Contrôle De Qualité II Test

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1 / 60

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

a. Both qualitative and quantitative

b. Quantitative

c. one of qualitative or quantitative

d. Qualitative

2 / 60

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

a. To outline manufacturing processes

b. To calculate financial ratios

c. To quality control limits

d. To define employee work schedules

3 / 60

Choose the correct sentence?

a. Production department is depending on QA operating procedure.

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

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

d. QC is responsible of approval SOP.

4 / 60

Receiving of wet Products is complaint associated with?

a. Product complaint

b. Delivery complaint

c. Packaging Complaint

d. Physical properties complaint

5 / 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

6 / 60

Issues related to foreign matter in a product is?

a. Physical properties complaint

b. Service complaint

c. Packaging complaint

d. Product complaint

7 / 60

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

a. Control chart

b. Fishbone diagram

c. Histogram

d. Scatter diagram

8 / 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. Degradation

b. In-process control

c. Contamination

d. Cross-contamination

9 / 60

Quality Assurance involved in pharmaceutical manufacturing process from?

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

10 / 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

11 / 60

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

a. Internal audit

b. Internal audit or self-inspection

c. External audit

d. Self-inspection

12 / 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 can only be performed during the normal working day

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

d. All complaints must be reviewed according to written procedures

13 / 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. Certificate of Analysis

c. Validation protocols and reports

d. Laboratory control records

14 / 60

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

a. Melting point, Solubility

b. microbiological assay

c. Character, Identification

d. Titration, Spectrophotometry, Chromatographie (HPLC)

15 / 60

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

a. Managing of manufacturing plan

b. Assuring the quality and traceability of finished product

c. Managing good manufacturing practices

d. Assuring the quality of raw materials

16 / 60

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

a. Verbal

b. Written

c. External

d. Internal

17 / 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. General manufacturing principles

d. Generic manufacturing procedures

18 / 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

19 / 60

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

a. Production and QC are independent to each other

b. QC is an integral part of Production

c. Production is an integral part of QC

d. QC may or may not depend on Production

20 / 60

OOS is abbreviation used for?

a. Out of storage

b. Out of sterility

c. Out of specification

d. Out of stock

21 / 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

22 / 60

Two general techniques for antibiotics microbial assay are?

a. Spectrophotometry and Chromatographie (HPLC)

b. Titration and Identification

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

d. Qualitative and Quantitative

23 / 60

Choose incorrect sentence?

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

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

24 / 60

The procedures of quality control laboratory are included, except?

a. Retention samples laboratory

b. Laboratory result out of specification report

c. Self-inspection

d. Stability study protocols

25 / 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

26 / 60

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

a. La sécurité

b. L’efficacité

c. L’information administrative

d. La qualité

27 / 60

What is the reason for initiating a CAPA?

a. To rework a product

b. To make a risk assessment

c. To eliminate a nonconformity

d. To deviate from a Work Instruction

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 determine the optimal production capacity

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

29 / 60

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

a. To optimize production speed

b. To ensure product efficacy

c. To minimize raw material costs

d. To improve marketing strategies

30 / 60

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

a. To measure customer satisfaction

b. To determine employee productivity

c. To assess the effectiveness of advertising campaigns

d. To evaluate the shelf life of a product

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

c. Deviation report is written when receiving of raw materials

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

32 / 60

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

a. Tampered complaint

b. Non confirmed complaint

c. Counterfeit complaint

d. Confirmed complaint

33 / 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

34 / 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

35 / 60

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

a. Written

b. External

c. Internal

d. Verbal

36 / 60

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

a. Training programs

b. Cost reduction strategies

c. Document control

d. Risk management

37 / 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. Quarantine zone

d. Clean area

38 / 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

39 / 60

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

a. Class III recall

b. Class II recall

c. Class IV recall

d. Class I recall

40 / 60

The procedures of quality control laboratory are included, except?

a. Process validation

b. Laboratory waste management

c. Creation of certificate of analysis

d. Managing of analytical reagents

41 / 60

The correct sequence for handling complaint is?

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

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

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

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

42 / 60

Which of the following is an example of QA?

a. Product testing

b. Process of mixing method

c. Verification

d. Purchasing of raw materials

43 / 60

A Preventive Action is put in place to?

a. Identify the reason a nonconformity occurred

b. Identify a nonconformity

c. Eliminate a potential cause of a nonconformity

d. Make you work on a device longer

44 / 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

45 / 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. Returning of goods

d. Reporting of goods

46 / 60

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

a. Production

b. Quality Control

c. All departments

d. Quality Assurance

47 / 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

48 / 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

49 / 60

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

a. Human resources (HR)

b. Research and development (RD)

c. Quality assurance (QA)

d. Sales and marketing

50 / 60

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

a. Verbal

b. Written

c. Internal

d. External

51 / 60

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

a. Increase production speed

b. Continuous improvement

c. Reduce employee turnover

d. Maximize shareholder value

52 / 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 increase sales revenue

d. To identify and rectify quality issues

53 / 60

Any deviation occur can reported by?

a. Quality Assurance

b. Quality Control

c. Production

d. All departments

54 / 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. Manufacturing and packaging instructions

b. Validation protocols and reports

c. Certificate of Analysis

d. Laboratory control records

55 / 60

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

a. Airlock

b. Quarantine zone

c. Clean area

d. Production line

56 / 60

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

a. Class I recall

b. Class III recall

c. All of the above

d. Class II recall

57 / 60

The main objective of quality assurance is?

a. Inspection of quality of product

b. Proof of fitness of product

c. Quality conformance

d. Customer satisfaction

58 / 60

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

a. To maximize profit margins

b. To ensure compliance with regulatory standard

c. To maximize production efficiency

d. To minimize manufacturing costs

59 / 60

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

a. Process validation

b. Change control validation

c. Cleaning validation

d. Analytical method validation

60 / 60

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

a. Submit a CAPA Request

b. Investigate and Plan

c. Closure

d. Implement and Verify

Your score is

The average score is 91%

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Contrôle De Qualité II Test

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