Contrôle De Qualité II Test

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1 / 60

Définition de la spécification ?

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

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

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

2 / 60

Any deviation occur can reported by?

a. All departments

b. Quality Control

c. Quality Assurance

d. Production

3 / 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

4 / 60

The entry in Batch Manufacturing Record is done by?

a. Warehouse department

b. Quality assurance department

c. Quality control department

d. Production department

5 / 60

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

a. Quality improvement

b. Quality control

c. Quality management

d. Quality assessment

6 / 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 determine the optimal production capacity

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

7 / 60

La bonne pratique de fabrication (BPF) est appliquée ?

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

b. laboratoire de contrôle qualité du médicament

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

d. laboratoire biologie et production de médicament

8 / 60

The procedures of quality control laboratory are included, except?

a. Laboratory result out of specification report

b. Stability study protocols

c. Retention samples laboratory

d. Self-inspection

9 / 60

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

a. Check sheet

b. Control chart

c. Scatter diagram

d. Complaint trend analysis

10 / 60

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

a. 5 working days

b. No limit timeframe

c. 3 working days

d. 7 working days

11 / 60

Choose the correct sentence?

a. Only quality assurance can report of deviation

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

c. deviation is reported by QC after every batch analysis

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

12 / 60

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

a. Expired goods

b. Returned goods

c. Received goods

d. Recalled goods

13 / 60

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

a. Impurity contamination

b. Contamination test

c. Cross-contamination

d. In-process contamination

14 / 60

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

a. L’information administrative

b. La qualité

c. La sécurité

d. L’efficacité

15 / 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. QA

c. Purchase

d. QC

16 / 60

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

a. Verbal

b. Internal

c. Written

d. External

17 / 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. Laboratory control records

c. Manufacturing and packaging instructions

d. Certificate of Analysis

18 / 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. In-process control

b. Degradation

c. Contamination

d. Cross-contamination

19 / 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

20 / 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

21 / 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. QC is an integral part of Production

d. Production and QC are independent to each other

22 / 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. Process design qualification (PDQ)

c. Operation qualification (OQ)

d. Installation qualification (IQ)

23 / 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 number

c. Batch analysis

d. Common technical document (CTD)

24 / 60

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

a. Human resources (HR)

b. Quality assurance (QA)

c. Research and development (RD)

d. Sales and marketing

25 / 60

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

a. Purchase

b. QA

c. QC

d. Production

26 / 60

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

a. Expired goods

b. Recalled goods

c. Returned goods

d. Received goods

27 / 60

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

a. Cleaning validation

b. Process validation

c. Equipment qualification

d. Analytical method validation

28 / 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 outline manufacturing processes

d. To define employee work schedules

29 / 60

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

a. Good manufacturing practices

b. Global manufacturing protocols

c. Generic manufacturing procedures

d. General manufacturing principles

30 / 60

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

a. To ensure the accuracy and reliability of test results

b. To evaluate the efficiency of manufacturing processes

c. To monitor employee performance

d. To assess the effectiveness of marketing campaigns

31 / 60

Responsibility of a complaint lies with?

a. Production head

b. All of above

c. Administration Unit head

d. Quality assurance head

32 / 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

33 / 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. No limit timeframe

c. 3 working days

d. 7 working days

34 / 60

What is the reason for initiating a CAPA?

a. To eliminate a nonconformity

b. To deviate from a Work Instruction

c. To rework a product

d. To make a risk assessment

35 / 60

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

a. បញ្ជាក់ពីគុណភាពថ្នាំនៃឡូត៍ដែលបានផលិត

b. តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម!ដើម្បើដំណើរការម៉ាស៊ីនផលិត

c. បញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត

d. រកភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត

36 / 60

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

a. Reduce employee turnover

b. Continuous improvement

c. Increase production speed

d. Maximize shareholder value

37 / 60

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

a. Confirmed complaint

b. Counterfeit complaint

c. Non confirmed complaint

d. Tampered complaint

38 / 60

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

a. Factory visits

b. Finished product monitoring

c. None of these

d. Warehouse monitoring

39 / 60

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

a. Cost reduction strategies

b. Risk management

c. Document control

d. Training programs

40 / 60

Which of the following is an example of QA?

a. Purchasing of raw materials

b. Verification

c. Process of mixing method

d. Product testing

41 / 60

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

a. Returning of goods

b. Restoring of goods

c. Recalling of goods

d. Reporting of goods

42 / 60

OOS is abbreviation used for?

a. Out of stock

b. Out of specification

c. Out of sterility

d. Out of storage

43 / 60

Receiving of wet Products is complaint associated with?

a. Product complaint

b. Physical properties complaint

c. Packaging Complaint

d. Delivery complaint

44 / 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

45 / 60

The main objective of quality assurance is?

a. Proof of fitness of product

b. Inspection of quality of product

c. Quality conformance

d. Customer satisfaction

46 / 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

47 / 60

The principle of laboratory results-out of specification is?

a. to release the certification of analysis

b. to re-testing of the sample

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

d. to validate of analytical method

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

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

49 / 60

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

a. To ensure product efficacy

b. To improve marketing strategies

c. To minimize raw material costs

d. To optimize production speed

50 / 60

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

a. Packaging complaint

b. Product complaint

c. Physical properties complaint

d. Service complaint

51 / 60

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

a. Quality Assurance

b. All departments

c. Production

d. Quality Control

52 / 60

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

a. Closure

b. Submit a CAPA Request

c. Investigate and Plan

d. Implement and Verify

53 / 60

Choose incorrect sentence?

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

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

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

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

54 / 60

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

a. Internal

b. External

c. Written

d. Verbal

55 / 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

56 / 60

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

a. Class I recall

b. Class IV recall

c. Class II recall

d. Class III recall

57 / 60

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

a. To minimize manufacturing costs

b. To maximize profit margins

c. To ensure compliance with regulatory standard

d. To maximize production efficiency

58 / 60

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

a. Quality assurance

b. Quality sampling

c. Quality control

d. Quality system

59 / 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

60 / 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, capture data, analysis, investigation, determination of assignable causes.

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

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

Your score is

The average score is 61%

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Contrôle De Qualité II Test

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និស្សិតអាចប្រាប់មកកាន់ពួកយើងបានដើម្បីកែកំហុស ឬអំពីបញ្ហាដោយអចេតនាណាមួយដែលកើតមានកំឡុងពេលធ្វើតេស្ត