboratory instruments

8 / 60

A complete record of all raw data generated during each test, in addition to graphs, charts, and spectra from laboratory instrumentation, all properly identified to show the specific material and the batch tested is?

a. Laboratory control records

b. Validation protocols and reports

c. Certificate of Analysis

d. Manufacturing and packaging instructions

9 / 60

The procedures of quality control laboratory are included, except?

a. Retention samples laboratory

b. Self-inspection

c. Stability study protocols

d. Laboratory result out of specification report

10 / 60

The main objective of quality assurance is?

a. Quality conformance

b. Inspection of quality of product

c. Proof of fitness of product

d. Customer satisfaction

11 / 60

What does the abbreviation GMP stand for in the context of quality assurance in the pharmaceutical industry?

a. Generic manufacturing procedures

b. General manufacturing principles

c. Good manufacturing practices

d. Global manufacturing protocols

12 / 60

Which of following is a key principle of quality assurance in the pharmaceutical industry?

a. Increase production speed

b. Maximize shareholder value

c. Reduce employee turnover

d. Continuous improvement

13 / 60

Which phase of process validation involves demonstrating that a process can consistently produce a desired product under normal operating conditions?

a. Process design qualification (PDQ)

b. Performance qualification (PQ)

c. Installation qualification (IQ)

d. Operation qualification (OQ)

14 / 60

The sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use is the principle of?

a. Production

b. Purchase

c. QC

d. QA

15 / 60

Quality Control involved in pharmaceutical manufacturing process from?

a. Sampling for quality control of starting materials to quality control of finished product

b. Purchase of starting materials to batch release for sale

c. Purchase of starting materials to sampling for quality control of finished product

d. Sampling of starting materials to batch release for sale

16 / 60

When there is probability that Product may cause temporary or remote Adverse health issues it is?

a. Class II recall

b. Class I recall

c. Class IV recall

d. Class III recall

17 / 60

Withdrawing or removing the product from distribution network as of quality issues/ adverse drug reactions is known as?

a. Restoring of goods

b. Returning of goods

c. Reporting of goods

d. Recalling of goods

18 / 60

Which type of validation is conducted when changes are made to an existing validation process or equipment?

a. Cleaning validation

b. Analytical method validation

c. Process validation

d. Change control validation

19 / 60

Which following is not a component of quality assurance in a pharmaceutical plant?

a. Quality control

b. Quality management

c. Quality improvement

d. Quality assessment

20 / 60

Serious adverse reactions of product that cause serious consequences to health after receipt of complaint must be recall within?

a. 5 working days

b. 3 working days

c. No limit timeframe

d. 7 working days

21 / 60

What is the reason for initiating a CAPA?

a. To deviate from a Work Instruction

b. To rework a product

c. To make a risk assessment

d. To eliminate a nonconformity

22 / 60

An enclosed space with two or more doors, which is interposed between two or more rooms for the purpose of controlling the airflow between those rooms when they need to be entered, is?

a. Production line

b. Quarantine zone

c. Clean area

d. Airlock

23 / 60

Which of the following options is correct regarding Production and QC?

a. Production is an integral part of QC

b. QC is an integral part of Production

c. QC may or may not depend on Production

d. Production and QC are independent to each other

24 / 60

Issues related to foreign matter in a product is?

a. Physical properties complaint

b. Product complaint

c. Service complaint

d. Packaging complaint

25 / 60

Which QMS tool is used to track and analyze customer complaints and feedback?

a. Check sheet

b. Control chart

c. Complaint trend analysis

d. Scatter diagram

26 / 60

The entry in Batch Manufacturing Record is done by?

a. Quality assurance department

b. Production department

c. Quality control department

d. Warehouse department

27 / 60

What is the role of standard operating procedures (SOPs) in quality assurance?

a. To define employee work schedules

b. To outline manufacturing processes

c. To calculate financial ratios

d. To quality control limits

28 / 60

Bulk/ finished product when retrieval or withdrawal from market is known as?

a. Recalled goods

b. Received goods

c. Returned goods

d. Expired goods

29 / 60

The assay depends on the inhibition of growth of a microorganism in a uniform solution of the antibiotic in a fluid medium is the principle of?

a. Spectrophotometry and Chromatographie (HPLC)

b. Titration and Identification

c. The cylinder-plate (or plate) assay

d. The turbidimetric (or tube) assay

30 / 60

Which of the following is an example of an analytical testing method used in quality assurance of pharmaceutical products?

a. High-performance liquid chromatography (HPLC)

b. Inventory management

c. Production scheduling

d. Statistical process control

31 / 60

The following statements are true, except?

a. All complaints must be reviewed according to written procedures

b. Recall operations must be able to be initiated promptly at any time

c. Recall Operations can only be performed during the normal working day

d. Written recall procedures are necessary as long as everyone knows what they are doing

32 / 60

Issues related to labeling or coding of batch details, secondary packaging material problems comes under the complaint?

a. Service complaint

b. Product complaint

c. Physical properties complaint

d. Packaging complaint

33 / 60

The assay depends on diffusion of the antibiotic from a vertical through a solidified agar layer in a Petri dish is the principle of?

a. Titration and Identification

b. The turbidimetric (or tube) assay

c. Spectrophotometry and Chromatographie (HPLC)

d. The cylinder-plate (or plate) assay

34 / 60

Contamination of a starting material, intermediate product or finished product with another starting material or product during production is?

a. In-process contamination

b. Contamination test

c. Cross-contamination

d. Impurity contamination

35 / 60

The laboratory results-out of specification (OOS) is reported by?

a. Production

b. Quality Control

c. Quality Assurance

d. All departments

36 / 60

If a complaint is received from customers, doctors, paramedics, clinics, hospitals, drugstores etc. the source of complaint is said to be?

a. External

b. Verbal

c. Internal

d. Written

37 / 60

Which of the following is NOT covered under Finished product quality assurance?

a. Finished product monitoring

b. Warehouse monitoring

c. None of these

d. Factory visits

38 / 60

La Module 3 du dossier CTD (ou ACTD) est décrit des informations concernent ?

a. La sécurité

b. La qualité

c. L’efficacité

d. L’information administrative

39 / 60

What is QA?

a. It is a corrective tool

b. Any systematic process used to ensure quality in the process

c. It is the measurement of degree to which a product satisfies the need

d. Process of identifying defects

40 / 60

In process control (Contrôle en cours de la fabrication) ធ្វើដើម្បី?

a. រកភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត

b. បញ្ជាក់ពីគុណភាពថ្នាំនៃឡូត៍ដែលបានផលិត

c. តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម!ដើម្បើដំណើរការម៉ាស៊ីនផលិត

d. បញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត

41 / 60

All documents associated with the manufacture of a batch of bulk product or finished product that provide a history of each batch of product is?

a. Batch number

b. Batch records

c. Common technical document (CTD)

d. Batch analysis

42 / 60

Choose incorrect sentence?

a. After SOP created, QA must verify work processing with SOP before approval.

b. Quality control procedure is under responsibility of quality control department.

c. QA is responsible of approval SOP and no need to write their own SOP

d. All department/unit need to write down the SOP procedure and follow the SOP approval.

43 / 60

A document that does exactly that it summarizes all the tests performed on a product and details the results with the specifications and analytical methods for laboratory analyses with signed is?

a. Manufacturing and packaging instructions

b. Certificate of Analysis

c. Laboratory control records

d. Validation protocols and reports

44 / 60

If a complaint is received from Production, Quality Control, Warehouse, Sales Department, the source is said to be?

a. Internal

b. Written

c. Verbal

d. External

45 / 60

To approve or reject the starting materials, packaging materials, intermediate, bulk and finished product is the responsibility of which department?

a. QA

b. QC

c. Production

d. Purchase

46 / 60

What is the purpose of conducting process validation in pharmaceutical manufacturing?

a. To improve marketing strategies

b. To ensure product efficacy

c. To minimize raw material costs

d. To optimize production speed

47 / 60

Receiving of wet Products is complaint associated with?

a. Packaging Complaint

b. Physical properties complaint

c. Product complaint

d. Delivery complaint

48 / 60

OOS is abbreviation used for?

a. Out of specification

b. Out of sterility

c. Out of stock

d. Out of storage

49 / 60

The finished products containing active ingredients should comply with ………………. composition of the marketing authorization.?

a. one of qualitative or quantitative

b. Qualitative

c. Quantitative

d. Both qualitative and quantitative

50 / 60

Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications is?

a. Validation process

b. Quality assurance check

c. Contamination correction

d. In-process control

51 / 60

If a complaint is received by email, the source of complaint is said to be?

a. External

b. Internal

c. Written

d. Verbal

52 / 60

Which phrase is described about deviation report system?

a. When product conform to specification, the deviation must be reported

b. Deviation report is written when receiving of raw materials

c. Deviation report is written by production staff after product manufacturing process

d. It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement to your processes and systems.

53 / 60

Two general techniques for antibiotics microbial assay are?

a. Titration and Identification

b. Qualitative and Quantitative

c. Spectrophotometry and Chromatographie (HPLC)

d. The cylinder-plate (or plate) assay and the turbidimetric (or tube) assay

54 / 60

Primary document to be reviewed in technical investigation stage of complaint handling is?

a. Complaint record files

b. Complaint samples

c. Retention sample

d. Batch records

55 / 60

The correct sequence for handling complaint is?

a. Receiving complaint, feedback to customer, Trend analysis of QC result, corrective actions, Investigation

b. Receiving complaint, Trend analysis of QC result, Investigation, feedback to customer, corrective actions

c. Receiving complaint, corrective actions, Investigation, feedback to customer, Trend analysis of QC result

d. Investigation, Receiving complaint, corrective actions, Trend analysis of QC result, feedback to customer

56 / 60

Responsibility of a complaint lies with?

a. Quality assurance head

b. Administration Unit head

c. All of above

d. Production head

57 / 60

The procedures of quality control laboratory are included, except?

a. Managing of analytical reagents

b. Laboratory waste management

c. Creation of certificate of analysis

d. Process validation

58 / 60

Any deviation occur can reported by?

a. Production

b. Quality Control

c. Quality Assurance

d. All departments

59 / 60

What is the purpose of conducting stability studies in pharmaceutical manufacturing?

a. To measure customer satisfaction

b. To assess the effectiveness of advertising campaigns

c. To determine employee productivity

d. To evaluate the shelf life of a product

60 / 60

Following this statement are general objectives of quality assurance, except?

a. Assuring the quality and traceability of finished product

b. Managing good manufacturing practices

c. Assuring the quality of raw materials

d. Managing of manufacturing plan

Your score is

The average score is 0%

Any comments?

Contrôle De Qualité II Test

Any problems/errors or mistakes found while testing, please let us know for modification!

និស្សិតអាចប្រាប់មកកាន់ពួកយើងបានដើម្បីកែកំហុស ឬអំពីបញ្ហាដោយអចេតនាណាមួយដែលកើតមានកំឡុងពេលធ្វើតេស្ត