Contrôle qualité-Pr.Thearith-85Q
1) Which following is not a component of quality assurance in a pharmaceutical plant?
Quality control
Quality management
Quality assessment
Quality improvement
2) What is the main objective of quality assurance in a pharmaceutical plant?
To maximize production efficiency
To minimize manufacturing costs
To ensure compliance with regulatory standard
To maximize profit margins
3) What is the purpose of conducting internal audits in a pharmaceutical plant?
To increase sales revenue
To evaluate employee performance
To identify and rectify quality issues
To promote advertising campaigns
4) What does the abbreviation GMP stand for in the context of quality assurance in the pharmaceutical industry?
Generic manufacturing procedures
General manufacturing principles
Global manufacturing protocols
Good manufacturing practices
5) Which of the following is not an essential element of a quality management system in a pharmaceutical plant?
Document control
Training programs
Risk management
Cost reduction strategies
6) What is the purpose of conducting process validation in pharmaceutical manufacturing?
To optimize production speed
To minimize raw material costs
To improve marketing strategies
To ensure product efficacy
7) Which department is typically responsible for implementing and maintaining a quality management system in a pharmaceutical plant?
Research and development (RD)
Human resources (HR)
Sales and marketing
Quality assurance (QA)
8) What is the role of standard operating procedures (SOPs) in quality assurance?
To define employee work schedules
To quality control limits
To outline manufacturing processes
To calculate financial ratios
9) Which of following is a key principle of quality assurance in the pharmaceutical industry?
Maximize shareholder value
Increase production speed
Reduce employee turnover
Continuous improvement
10) What is the purpose of conducting stability studies in pharmaceutical manufacturing?
To assess the effectiveness of advertising campaigns
To determine employee productivity
To evaluate the shelf life of a product
To measure customer satisfaction
11) Which of the following is an example of an analytical testing method used in quality assurance of pharmaceutical products?
Inventory management
Statistical process control
High-performance liquid chromatography (HPLC)
Production scheduling
12) What is the primary purpose of conducting a validation study in the pharmaceutical industry?
To assess the market demand for a product
To determine the optimal production capacity
To confirm the accuracy of financial forecasts
To establish documented evidence that a process consistently product meeting its predetermined specifications
13) Which QMS tool helps in understanding the cause-and-effect relationship between various factors influencing a problem?
Scatter diagram
Control chart
Fishbone diagram
Histogram
14) Which QMS tool is used to track and analyze customer complaints and feedback?
Control chart
Check sheet
Scatter diagram
Complaint trend analysis
15) Which type of validation is conducted during the initial installation of a new piece of equipment?
Process validation
Cleaning validation
Analytical method validation
Equipment qualification
16) What is the purpose of analytical method validation in the pharmaceutical industry?
To assess the effectiveness of marketing campaigns
To evaluate the efficiency of manufacturing processes
To monitor employee performance
To ensure the accuracy and reliability of test results
17) Which phase of process validation involves demonstrating that a process can consistently produce a desired product under normal operating conditions?
Process design qualification (PDQ)
Installation qualification (IQ)
Operation qualification (OQ)
Performance qualification (PQ)
18) Which type of validation is conducted when changes are made to an existing validation process or equipment?
Process validation
Cleaning validation
Analytical method validation
Change control validation
19) The following statements are true, except?
All complaints must be reviewed according to written procedures
Recall Operations can only be performed during the normal working day
Recall operations must be able to be initiated promptly at any time
Written recall procedures are necessary as long as everyone knows what they are doing
20) Responsibility of a complaint lies with?
Production head
Quality assurance head
Administration Unit head
All of above
21) Primary document to be reviewed in technical investigation stage of complaint handling is?
Complaint record files
Batch records
Complaint samples
Retention sample
22) 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?
Non confirmed complaint
Confirmed complaint
Accepted complaint
None
23) Issues related to labeling or coding of batch details, secondary packaging material problems comes under the complaint?
Service complaint
Physical properties complaint
Packaging complaint
Product complaint
24) Issues related to foreign matter in a product is?
Service complaint
Physical properties complaint
Packaging complaint
Product complaint
25) Receiving of wet Products is complaint associated with?
Product complaint
Delivery complaint
Packaging Complaint
Physical properties complaint
26) If a complaint is received from Production, Quality Control, Warehouse, Sales Department, the source is said to be?
External
Internal
Verbal
Written
27) If a complaint is received from customers, doctors, paramedics, clinics, hospitals, drugstores etc. The source of complaint is said to be?
External
Internal
Verbal
Written
28) If a complaint is received by email, the source of complaint is said to be?
External
Internal
Verbal
Written
29) The correct sequence for handling complaint is?
Receiving complaint, corrective actions, Investigation, feedback to customer, Trend analysis of QC result
Investigation, Receiving complaint, corrective actions, Trend analysis of QC result, feedback to customer
Receiving complaint, Trend analysis of QC result, Investigation, feedback to customer, corrective actions
Receiving complaint, feedback to customer, Trend analysis of QC result, corrective actions, Investigation
30) OOS is abbreviation used for?
Out of stock
Out of specification
Out of storage
Out of sterility
31) When complaint & retained sample are in compliance with specification, Complaint sample is OOS due to misuse/ mishandling, it is?
Confirmed complaint
Non confirmed complaint
Tampered complaint
Counterfeit complaint
32) When only complaint sample is OOS, with no definite reason, like packaging material is different etc. It is referred as?
Confirmed complaint
Non confirmed complaint
Tampered complaint
Counterfeit complaint
33) Bulk/ finished product when sent back to Manufacturer, distributor, importer is known as?
Returned goods
Recalled goods
Expired goods
Received goods
34) Bulk/ finished product when retrieval or withdrawal from market is known as?
Returned goods
Recalled goods
Expired goods
Received goods
35) Withdrawing or removing the product from distribution network as of quality issues/ adverse drug reactions is known as?
Returning of goods
Restoring of goods
Recalling of goods
Reporting of goods
36) When there is probability by a product to cause serious health issues, it is?
Class II recall
Class I recall
Class III recall
All of the above
37) When there is probability that Product may cause temporary or remote Adverse health issues it is?
Class III recall
Class II recall
Class I recall
Class IV recall
38) Serious adverse reactions of product that cause serious consequences to health after receipt of complaint must be recall within?
3 working days
5 working days
7 working days
No limit timeframe
39) Product may cause temporary or remote adverse health issues after receipt of complaint must be recall within?
3 working days
5 working days
7 working days
No limit timeframe
40) An audit performed by an organization on itself is called a?
Internal audit
External audit
Self-inspection
Internal audit or self-inspection
41) 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?
Laboratory control records
Validation protocols and reports
Manufacturing and packaging instructions
Certificate of Analysis
42) 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?
Laboratory control records
Validation protocols and reports
Manufacturing and packaging instructions
Certificate of Analysis
43) What is the reason for initiating a CAPA?
To deviate from a Work Instruction
To rework a product
To eliminate a nonconformity
To make a risk assessment
44) Evaluating the Root Cause of a nonconformance happens in which stage of a CAPA?
Implement and Verify
Closure
Submit a CAPA Request
Investigate and Plan
45) A Preventive Action is put in place to?
Identify a nonconformity
Make you work on a device longer
Eliminate a potential cause of a nonconformity
Identify the reason a nonconformity occurred
46) La bonne pratique de fabrication (BPF) est appliquée ?
à la fois à la production et au contrôle de la qualité des médicaments
Laboratoire biologie et production de médicament
Laboratoire de contrôle qualité du médicament
Laboratoire de toxicologie, laboratoires de l’industrie chimique et laboratoires de recherche de chimi
47) La Module 3 du dossier CTD (ou ACTD) est décrit des informations concernent ?
La sécurité
L’efficacité
La qualité
L’information administrative
48) Définition de la spécification ?
Liste d'analyses avec les références à des procédures analytiques et les critères d'acceptation appropriées
Capacité de la méthode de permettre une évaluation non équivoque de l'analyte en présence de composants qui sont susceptibles d'être présents
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
Ensemble des activités destinées à maintenir ou à rétablir un bien dans un état ou dans des conditions données de sûreté de fonctionnement
49) In process control (Contrôle en cours de la fabrication ធ្វើដើម្បី?
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���កភាពបំបែកគ្រាប់ថ្នាំមុនពេលផលិត
���ញ្ជាក់ពីភាពត្រឹមត្រូវទំងន់គ្រាប់ថ្នាំមុនពេលផលិត
���េស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម ដើម្បីដំណើរការម៉ាស៊ីនផលិត
50) The activity (potency) of antibiotics can be demonstrated by their inhibitory effect on microorganisms. The method can be used for analysis is?
Microbiological assay
Titration, Spectrophotometry, Chromatographie (HPLC)
Melting point, Solubility
Character, Identification
51) Two general techniques for antibiotics microbial assay are?
The cylinder-plate (or plate) assay and the turbidimetric (or tube) assay
Spectrophotometry and Chromatographie (HPLC)
Qualitative and Quantitative
Titration and Identification
52) The assay depends on diffusion of the antibiotic from a vertical through a solidified agar layer in a Petri dish is the principle of?
The cylinder-plate (or plate) assay
The turbidimetric (or tube) assay
Spectrophotometry and Chromatographie (HPLC)
Titration and Identification
53) 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?
The cylinder-plate (or plate) assay
The turbidimetric (or tube) assay
Spectrophotometry and Chromatographie (HPLC)
Titration and Identification
54) Quality Control involved in pharmaceutical manufacturing process from?
Purchase of starting materials to batch release for sale
Sampling of starting materials to batch release for sale
Sampling for quality control of starting materials to quality control of finished product
Purchase of starting materials to sampling for quality control of finished product
55) Quality Assurance involved in pharmaceutical manufacturing process from?
Purchase of starting materials to batch release for sale
Sampling of starting materials to batch release for sale
Sampling for quality control of starting materials to quality control of finished product
Purchase of starting materials to sampling for quality control of finished product
56) Which of the following department holds responsibilities for quality monitoring or audit?
QC
QA
Production
Purchase
57) To approve or reject the starting materials, packaging materials, intermediate, bulk and finished product is the responsibility of which department?
QC
QA
Production
Purchase
58) The finished products containing active ingredients should comply with ………………. Composition of the marketing authorization.?
Qualitative
Quantitative
Both qualitative and quantitative
One of qualitative or quantitative
59) Which of the following options is correct regarding Production and QC?
QC is an integral part of Production
Production is an integral part of QC
Production and QC are independent to each other
QC may or may not depend on Production
60) What is QA?
It is the measurement of degree to which a product satisfies the need
Any systematic process used to ensure quality in the process
Process of identifying defects
It is a corrective tool
61) Which of the following is an example of QA?
Verification
Product testing
Process of mixing method
Purchasing of raw materials
62) The entry in Batch Manufacturing Record is done by?
Quality control department
Quality assurance department
Warehouse department
Production department
63) 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 is correct
B is correct
Both A and B
None of these
64) Which one is part of quality management focused on providing confidence that quality requirement will be fulfilled?
Quality system
Quality control
Quality assurance
Quality sampling
65) The main objective of quality assurance is?
Proof of fitness of product
Inspection of quality of product
Quality conformance
Customer satisfaction
66) Following this statement are general objectives of quality assurance, except?
Managing good manufacturing practices
Managing of manufacturing plan
Assuring the quality of raw materials
Assuring the quality and traceability of finished product
67) Which of the following is NOT covered under Finished product quality assurance?
Finished product monitoring
Factory visits
Warehouse monitoring
None of these
68) 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?
Clean area
Production line
Quarantine zone
Airlock
69) 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?
Batch number
Batch records
Batch analysis
Common technical document (CTD)
70) An area with defined environmental control of particulate and microbial contamination, is?
Clean area
Production line
Quarantine zone
Airlock
71) 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?
Contamination
Cross-contamination
In-process control
Degradation
72) Contamination of a starting material, intermediate product or finished product with another starting material or product during production is?
Impurity contamination
Cross-contamination
In-process contamination
Contamination test
73) 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?
Contamination correction
Validation process
In-process control
Quality assurance check
74) 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?
QC
QA
Production
Purchase
75) Choose incorrect sentence?
All department/unit need to write down the SOP procedure and follow the SOP approval.
QA is responsible of approval SOP and no need to write their own SOP
After SOP created, QA must verify work processing with SOP before approval.After SOP created, QA must verify work processing with SOP before approval.
Quality control procedure is under responsibility of quality control department.
76) Choose the correct sentence?
QC is responsible of approval SOP.
Production department is depending on QA operating procedure.
SOP has instructions on how to write a formal operating procedure for your systems which your people can follow everyday.
Quality control is depending on production and quality assurance department.
77) Which phrase is described about deviation report system?
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.
Deviation report is written when receiving of raw materials
Deviation report is written by production staff after product manufacturing process
When product conform to specification, the deviation must be reported
78) Which phrase is not correct about deviation report system?
It is a regulatory requirement to capture all sorts of deviations to maintain the continuous improvement to your processes and systems
It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes.
It describes the management responsibilities of initiating deviation and initiatives to be taken on corrective and preventative actions.
Before the deviation is reported, the corrective and preventative actions have to be completed.
79) Choose the correct sentence?
Deviation is reported by QC after every batch analysis
Production will write deviation report after raw materials are mixed.
Any department in pharmaceutical system can write deviation report after problem happened.
Only quality assurance can report of deviation
80) The procedures of quality control laboratory are included, except?
Retest dating of raw materials
Calibration policies for laboratory instruments
Management of reference substances
Deviation reporting approval
81) The procedures of quality control laboratory are included, except?
Creation of certificate of analysis
Managing of analytical reagents
Laboratory waste management
Process validation
82) The procedures of quality control laboratory are included, except?
Retention samples laboratory
Laboratory result out of specification report
Stability study protocols
Self-inspection
83) The principle of laboratory results-out of specification is?
To re-testing of the sample
To release the certification of analysis
To report the non-conformity of the test parameters
To validate of analytical method
84) The laboratory results-out of specification (OOS) is reported by?
Quality Control
Quality Assurance
Production
All departments
85) Any deviation occur can reported by?
Quality Control
Quality Assurance
Production
All departments
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