Contrôle De Qualité II Test

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1 / 60

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

a. Quarantine zone

b. Production line

c. Airlock

d. Clean area

2 / 60

The principle of laboratory results-out of specification is?

a. to validate of analytical method

b. to re-testing of the sample

c. to release the certification of analysis

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

3 / 60

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

a. To monitor employee performance

b. To evaluate the efficiency of manufacturing processes

c. To assess the effectiveness of marketing campaigns

d. To ensure the accuracy and reliability of test results

4 / 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

5 / 60

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

a. microbiological assay

b. Titration, Spectrophotometry, Chromatographie (HPLC)

c. Character, Identification

d. Melting point, Solubility

6 / 60

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

a. Internal audit

b. Internal audit or self-inspection

c. Self-inspection

d. External audit

7 / 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

8 / 60

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

a. La sécurité

b. L’information administrative

c. L’efficacité

d. La qualité

9 / 60

OOS is abbreviation used for?

a. Out of storage

b. Out of specification

c. Out of sterility

d. Out of stock

10 / 60

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

a. បញ្ជាក់ពីគុណភាពថ្នាំនៃឡូត៍ដែលបានផលិត

b. រកភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត

c. តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម!ដើម្បើដំណើរការម៉ាស៊ីនផលិត

d. បញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត

11 / 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

12 / 60

Receiving of wet Products is complaint associated with?

a. Packaging Complaint

b. Product complaint

c. Physical properties complaint

d. Delivery complaint

13 / 60

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

a. Submit a CAPA Request

b. Implement and Verify

c. Investigate and Plan

d. Closure

14 / 60

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

a. To determine the optimal production capacity

b. To confirm the accuracy of financial forecasts

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

d. To assess the market demand for a product

15 / 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. Titration and Identification

b. The cylinder-plate (or plate) assay

c. Spectrophotometry and Chromatographie (HPLC)

d. The turbidimetric (or tube) assay

16 / 60

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

a. Internal

b. Verbal

c. External

d. Written

17 / 60

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

a. Class II recall

b. Class III recall

c. Class I recall

d. All of the above

18 / 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. Quality control is depending on production and quality assurance department.

c. Production department is depending on QA operating procedure.

d. QC is responsible of approval SOP.

19 / 60

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

a. Maximize shareholder value

b. Increase production speed

c. Continuous improvement

d. Reduce employee turnover

20 / 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

21 / 60

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

a. Sales and marketing

b. Human resources (HR)

c. Quality assurance (QA)

d. Research and development (RD)

22 / 60

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

a. External

b. Internal

c. Written

d. Verbal

23 / 60

What is QA?

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

b. It is a corrective tool

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

d. Process of identifying defects

24 / 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. All complaints must be reviewed according to written procedures

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

25 / 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. Accepted complaint

d. None

26 / 60

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

a. Complaint samples

b. Retention sample

c. Complaint record files

d. Batch records

27 / 60

Any deviation occur can reported by?

a. All departments

b. Quality Assurance

c. Production

d. Quality Control

28 / 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

29 / 60

Any deviation occur can reported by?

a. Production

b. Quality Control

c. All departments

d. Quality Assurance

30 / 60

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

a. To increase sales revenue

b. To promote advertising campaigns

c. To identify and rectify quality issues

d. To evaluate employee performance

31 / 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

32 / 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

33 / 60

The main objective of quality assurance is?

a. Customer satisfaction

b. Inspection of quality of product

c. Proof of fitness of product

d. Quality conformance

34 / 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

35 / 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. The turbidimetric (or tube) assay

c. Spectrophotometry and Chromatographie (HPLC)

d. The cylinder-plate (or plate) assay

36 / 60

Responsibility of a complaint lies with?

a. All of above

b. Administration Unit head

c. Quality assurance head

d. Production head

37 / 60

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

a. Non confirmed complaint

b. Confirmed complaint

c. Tampered complaint

d. Counterfeit complaint

38 / 60

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

a. Product complaint

b. Service complaint

c. Physical properties complaint

d. Packaging complaint

39 / 60

The procedures of quality control laboratory are included, except?

a. Management of reference substances

b. Retest dating of raw materials

c. Calibration policies for laboratory instruments

d. Deviation reporting approval

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

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

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

41 / 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

42 / 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. None of these

c. B is correct

d. A is correct

43 / 60

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

a. Finished product monitoring

b. Factory visits

c. None of these

d. Warehouse monitoring

44 / 60

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

a. QC

b. Production

c. Purchase

d. QA

45 / 60

The entry in Batch Manufacturing Record is done by?

a. Quality control department

b. Quality assurance department

c. Warehouse department

d. Production department

46 / 60

La bonne pratique de fabrication (BPF) est appliquée ?

a. laboratoire biologie et production de médicament

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

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

d. laboratoire de contrôle qualité du médicament

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

48 / 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

49 / 60

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

a. Production scheduling

b. Inventory management

c. Statistical process control

d. High-performance liquid chromatography (HPLC)

50 / 60

Which of the following is an example of QA?

a. Product testing

b. Process of mixing method

c. Purchasing of raw materials

d. Verification

51 / 60

Issues related to foreign matter in a product is?

a. Packaging complaint

b. Product complaint

c. Service complaint

d. Physical properties complaint

52 / 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. Process design qualification (PDQ)

d. Operation qualification (OQ)

53 / 60

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

a. To calculate financial ratios

b. To quality control limits

c. To define employee work schedules

d. To outline manufacturing processes

54 / 60

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

a. Quality control

b. Quality management

c. Quality improvement

d. Quality assessment

55 / 60

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

a. QC

b. QA

c. Purchase

d. Production

56 / 60

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

a. Equipment qualification

b. Cleaning validation

c. Analytical method validation

d. Process validation

57 / 60

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

a. To minimize manufacturing costs

b. To ensure compliance with regulatory standard

c. To maximize production efficiency

d. To maximize profit margins

58 / 60

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

a. Cross-contamination

b. Impurity contamination

c. In-process contamination

d. Contamination test

59 / 60

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

a. Quality sampling

b. Quality assurance

c. Quality system

d. Quality control

60 / 60

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

a. Scatter diagram

b. Complaint trend analysis

c. Control chart

d. Check sheet

Your score is

The average score is 61%

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Contrôle De Qualité II Test

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និស្សិតអាចប្រាប់មកកាន់ពួកយើងបានដើម្បីកែកំហុស ឬអំពីបញ្ហាដោយអចេតនាណាមួយដែលកើតមានកំឡុងពេលធ្វើតេស្ត