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. Written

c. Internal

d. External

2 / 60

Quality Control involved in pharmaceutical manufacturing process from?

a. Sampling of starting materials to batch release for sale

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 for quality control of starting materials to quality control of finished product

3 / 60

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

a. Complaint record files

b. Complaint samples

c. Retention sample

d. Batch records

4 / 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. Spectrophotometry and Chromatographie (HPLC)

c. The cylinder-plate (or plate) assay

d. Titration and Identification

5 / 60

The procedures of quality control laboratory are included, except?

a. Managing of analytical reagents

b. Creation of certificate of analysis

c. Process validation

d. Laboratory waste management

6 / 60

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

a. QA

b. Production

c. Purchase

d. QC

7 / 60

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

a. Document control

b. Cost reduction strategies

c. Training programs

d. Risk management

8 / 60

What is the reason for initiating a CAPA?

a. To deviate from a Work Instruction

b. To eliminate a nonconformity

c. To rework a product

d. To make a risk assessment

9 / 60

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

a. QA

b. Purchase

c. Production

d. QC

10 / 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 by production staff after product manufacturing process

c. Deviation report is written when receiving of raw materials

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

11 / 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. Confirmed complaint

d. Counterfeit complaint

12 / 60

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

a. QC is an integral part of Production

b. Production and QC are independent to each other

c. Production is an integral part of QC

d. QC may or may not depend on Production

13 / 60

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

a. Quality Control

b. All departments

c. Quality Assurance

d. Production

14 / 60

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

a. To maximize production efficiency

b. To maximize profit margins

c. To minimize manufacturing costs

d. To ensure compliance with regulatory standard

15 / 60

The main objective of quality assurance is?

a. Inspection of quality of product

b. Customer satisfaction

c. Quality conformance

d. Proof of fitness of product

16 / 60

The procedures of quality control laboratory are included, except?

a. Self-inspection

b. Retention samples laboratory

c. Stability study protocols

d. Laboratory result out of specification report

17 / 60

The following statements are true, except?

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

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

c. All complaints must be reviewed according to written procedures

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

18 / 60

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

a. Contamination test

b. In-process contamination

c. Cross-contamination

d. Impurity contamination

19 / 60

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

a. Good manufacturing practices

b. General manufacturing principles

c. Generic manufacturing procedures

d. Global manufacturing protocols

20 / 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. Quality assurance check

d. In-process control

21 / 60

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

a. Self-inspection

b. Internal audit or self-inspection

c. External audit

d. Internal audit

22 / 60

Two general techniques for antibiotics microbial assay are?

a. Qualitative and Quantitative

b. Titration and Identification

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

d. Spectrophotometry and Chromatographie (HPLC)

23 / 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

24 / 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 define employee work schedules

d. To quality control limits

25 / 60

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

a. To determine the optimal production capacity

b. To assess the market demand for a product

c. To confirm the accuracy of financial forecasts

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

26 / 60

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

a. Verbal

b. External

c. Internal

d. Written

27 / 60

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

a. Received goods

b. Recalled goods

c. Returned goods

d. Expired goods

28 / 60

Issues related to foreign matter in a product is?

a. Physical properties complaint

b. Product complaint

c. Packaging complaint

d. Service complaint

29 / 60

The correct sequence for handling complaint is?

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

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

30 / 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

31 / 60

Choose the correct sentence?

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

b. QC is responsible of approval SOP.

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

d. Production department is depending on QA operating procedure.

32 / 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 III recall

d. Class II recall

33 / 60

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

a. Quality management

b. Quality control

c. Quality improvement

d. Quality assessment

34 / 60

Receiving of wet Products is complaint associated with?

a. Delivery complaint

b. Packaging Complaint

c. Product complaint

d. Physical properties complaint

35 / 60

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

a. Warehouse monitoring

b. Finished product monitoring

c. Factory visits

d. None of these

36 / 60

OOS is abbreviation used for?

a. Out of stock

b. Out of specification

c. Out of storage

d. Out of sterility

37 / 60

Choose the correct sentence?

a. Only quality assurance can report of deviation

b. deviation is reported by QC after every batch analysis

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

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

38 / 60

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

a. Equipment qualification

b. Analytical method validation

c. Process validation

d. Cleaning validation

39 / 60

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

a. L’efficacité

b. La qualité

c. La sécurité

d. L’information administrative

40 / 60

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

a. Statistical process control

b. High-performance liquid chromatography (HPLC)

c. Production scheduling

d. Inventory management

41 / 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. Degradation

c. Cross-contamination

d. In-process control

42 / 60

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

a. Character, Identification

b. Titration, Spectrophotometry, Chromatographie (HPLC)

c. microbiological assay

d. Melting point, Solubility

43 / 60

Any deviation occur can reported by?

a. Quality Control

b. Production

c. Quality Assurance

d. All departments

44 / 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. Non confirmed complaint

c. None

d. Accepted complaint

45 / 60

What is QA?

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

b. It is a corrective tool

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

d. Process of identifying defects

46 / 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. Quarantine zone

b. Clean area

c. Airlock

d. Production line

47 / 60

Which phrase is not correct about deviation report system?

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

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

48 / 60

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

a. Returning of goods

b. Recalling of goods

c. Restoring of goods

d. Reporting of goods

49 / 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. Titration and Identification

b. Spectrophotometry and Chromatographie (HPLC)

c. The turbidimetric (or tube) assay

d. The cylinder-plate (or plate) assay

50 / 60

Any deviation occur can reported by?

a. All departments

b. Quality Control

c. Production

d. Quality Assurance

51 / 60

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

a. Returned goods

b. Recalled goods

c. Expired goods

d. Received goods

52 / 60

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

a. Managing good manufacturing practices

b. Assuring the quality and traceability of finished product

c. Managing of manufacturing plan

d. Assuring the quality of raw materials

53 / 60

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

a. one of qualitative or quantitative

b. Both qualitative and quantitative

c. Qualitative

d. Quantitative

54 / 60

Responsibility of a complaint lies with?

a. Quality assurance head

b. All of above

c. Production head

d. Administration Unit head

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. Human resources (HR)

d. Sales and marketing

56 / 60

The entry in Batch Manufacturing Record is done by?

a. Warehouse department

b. Quality assurance department

c. Quality control department

d. Production department

57 / 60

Which of the following is an example of QA?

a. Verification

b. Process of mixing method

c. Product testing

d. Purchasing of raw materials

58 / 60

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

a. 3 working days

b. 5 working days

c. No limit timeframe

d. 7 working days

59 / 60

A Preventive Action is put in place to?

a. Eliminate a potential cause of a nonconformity

b. Identify a nonconformity

c. Make you work on a device longer

d. Identify the reason a nonconformity occurred

60 / 60

Quality Assurance involved in pharmaceutical manufacturing process from?

a. Purchase of starting materials to batch release for sale

b. Sampling of starting materials to batch release for sale

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

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

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Contrôle De Qualité II Test

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