Contrôle De Qualité II Test

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1 / 60

Receiving of wet Products is complaint associated with?

a. Product complaint

b. Physical properties complaint

c. Delivery complaint

d. Packaging Complaint

2 / 60

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

a. Factory visits

b. Warehouse monitoring

c. Finished product monitoring

d. None of these

3 / 60

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

a. Production and QC are independent to each other

b. Production is an integral part of QC

c. QC is an integral part of Production

d. QC may or may not depend on Production

4 / 60

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

a. To determine employee productivity

b. To assess the effectiveness of advertising campaigns

c. To evaluate the shelf life of a product

d. To measure customer satisfaction

5 / 60

An audit performed by an organization on itself is called a?

a. External audit

b. Self-inspection

c. Internal audit or self-inspection

d. Internal audit

6 / 60

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

a. Control chart

b. Complaint trend analysis

c. Check sheet

d. Scatter diagram

7 / 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

8 / 60

The correct sequence for handling complaint is?

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

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

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

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

9 / 60

Which of the following is an example of QA?

a. Product testing

b. Purchasing of raw materials

c. Verification

d. Process of mixing method

10 / 60

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

a. Returning of goods

b. Recalling of goods

c. Restoring of goods

d. Reporting of goods

11 / 60

Any deviation occur can reported by?

a. All departments

b. Production

c. Quality Control

d. Quality Assurance

12 / 60

What is QA?

a. It is a corrective tool

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

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

d. Process of identifying defects

13 / 60

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

a. All departments

b. Quality Control

c. Production

d. Quality Assurance

14 / 60

Any deviation occur can reported by?

a. Production

b. Quality Assurance

c. All departments

d. Quality Control

15 / 60

When there is probability by a product to cause serious health issues, it is?

a. Class II recall

b. Class I recall

c. All of the above

d. Class III recall

16 / 60

Issues related to foreign matter in a product is?

a. Product complaint

b. Physical properties complaint

c. Packaging complaint

d. Service complaint

17 / 60

The principle of laboratory results-out of specification is?

a. to re-testing of the sample

b. to validate of analytical method

c. to report the non-conformity of the test parameters

d. to release the certification of analysis

18 / 60

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

a. បញ្ជាក់ពីគុណភាពថ្នាំនៃឡូត៍ដែលបានផលិត

b. បញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត

c. រកភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត

d. តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម!ដើម្បើដំណើរការម៉ាស៊ីនផលិត

19 / 60

Which phrase is not correct about deviation report system?

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

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

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

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

20 / 60

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

a. No limit timeframe

b. 7 working days

c. 5 working days

d. 3 working days

21 / 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. The cylinder-plate (or plate) assay

b. Titration and Identification

c. Spectrophotometry and Chromatographie (HPLC)

d. The turbidimetric (or tube) assay

22 / 60

An area with defined environmental control of particulate and microbial contamination, is?

a. Quarantine zone

b. Production line

c. Airlock

d. Clean area

23 / 60

Complaints arising because of not keeping products under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product are affected are called as?

a. None

b. Accepted complaint

c. Non confirmed complaint

d. Confirmed complaint

24 / 60

When complaint & retained sample are in compliance with specification, Complaint sample is OOS due to misuse/ mishandling, it is?

a. Counterfeit complaint

b. Tampered complaint

c. Non confirmed complaint

d. Confirmed complaint

25 / 60

The procedures of quality control laboratory are included, except?

a. Laboratory result out of specification report

b. Retention samples laboratory

c. Stability study protocols

d. Self-inspection

26 / 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 analysis

c. Batch records

d. Common technical document (CTD)

27 / 60

What is the purpose of conducting internal audits in a pharmaceutical plant?

a. To identify and rectify quality issues

b. To evaluate employee performance

c. To increase sales revenue

d. To promote advertising campaigns

28 / 60

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

a. To confirm the accuracy of financial forecasts

b. To assess the market demand for a product

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

d. To determine the optimal production capacity

29 / 60

Two general techniques for antibiotics microbial assay are?

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

b. Qualitative and Quantitative

c. Spectrophotometry and Chromatographie (HPLC)

d. Titration and Identification

30 / 60

The main objective of quality assurance is?

a. Customer satisfaction

b. Inspection of quality of product

c. Proof of fitness of product

d. Quality conformance

31 / 60

What is the main objective of quality assurance in a pharmaceutical plant?

a. To maximize profit margins

b. To maximize production efficiency

c. To ensure compliance with regulatory standard

d. To minimize manufacturing costs

32 / 60

18-Which of following statement(s) is/are about quality assurance (A. QA is a set of activities for ensuring quality in the processes by which products are developed. / B. QA is a corrective action and product oriented.)?

a. B is correct

b. Both A and B

c. None of these

d. A is correct

33 / 60

The procedures of quality control laboratory are included, except?

a. Managing of analytical reagents

b. Laboratory waste management

c. Process validation

d. Creation of certificate of analysis

34 / 60

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

a. Increase production speed

b. Maximize shareholder value

c. Continuous improvement

d. Reduce employee turnover

35 / 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. The cylinder-plate (or plate) assay

c. Titration and Identification

d. The turbidimetric (or tube) assay

36 / 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. Purchase

b. QC

c. QA

d. Production

37 / 60

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

a. Managing of manufacturing plan

b. Managing good manufacturing practices

c. Assuring the quality of raw materials

d. Assuring the quality and traceability of finished product

38 / 60

A Preventive Action is put in place to?

a. Identify the reason a nonconformity occurred

b. Identify a nonconformity

c. Make you work on a device longer

d. Eliminate a potential cause of a nonconformity

39 / 60

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

a. Quality control

b. Quality improvement

c. Quality management

d. Quality assessment

40 / 60

Quality Control involved in pharmaceutical manufacturing process from?

a. Sampling of starting materials to batch release for sale

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

c. Purchase of starting materials to batch release for sale

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

41 / 60

What is the purpose of analytical method validation in the pharmaceutical industry?

a. To assess the effectiveness of marketing campaigns

b. To monitor employee performance

c. To evaluate the efficiency of manufacturing processes

d. To ensure the accuracy and reliability of test results

42 / 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. Certificate of Analysis

b. Laboratory control records

c. Validation protocols and reports

d. Manufacturing and packaging instructions

43 / 60

The activity (potency) of antibiotics can be demonstrated by their inhibitory effect on microorganisms. The method can be used for analysis is?

a. Titration, Spectrophotometry, Chromatographie (HPLC)

b. microbiological assay

c. Melting point, Solubility

d. Character, Identification

44 / 60

Définition de la spécification ?

a. Capacité de la méthode dans un intervalle donné d'obtenir des résultats de dosage directement proportionnels à la concentration ou à la quantité d'analyte dans l'échantillon

b. Capacité de la méthode de permettre une évaluation non équivoque de l'analyte en présence de composants qui sont susceptibles d'être présents

c. Liste d'analyses avec les références à des procédures analytiques et les critères d'acceptation appropriées

d. Ensemble des activités destinées à maintenir ou à rétablir un bien dans un état ou dans des conditions données de sûreté de fonctionnement

45 / 60

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

a. Complaint record files

b. Batch records

c. Complaint samples

d. Retention sample

46 / 60

The procedures of quality control laboratory are included, except?

a. Calibration policies for laboratory instruments

b. Management of reference substances

c. Retest dating of raw materials

d. Deviation reporting approval

47 / 60

Which of the following is not an essential element of a quality management system in a pharmaceutical plant?

a. Document control

b. Risk management

c. Training programs

d. Cost reduction strategies

48 / 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

49 / 60

Choose incorrect sentence?

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

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

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

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

50 / 60

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

a. Quantitative

b. Qualitative

c. one of qualitative or quantitative

d. Both qualitative and quantitative

51 / 60

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

a. 3 working days

b. 5 working days

c. No limit timeframe

d. 7 working days

52 / 60

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

a. Physical properties complaint

b. Service complaint

c. Packaging complaint

d. Product complaint

53 / 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

54 / 60

Which of the following department holds responsibilities for quality monitoring or audit?

a. QA

b. Purchase

c. Production

d. QC

55 / 60

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

a. Cross-contamination

b. Contamination test

c. In-process contamination

d. Impurity contamination

56 / 60

Bulk/ finished product when sent back to Manufacturer, distributor, importer is known as?

a. Expired goods

b. Recalled goods

c. Received goods

d. Returned goods

57 / 60

When only complaint sample is OOS, with no definite reason, like packaging material is different etc. it is referred as?

a. Confirmed complaint

b. Tampered complaint

c. Counterfeit complaint

d. Non confirmed complaint

58 / 60

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

a. Written

b. Internal

c. Verbal

d. External

59 / 60

Choose the correct sentence?

a. QC is responsible of approval SOP.

b. Production department is depending on QA operating procedure.

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

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

60 / 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. Certificate of Analysis

b. Validation protocols and reports

c. Laboratory control records

d. Manufacturing and packaging instructions

Your score is

The average score is 77%

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Contrôle De Qualité II Test

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និស្សិតអាចប្រាប់មកកាន់ពួកយើងបានដើម្បីកែកំហុស ឬអំពីបញ្ហាដោយអចេតនាណាមួយដែលកើតមានកំឡុងពេលធ្វើតេស្ត