Contrôle De Qualité II Test

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1 / 60

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

a. To assess the market demand for a product

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

c. To confirm the accuracy of financial forecasts

d. To determine the optimal production capacity

2 / 60

The principle of laboratory results-out of specification is?

a. to release the certification of analysis

b. to validate of analytical method

c. to re-testing of the sample

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

3 / 60

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

a. QC may or may not depend on Production

b. Production is an integral part of QC

c. QC is an integral part of Production

d. Production and QC are independent to each other

4 / 60

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

a. Internal audit or self-inspection

b. External audit

c. Internal audit

d. Self-inspection

5 / 60

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

a. Managing of manufacturing plan

b. Assuring the quality of raw materials

c. Assuring the quality and traceability of finished product

d. Managing good manufacturing practices

6 / 60

Any deviation occur can reported by?

a. Quality Assurance

b. Production

c. Quality Control

d. All departments

7 / 60

A Preventive Action is put in place to?

a. Identify a nonconformity

b. Make you work on a device longer

c. Eliminate a potential cause of a nonconformity

d. Identify the reason a nonconformity occurred

8 / 60

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

a. Performance qualification (PQ)

b. Installation qualification (IQ)

c. Operation qualification (OQ)

d. Process design qualification (PDQ)

9 / 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

10 / 60

The entry in Batch Manufacturing Record is done by?

a. Warehouse department

b. Quality control department

c. Production department

d. Quality assurance department

11 / 60

Which phrase is described about deviation report system?

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

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

c. Deviation report is written when receiving of raw materials

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.

12 / 60

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

a. Production scheduling

b. High-performance liquid chromatography (HPLC)

c. Inventory management

d. Statistical process control

13 / 60

Any deviation occur can reported by?

a. All departments

b. Quality Assurance

c. Production

d. Quality Control

14 / 60

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

a. Returned goods

b. Recalled goods

c. Received goods

d. Expired goods

15 / 60

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

a. Internal

b. Written

c. External

d. Verbal

16 / 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. Contamination correction

b. Validation process

c. In-process control

d. Quality assurance check

17 / 60

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

a. Reduce employee turnover

b. Increase production speed

c. Maximize shareholder value

d. Continuous improvement

18 / 60

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

a. To evaluate employee performance

b. To promote advertising campaigns

c. To identify and rectify quality issues

d. To increase sales revenue

19 / 60

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

a. Class III recall

b. Class I recall

c. Class II recall

d. All of the above

20 / 60

The procedures of quality control laboratory are included, except?

a. Retention samples laboratory

b. Laboratory result out of specification report

c. Stability study protocols

d. Self-inspection

21 / 60

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

a. Verbal

b. Internal

c. External

d. Written

22 / 60

Choose the correct sentence?

a. deviation is reported by QC after every batch analysis

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. Only quality assurance can report of deviation

23 / 60

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

a. Purchase

b. Production

c. QA

d. QC

24 / 60

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

a. Equipment qualification

b. Process validation

c. Cleaning validation

d. Analytical method validation

25 / 60

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

a. Impurity contamination

b. In-process contamination

c. Contamination test

d. Cross-contamination

26 / 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.

27 / 60

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

a. Closure

b. Investigate and Plan

c. Implement and Verify

d. Submit a CAPA Request

28 / 60

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

a. Quality assessment

b. Quality management

c. Quality improvement

d. Quality control

29 / 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. Confirmed complaint

d. Non confirmed complaint

30 / 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

31 / 60

The following statements are true, except?

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

b. All complaints must be reviewed according to written procedures

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

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

32 / 60

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

a. Retention sample

b. Complaint samples

c. Batch records

d. Complaint record files

33 / 60

The procedures of quality control laboratory are included, except?

a. Calibration policies for laboratory instruments

b. Retest dating of raw materials

c. Deviation reporting approval

d. Management of reference substances

34 / 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 analysis

b. Batch number

c. Common technical document (CTD)

d. Batch records

35 / 60

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

a. Analytical method validation

b. Cleaning validation

c. Process validation

d. Change control validation

36 / 60

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

a. To monitor employee performance

b. To ensure the accuracy and reliability of test results

c. To evaluate the efficiency of manufacturing processes

d. To assess the effectiveness of marketing campaigns

37 / 60

Which of the following is an example of QA?

a. Product testing

b. Purchasing of raw materials

c. Process of mixing method

d. Verification

38 / 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, feedback to customer, Trend analysis of QC result, corrective actions, Investigation

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

39 / 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

40 / 60

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

a. Warehouse monitoring

b. Factory visits

c. None of these

d. Finished product monitoring

41 / 60

Quality Control involved in pharmaceutical manufacturing process from?

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

b. Purchase of starting materials to batch release for sale

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

d. Sampling of starting materials to batch release for sale

42 / 60

What is the reason for initiating a CAPA?

a. To make a risk assessment

b. To eliminate a nonconformity

c. To deviate from a Work Instruction

d. To rework a product

43 / 60

Définition de la spécification ?

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

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

c. 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

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

44 / 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

45 / 60

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

a. La qualité

b. L’efficacité

c. La sécurité

d. L’information administrative

46 / 60

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

a. Production

b. QA

c. Purchase

d. QC

47 / 60

Choose the correct sentence?

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

b. Production department is depending on QA operating procedure.

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

d. QC is responsible of approval SOP.

48 / 60

The procedures of quality control laboratory are included, except?

a. Process validation

b. Managing of analytical reagents

c. Laboratory waste management

d. Creation of certificate of analysis

49 / 60

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

a. 3 working days

b. 5 working days

c. 7 working days

d. No limit timeframe

50 / 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. Airlock

b. Production line

c. Clean area

d. Quarantine zone

51 / 60

Quality Assurance 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 sampling for quality control of finished product

c. Purchase of starting materials to batch release for sale

d. Sampling of starting materials to batch release for sale

52 / 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. Degradation

d. In-process control

53 / 60

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

a. Quality control

b. Quality assurance

c. Quality system

d. Quality sampling

54 / 60

Receiving of wet Products is complaint associated with?

a. Physical properties complaint

b. Delivery complaint

c. Product complaint

d. Packaging Complaint

55 / 60

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

a. Quality assurance (QA)

b. Research and development (RD)

c. Sales and marketing

d. Human resources (HR)

56 / 60

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

a. Physical properties complaint

b. Packaging complaint

c. Product complaint

d. Service complaint

57 / 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. Laboratory control records

b. Manufacturing and packaging instructions

c. Certificate of Analysis

d. Validation protocols and reports

58 / 60

La bonne pratique de fabrication (BPF) est appliquée ?

a. laboratoire de contrôle qualité du médicament

b. laboratoire biologie et production de médicament

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

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

59 / 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. Melting point, Solubility

c. Character, Identification

d. microbiological assay

60 / 60

Choose incorrect sentence?

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

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

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

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

Your score is

The average score is 49%

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Contrôle De Qualité II Test

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