Contrôle De Qualité II Test

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1 / 60

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

a. To evaluate employee performance

b. To increase sales revenue

c. To identify and rectify quality issues

d. To promote advertising campaigns

2 / 60

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

a. Class III recall

b. Class I recall

c. All of the above

d. Class II recall

3 / 60

Which phrase is described about deviation report system?

a. 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.

b. Deviation report is written when receiving of raw materials

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

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

4 / 60

Quality Assurance involved in pharmaceutical manufacturing process from?

a. Sampling of starting materials to batch release for sale

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

5 / 60

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

a. Production

b. Quality Assurance

c. All departments

d. Quality Control

6 / 60

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

a. Written

b. Internal

c. Verbal

d. External

7 / 60

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

a. Quality management

b. Quality improvement

c. Quality control

d. Quality assessment

8 / 60

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

a. Research and development (RD)

b. Quality assurance (QA)

c. Human resources (HR)

d. Sales and marketing

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

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

a. Confirmed complaint

b. Non confirmed complaint

c. Counterfeit complaint

d. Tampered complaint

11 / 60

Choose the correct sentence?

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

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

c. deviation is reported by QC after every batch analysis

d. Only quality assurance can report of deviation

12 / 60

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

a. Contamination test

b. Impurity contamination

c. Cross-contamination

d. In-process contamination

13 / 60

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

a. 3 working days

b. 7 working days

c. 5 working days

d. No limit timeframe

14 / 60

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

a. To evaluate the shelf life of a product

b. To measure customer satisfaction

c. To assess the effectiveness of advertising campaigns

d. To determine employee productivity

15 / 60

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

a. Implement and Verify

b. Closure

c. Submit a CAPA Request

d. Investigate and Plan

16 / 60

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

a. To ensure product efficacy

b. To optimize production speed

c. To improve marketing strategies

d. To minimize raw material costs

17 / 60

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

a. Internal audit or self-inspection

b. Self-inspection

c. External audit

d. Internal audit

18 / 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. Validation protocols and reports

b. Manufacturing and packaging instructions

c. Certificate of Analysis

d. Laboratory control records

19 / 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. Clean area

c. Airlock

d. Quarantine zone

20 / 60

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

a. Cost reduction strategies

b. Training programs

c. Risk management

d. Document control

21 / 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.

22 / 60

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

a. Written

b. Internal

c. Verbal

d. External

23 / 60

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

a. To outline manufacturing processes

b. To quality control limits

c. To define employee work schedules

d. To calculate financial ratios

24 / 60

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

a. Received goods

b. Expired goods

c. Returned goods

d. Recalled goods

25 / 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

26 / 60

Issues related to foreign matter in a product is?

a. Service complaint

b. Packaging complaint

c. Physical properties complaint

d. Product complaint

27 / 60

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

a. Restoring of goods

b. Recalling of goods

c. Reporting of goods

d. Returning of goods

28 / 60

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

a. Installation qualification (IQ)

b. Process design qualification (PDQ)

c. Operation qualification (OQ)

d. Performance qualification (PQ)

29 / 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 sampling for quality control of finished product

c. Sampling of starting materials to batch release for sale

d. Purchase of starting materials to batch release for sale

30 / 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. Confirmed complaint

b. None

c. Non confirmed complaint

d. Accepted complaint

31 / 60

What is the reason for initiating a CAPA?

a. To eliminate a nonconformity

b. To make a risk assessment

c. To deviate from a Work Instruction

d. To rework a product

32 / 60

Any deviation occur can reported by?

a. Quality Control

b. Production

c. All departments

d. Quality Assurance

33 / 60

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

a. Complaint trend analysis

b. Scatter diagram

c. Check sheet

d. Control chart

34 / 60

The procedures of quality control laboratory are included, except?

a. Creation of certificate of analysis

b. Managing of analytical reagents

c. Laboratory waste management

d. Process validation

35 / 60

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

a. Product complaint

b. Packaging complaint

c. Service complaint

d. Physical properties complaint

36 / 60

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

a. Production is an integral part of QC

b. QC may or may not depend on Production

c. Production and QC are independent to each other

d. QC is an integral part of Production

37 / 60

Which phrase is not correct about deviation report system?

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

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

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

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

38 / 60

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

a. Tampered complaint

b. Non confirmed complaint

c. Counterfeit complaint

d. Confirmed complaint

39 / 60

Choose incorrect sentence?

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

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

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

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

40 / 60

The main objective of quality assurance is?

a. Quality conformance

b. Proof of fitness of product

c. Customer satisfaction

d. Inspection of quality of product

41 / 60

What is QA?

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

b. Process of identifying defects

c. It is a corrective tool

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

42 / 60

Responsibility of a complaint lies with?

a. Production head

b. Administration Unit head

c. All of above

d. Quality assurance head

43 / 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

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

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

a. Class IV recall

b. Class I recall

c. Class III recall

d. Class II recall

46 / 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. Both A and B

b. A is correct

c. B is correct

d. None of these

47 / 60

OOS is abbreviation used for?

a. Out of specification

b. Out of sterility

c. Out of stock

d. Out of storage

48 / 60

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

a. L’efficacité

b. La qualité

c. L’information administrative

d. La sécurité

49 / 60

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

a. Quarantine zone

b. Clean area

c. Airlock

d. Production line

50 / 60

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

a. Received goods

b. Returned goods

c. Recalled goods

d. Expired goods

51 / 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

52 / 60

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

a. Global manufacturing protocols

b. General manufacturing principles

c. Good manufacturing practices

d. Generic manufacturing procedures

53 / 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 turbidimetric (or tube) assay

b. The cylinder-plate (or plate) assay

c. Titration and Identification

d. Spectrophotometry and Chromatographie (HPLC)

54 / 60

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

a. QC

b. Purchase

c. Production

d. QA

55 / 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. Character, Identification

d. Melting point, Solubility

56 / 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 contrôle qualité du médicament

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

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. Certificate of Analysis

b. Laboratory control records

c. Manufacturing and packaging instructions

d. Validation protocols and reports

58 / 60

The entry in Batch Manufacturing Record is done by?

a. Warehouse department

b. Production department

c. Quality control department

d. Quality assurance department

59 / 60

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

a. Inventory management

b. Statistical process control

c. Production scheduling

d. High-performance liquid chromatography (HPLC)

60 / 60

A Preventive Action is put in place to?

a. Identify the reason a nonconformity occurred

b. Make you work on a device longer

c. Identify a nonconformity

d. Eliminate a potential cause of a nonconformity

Your score is

The average score is 61%

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Contrôle De Qualité II Test

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