Contrôle De Qualité II Test

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1 / 60

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

a. Verbal

b. Internal

c. External

d. Written

2 / 60

What is the reason for initiating a CAPA?

a. To deviate from a Work Instruction

b. To eliminate a nonconformity

c. To make a risk assessment

d. To rework a product

3 / 60

OOS is abbreviation used for?

a. Out of specification

b. Out of storage

c. Out of sterility

d. Out of stock

4 / 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. Validation protocols and reports

c. Laboratory control records

d. Certificate of Analysis

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

Receiving of wet Products is complaint associated with?

a. Packaging Complaint

b. Delivery complaint

c. Physical properties complaint

d. Product complaint

7 / 60

Quality Control involved in pharmaceutical manufacturing process from?

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

b. Sampling of starting materials to batch release for sale

c. Purchase of starting materials to batch release for sale

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

8 / 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

9 / 60

Which one is part of quality management focused on providing confidence that quality requirement will be fulfilled?

a. Quality control

b. Quality system

c. Quality sampling

d. Quality assurance

10 / 60

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

a. L’efficacité

b. L’information administrative

c. La sécurité

d. La qualité

11 / 60

Choose the correct sentence?

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

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

c. QC is responsible of approval SOP.

d. Production department is depending on QA operating procedure.

12 / 60

Which QMS tool helps in understanding the cause-and-effect relationship between various factors influencing a problem?

a. Control chart

b. Histogram

c. Scatter diagram

d. Fishbone diagram

13 / 60

The procedures of quality control laboratory are included, except?

a. Retest dating of raw materials

b. Management of reference substances

c. Deviation reporting approval

d. Calibration policies for laboratory instruments

14 / 60

Which type of validation is conducted during the initial installation of a new piece of equipment?

a. Analytical method validation

b. Process validation

c. Cleaning validation

d. Equipment qualification

15 / 60

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

a. Non confirmed complaint

b. Tampered complaint

c. Counterfeit complaint

d. Confirmed complaint

16 / 60

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

a. Production line

b. Airlock

c. Clean area

d. Quarantine zone

17 / 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

18 / 60

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

a. Returned goods

b. Received goods

c. Expired goods

d. Recalled goods

19 / 60

Which phrase is not correct about deviation report system?

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

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

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

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

20 / 60

The procedures of quality control laboratory are included, except?

a. Self-inspection

b. Laboratory result out of specification report

c. Retention samples laboratory

d. Stability study protocols

21 / 60

The correct sequence for handling complaint is?

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

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

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

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

22 / 60

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

a. To quality control limits

b. To calculate financial ratios

c. To define employee work schedules

d. To outline manufacturing processes

23 / 60

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate product is?

a. Contamination

b. Cross-contamination

c. In-process control

d. Degradation

24 / 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 confirm the accuracy of financial forecasts

c. To assess the market demand for a product

d. To determine the optimal production capacity

25 / 60

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

a. To ensure product efficacy

b. To minimize raw material costs

c. To improve marketing strategies

d. To optimize production speed

26 / 60

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

a. Recalled goods

b. Returned goods

c. Received goods

d. Expired goods

27 / 60

Issues related to foreign matter in a product is?

a. Service complaint

b. Physical properties complaint

c. Product complaint

d. Packaging complaint

28 / 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.

29 / 60

Any deviation occur can reported by?

a. All departments

b. Quality Control

c. Quality Assurance

d. Production

30 / 60

What is QA?

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

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

c. Process of identifying defects

d. It is a corrective tool

31 / 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 of starting materials to batch release for sale

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

32 / 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. Production scheduling

c. Statistical process control

d. Inventory management

33 / 60

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

a. QA

b. QC

c. Purchase

d. Production

34 / 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. Confirmed complaint

c. Non confirmed complaint

d. Accepted complaint

35 / 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

36 / 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. In-process control

b. Contamination correction

c. Quality assurance check

d. Validation process

37 / 60

Two general techniques for antibiotics microbial assay are?

a. Qualitative and Quantitative

b. Titration and Identification

c. Spectrophotometry and Chromatographie (HPLC)

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

38 / 60

A Preventive Action is put in place to?

a. Eliminate a potential cause of a nonconformity

b. Identify a nonconformity

c. Identify the reason a nonconformity occurred

d. Make you work on a device longer

39 / 60

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

a. None of these

b. Warehouse monitoring

c. Factory visits

d. Finished product monitoring

40 / 60

Choose the correct sentence?

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

b. deviation is reported by QC after every batch analysis

c. Only quality assurance can report of deviation

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

41 / 60

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

a. Purchase

b. Production

c. QC

d. QA

42 / 60

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

a. Restoring of goods

b. Reporting of goods

c. Recalling of goods

d. Returning of goods

43 / 60

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

a. Assuring the quality of raw materials

b. Managing good manufacturing practices

c. Assuring the quality and traceability of finished product

d. Managing of manufacturing plan

44 / 60

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

a. Class III recall

b. Class II recall

c. All of the above

d. Class I recall

45 / 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. The turbidimetric (or tube) assay

b. Spectrophotometry and Chromatographie (HPLC)

c. The cylinder-plate (or plate) assay

d. Titration and Identification

46 / 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 records

b. Batch analysis

c. Common technical document (CTD)

d. Batch number

47 / 60

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

a. To ensure compliance with regulatory standard

b. To minimize manufacturing costs

c. To maximize profit margins

d. To maximize production efficiency

48 / 60

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

a. Cleaning validation

b. Change control validation

c. Process validation

d. Analytical method validation

49 / 60

The following statements are true, except?

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

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. All complaints must be reviewed according to written procedures

50 / 60

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

a. តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម!ដើម្បើដំណើរការម៉ាស៊ីនផលិត

b. រកភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត

c. បញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត

d. បញ្ជាក់ពីគុណភាពថ្នាំនៃឡូត៍ដែលបានផលិត

51 / 60

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

a. Scatter diagram

b. Control chart

c. Check sheet

d. Complaint trend analysis

52 / 60

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

a. To evaluate the efficiency of manufacturing processes

b. To ensure the accuracy and reliability of test results

c. To assess the effectiveness of marketing campaigns

d. To monitor employee performance

53 / 60

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

a. Both qualitative and quantitative

b. one of qualitative or quantitative

c. Qualitative

d. Quantitative

54 / 60

The principle of laboratory results-out of specification is?

a. to validate of analytical method

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

c. to release the certification of analysis

d. to re-testing of the sample

55 / 60

La bonne pratique de fabrication (BPF) est appliquée ?

a. laboratoire biologie et production de médicament

b. à la fois à la production et au contrôle de la qualité des médicaments

c. laboratoire de toxicologie, laboratoires de l’industrie chimique et laboratoires de recherche de chimie

d. laboratoire de contrôle qualité du médicament

56 / 60

Evaluating the Root Cause of a nonconformance happens in which stage of a CAPA?

a. Investigate and Plan

b. Submit a CAPA Request

c. Implement and Verify

d. Closure

57 / 60

The procedures of quality control laboratory are included, except?

a. Managing of analytical reagents

b. Process validation

c. Laboratory waste management

d. Creation of certificate of analysis

58 / 60

Which department is typically responsible for implementing and maintaining a quality management system in a pharmaceutical plant?

a. Sales and marketing

b. Quality assurance (QA)

c. Research and development (RD)

d. Human resources (HR)

59 / 60

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

a. Global manufacturing protocols

b. Generic manufacturing procedures

c. Good manufacturing practices

d. General manufacturing principles

60 / 60

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

a. Increase production speed

b. Reduce employee turnover

c. Continuous improvement

d. Maximize shareholder value

Your score is

The average score is 61%

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Contrôle De Qualité II Test

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និស្សិតអាចប្រាប់មកកាន់ពួកយើងបានដើម្បីកែកំហុស ឬអំពីបញ្ហាដោយអចេតនាណាមួយដែលកើតមានកំឡុងពេលធ្វើតេស្ត