QUALITY CONTROL

JOB STARTER PACKAGE

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Welcome to the QC Job Starter Package!

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Enroll in our Quality Control Job Starter Package for comprehensive training in QC methodologies, tools, and best practices. Gain hands-on experience and boost your career prospects in the competitive job market. Let us guide you toward success in the dynamic field of quality assurance.

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This package is ideal for students and professionals seeking to enhance their skills and knowledge in quality control. Whether you’re new to the field or looking to advance your career, this package is tailored to meet your needs. If you’re aiming for success in QC roles across various industries, this is your pathway to proficiency and career growth.

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Pre-Assessment Quiz

You reached the maximum time limit for this mock test.

Quality Control Pre-Assessment Quiz

Time: 60 minutes

Questions: 55

The number of attempts remaining is 1

1 / 55

In UV-Visible Spectroscopy, what leads to electronic transitions in molecules?

a) Absorption of microwaves

b) Absorption of UV or visible light

c) Absorption of X-rays

d) Absorption of infrared light

2 / 55

What apparatus is commonly used for the disintegration test of suppositories?

a) Wire mesh basket

b) B.P. disintegration test apparatus

c) Breaking test instrument

d) Analytical balance (calibrated)

3 / 55

What is the primary goal of Root Cause Analysis (RCA)?

a) Addressing symptoms and consequences

b) Identifying the root causes of problems

c) Achieving immediate relief from problems

d) Improving organizational communication

4 / 55

How can the density of aerosols be determined effectively?

a) Using a hydrometer.

b) Using a pycnometer.

c) Using gas chromatography.

d) Using infrared spectrophotometry.

5 / 55

What is the primary concern associated with particulate matter in parenteral products administered via the intravenous (IV) route?

a) Color variation

b) Packaging defects

c) Particle contamination

d) Temperature instability

6 / 55

What is the vessel of choice when employing the hydrometer technique for density evaluation?

a) Glass pressure tube.

b) Stainless steel container.

c) Plastic bottle.

d) Aluminium can.

7 / 55

What is the purpose of a Pareto Chart?

a) To represent data in a pie chart format

b) To visually identify key contributors for improvement efforts

c) To calculate cumulative percentages

d) To display a line chart only

8 / 55

Which of the following is NOT a common tonicity-adjusting agent for ophthalmic solutions?

a) Sodium chloride

b) Sodium nitrate

c) Dextrose

d) Ethanol

9 / 55

How can histograms be used to analyze data across different groups or time periods?

a) By counting the total number of data points.

b) By plotting geographical locations.

c) By comparing the distribution of data points within each group or time perio

d) By analyzing the average value.

10 / 55

What is the purpose of spray vaccines in pharmaceuticals?

a) Disinfect surfaces

b) Deliver medication directly to the lungs

c) Provide targeted treatment orally

d) Offer an alternative to traditional injections

11 / 55

What is the purpose of the assay of active ingredients in suppositories?

a) Assessing odor

b) Determining melting range

c) Evaluating drug release

d) Measuring active ingredient content

12 / 55

What does the R chart monitor in a process?

a) Central tendency

b) Variability

c) Standard deviation

d) Historical data or statistical formulas

13 / 55

What is the purpose of the hydrolytic resistance test for glass containers?

a) To evaluate the resistane of glass to water penetration and orrosion

b) To ensure glass ontainers are free from partiulate matter

c) To determine the ability of glass ontainers to withstand sudden hanges in temperature

d) To verify that glass ontainers do not ontain harmful levels of arseni

14 / 55

What are the main features of Descriptive statistics?

a) Summarizing, organizing, and presenting

b) Drawing conclusions about a population

c) Estimating population parameters

d) Making inferences about a sample

15 / 55

What is the purpose of the weight uniformity test for suppositories?

a) Assessing odor

b) Determining melting range

c) Evaluating mechanical strength

d) Measuring uniformity

16 / 55

What does Process Capability Index with Centering (Cpk) take into account that Process Capability Index (Cp) does not?

a) The within-subgroup standard deviation

b) The process range

c) The specification range

d) The overall process standard deviation

17 / 55

How is the leakage rate of Pharmaceutical Aerosols calculated?

a) By measuring the weight change of a container before and after vertical storage

b) By subjecting valves to their design limits

c) By evaluating inner lining defects in coated and uncoated containers

d) By calculating 365 into 24 divided by T into (W1 - W2)

18 / 55

What is the primary objective of quality control in capsule manufacturing?

a) To enhance medication taste

b) To ensure long-term efficacy

c) To improve shelf life

d) To maintain patient safety

19 / 55

Which chromatographic technique is based on the separation of volatile compounds using a gaseous medium?

a) High-Performance Liquid Chromatography (HPLC)

b) Thin Layer Chromatography (TLC)

c) Gas Chromatography (GC)

d) Paper Chromatography

20 / 55

In creating a Pareto Chart, what is the first step?

a) Order the categories from highest to lowest frequency/percentage

b) Collect data on potential causes

c) Identify the problem to analyze

d) Categorize the data

21 / 55

What is the purpose of the identification test for capsules?

a) To determine the size of capsules

b) To confirm the presence of the active pharmaceutical ingredient (API)

c) To test for disintegration time

d) To assess the color uniformity of capsules

22 / 55

What is the phenomenon observed in cocoa butter suppositories during storage, and how can it be prevented?

a) Discoloration

b) Disintegration

c) Bloom formation

d) Odor

23 / 55

What is the aim of Continuous Process Monitoring?

a) To identify and address underlying factors contributing to process variability

b) To ensure consistent tablet quality

c) To calculate process capability indices

d) To determine the sample size based on statistical considerations

24 / 55

In a manufacturing company's production line, where are the potential bottlenecks identified?

a) Inspection and assembly steps

b) Quality check and packaging steps

c) Raw material receiving and shipping steps

d) Cutting and assembly steps

25 / 55

What is the primary challenge associated with the direct transfer method of sterility testing?

a) Requirement for specialized equipment

b) Potential errors due to the need for precise technique

c) Lengthy incubation period

d) Limited availability of culture media

26 / 55

What is the purpose of Packaging Compatibility Testing for plastic containers?

a) To evaluate the bioompatibility of plasti materials

b) To determine the transpareny and olor onsisteny of ontainers

c) To examine the sealing integrity of losures

d) To assess the ompatibility with other pakaging omponents

27 / 55

Which of the following is a factor considered for process adjustments in tablet manufacturing optimization?

a) Tablet dissolution rate

b) Raw material variability

c) Blending time

d) Environmental conditions

28 / 55

What role does capsule customization play in pharmaceutical formulation?

a) Reducing drug efficacy

b) Enhancing drug delivery

c) Decreasing patient compliance

d) Lowering manufacturing costs

29 / 55

What does process capability assess in a manufacturing process?

a) Product consistency

b) Equipment reliability

c) Raw material quality

d) Market demand

30 / 55

What is the purpose of the hydrolytic resistance test for glass containers?

a) To assess light transmission

b) To evaluate water penetration and corrosion

c) To measure arsenic levels

d) To determine resistance to moisture

31 / 55

What does the range represent in a dataset?

a) The average of the squared differences

b) The square root of the variance

c) The number of standard deviations

d) The difference between max and min

32 / 55

Why is optimization important in pharmaceutical manufacturing?

a) To minimize the need for continuous monitoring

b) To consistently produce high-quality products

c) To ensure compliance with regulatory standards

d) To reduce the frequency of process adjustments

33 / 55

What is the objective of drug content determination in pharmaceutical quality control for ointments?

a) To ensure specified API concentration

b) To evaluate consistency

c) To assess pH value

d) To measure spreadability

34 / 55

In a pharmaceutical company using a control chart to monitor filling consistency, what do data points outside the control limits indicate?

a) The filling machine needs maintenance.

b) The volume of medication filled is consistent.

c) Potential special cause variation requiring investigation and corrective action.

d) The filling machine is malfunctioning.

35 / 55

What are the key regulatory requirements for Root Cause Analysis (RCA) in pharmaceuticals?

a) Avoiding documentation

b) Timely conduct of RCA

c) Ineffective RCA processes

d) Untrained personnel

36 / 55

What is the next step after a Change Request is approved?

a) Change Review

b) Validation

c) Execution

d) Planning and Preparation

37 / 55

How is the texture and consistency of ointments evaluated?

a) By visual inspection

b) By measuring pH values

c) By tasting the product

d) By touching the product

38 / 55

How is the foam stability of pharmaceutical aerosols evaluated?

a) By noting the time required for a complete collapse of foam

b) By noting the time required for a given mass to penetrate the foam

c) By noting the time required for a rod inserted into the foam to fall

d) All of the above

39 / 55

Why is leakage testing conducted for Pharmaceutical Aerosols?

a) To evaluate the delivery rate per actuation

b) To ensure the absence of defective containers

c) To assess defects in valves and spray patterns

d) To verify the weight of filled containers

40 / 55

What is the purpose of the Leakage Test for collapsible tubes?

a) To assess lacquer curing

b) To evaluate the flexibility of tube material

c) To ensure the integrity of tube seal and prevent leakage

d) To test the self-sealability of tube closures

41 / 55

What benefit does SPC offer in regulated industries?

a) Improves customer satisfaction.

b) Reduces production costs.

c) Demonstrates compliance with regulations.

d) Enhances brand image.

42 / 55

What characterizes major changes in the pharmaceutical industry?

a) Routine modifications with minimal impact on product quality

b) Alterations requiring streamlined procedures

c) Modifications with substantial impact on product quality, safety, or compliance

d) Structural changes impacting organizational culture

43 / 55

What is the third element of the ADKAR Model used in change management systems?

a) Awareness

b) Desire

c) Knowledge

d) Ability

44 / 55

What is the primary purpose of the sterility test in the quality control process of parenteral manufacturing?

a) To determine the color of the sample

b) To identify potential quality issues

c) To ensure the absence of viable microorganisms

d) To assess the stability of the product

45 / 55

Which test ensures that glass containers are free from any particulate matter that could contaminate pharmaceutical products?

a) Hydrolyti Resistane Test

b) Water Attak Test

c) Powdered Glass Test

d) Annealing Test

46 / 55

Which method of leaker testing involves subjecting the container to negative pressure or vacuum?

a) Visual Inspection

b) Bubble Test

c) Dye Tests

d) Vacuum Ionization Test

47 / 55

What is the expectation of the FDA regarding Root Cause Analysis (RCA) in pharmaceuticals?

a) Conducting investigations without documentation

b) Implementing ineffective CAPA plans

c) Utilizing systematic approaches and appropriate tools

d) Maintaining opaque records of RCA activities

48 / 55

What is the premise of Pareto analysis in decision-making?

a) 80% of problems can be traced to 80% of causes

b) 80% of problems can be traced to 20% of causes

c) 20% of problems can be traced to 80% of causes

d) 20% of problems can be traced to 20% of causes

49 / 55

How are Change Requests assessed during the process?

a) Based on urgency and importance

b) Based on alignment with strategic objectives

c) Based on feasibility and resource availability

d) Based on potential impact on business operations

50 / 55

What is Null Hypothesis (H 0)?

a) There is a significant difference

b) There is no significant difference

c) Probability of observing a test statistic

d) Rejecting the null hypothesis

51 / 55

What defines organizational changes within pharmaceutical companies?

a) Changes to drug formulations or delivery systems

b) Modifications to supply chain processes

c) Updates or revisions to standard operating procedures (SOPs)

d) Structural changes, reorganizations, or mergers and acquisitions

52 / 55

How should deviations from established procedures be addressed in suppository manufacturing?

a) Thoroughly investigated and addressed through CAPAs

b) Ignored as they do not significantly impact production

c) Reported only to production managers

d) Hidden from regulatory authorities

53 / 55

What is the primary purpose of root cause analysis in pharmaceutical manufacturing?

a) To identify potential variations in tablet characteristics

b) To ensure compliance with regulatory standards

c) To optimize the tablet manufacturing process

d) To address underlying factors contributing to process variability

54 / 55

What is the primary objective of quality control in capsule manufacturing?

a) To enhance the flavor of capsules

b) To understand the importance of capsule manufacturing

c) To ensure patient safety and medication efficacy

d) To decrease the production cost

55 / 55

What is the main emphasis of the assay and impurities test in ophthalmic pharmaceuticals?

a) To assess potency

b) To identify any component present

c) To distinguish between closely related structures

d) To quantify related substances

Your score is

PRE-ASSESSMENT QUIZ

You reached the maximum time limit for this mock test.

Quality Control Pre-Assessment Quiz

Time: 60 minutes

Questions: 55

The number of attempts remaining is 1

1 / 55

What is the purpose of toxicity testing for pharmaceutical aerosols?

a) To evaluate the irritation potential of the aerosol

b) To determine the chilling effect of propellants

c) To assess the rise in temperature on spraying of aerosols

d) All of the above

2 / 55

How is the Pareto principle applied in Pareto Analysis?

a) By ranking causes in ascending order

b) By random selection

c) By ignoring significant factors

d) By prioritizing based on importance

3 / 55

Which international standard promotes a quality management approach to pharmaceutical manufacturing?

a) ISO 9001

b) 21 CFR Part 820

c) ICH Q10

d) ISO 13485

4 / 55

What is the principle of UV-Visible Spectroscopy based upon?

a) Measurement of mass-to-charge ratio

b) Absorption of UV-visible light by molecules

c) Separation of compounds based on differential migration

d) Measurement of the absorption of infrared radiation

5 / 55

What is the phenomenon observed in cocoa butter suppositories during storage, and how can it be prevented?

a) Hardening

b) Disintegration

c) Bloom formation

d) Discoloration

6 / 55

What is the Pareto Principle also known as?

a) 70/30 rule

b) 90/10 rule

c) 80/20 rule

d) 60/40 rule

7 / 55

What is a critical consideration in quality control testing for strip or blister packaging?

a) Resistance to temperature changes

b) Moisture barrier properties

c) Seal strength

d) Visual inspection for scratches or peeling

8 / 55

What is the purpose of the assay of active ingredients in suppositories?

a) Assessing odor

b) Determining melting range

c) Evaluating drug release

d) Measuring active ingredient content

9 / 55

What is the evaluation method for Aerosol Valve Discharge Rate?

a) Weighing the aerosol before and after discharge

b) Measuring the spray pattern on a rotating disc

c) Determining the dosage received by the patient

d) Observing foam stability over time

10 / 55

What is the purpose of viscosity enhancers in ophthalmic solutions?

a) Decrease viscosity

b) Shorten retention time

c) Increase viscosity

d) Enhance clarity

11 / 55

What is one of the challenges in Statistical Process Control (SPC) implementation mentioned in the text?

a) Poor-quality data

b) Lack of regulatory guidelines

c) Excessive workforce

d) Overabundance of data

12 / 55

What do analytical techniques aim to identify, quantify, and analyze in the pharmaceutical industry?

a) Mechanical properties

b) Biological processes

c) Chemical composition

d) Electrical conductivity

13 / 55

In the context of Tablet Manufacturing, what is the significance of Root Cause Analysis?

a) To assess the potential capability of the compression process

b) To calculate the Process Capability Index (Cp)

c) To identify and address the underlying factors contributing to process variability and deviations from target values

d) To ensure consistent tablet quality through continuous monitoring and adjustment of critical process parameters (CPP)

14 / 55

What is essential for achieving high Cp and Cpk values in tablet manufacturing?

a) Increasing process variability

b) Reducing process control

c) Continuous monitoring and adjustment

d) Ignoring critical process parameters

15 / 55

What marks the beginning of the Change Management process?

a) Change Approval

b) Change Identification

c) Change Evaluation

d) Change Prioritization

16 / 55

Why is determining pressure variation between different patch containers important in vapour pressure evaluation?

a) To ensure proper functioning of the pressure gauge.

b) To check for the presence of air within the dispense headspace.

c) To verify the accuracy of the water bath test gauge.

d) To measure the density of the aerosol.

17 / 55

What is the primary purpose of the appearance test for capsules?

a) To qualitatively describe the physical characteristics of capsules

b) To accurately discern and distinguish between the intended API and closely related compounds

c) To confirm the presence of the active pharmaceutical ingredient (API)

d) To detect and quantify impurities

18 / 55

Which type of aerosols provides localized therapy for skin disorders, pain relief, or nasal congestion?

a) Oral Aerosols

b) Spray Vaccines

c) Surface Disinfectants

d) Topical Aerosols

19 / 55

Which type of suppository is intended for insertion into the vagina?

a) Rectal suppositories

b) Conical suppositories

c) Bullet-shaped suppositories

d) Vaginal suppositories

20 / 55

What is the principle underlying Nuclear Magnetic Resonance (N M R) spectroscopy?

a) Electronic spin

b) Nuclear spin

c) Vibrational spin

d) Orbital spin

21 / 55

Why is identifying systemic issues crucial in RCA within the pharmaceutical industry?

a) To ignore broader challenges

b) To apply temporary fixes

c) To enhance overall performance

d) To increase inefficiencies

22 / 55

Which of the following is a type of eye preparation for prolonged contact and sustained release of medication?

a) Eye drops

b) Eye patches

c) Gels

d) Intraocular lenses

23 / 55

Which of the following is NOT true regarding interpreting a scatter plot?

a) A downward slope suggests a negative correlation

b) Clusters or patterns in data points should be ignored

c) Correlation does not imply causation

d) Trendline can represent the central tendency of data points

24 / 55

What is a key component of a Change Control Form?

a) Change Review

b) Proposed Action Plan

c) Risk Assessment Matrices

d) Change Status Tracking

25 / 55

What is the aim of Random Sampling?

a) Representation from all subgroups

b) Accessibility

c) Bias reduction

d) Convenience

26 / 55

How does SPC contribute to QMS?

a) Provides real-time data for process monitoring.

b) Defines quality objectives.

c) Manages customer relationships.

d) Conducts audits.

27 / 55

What is the principle of UV-Visible Spectroscopy based upon?

a) Measurement of mass-to-charge ratio

b) Absorption of UV-Visible light by molecules

c) Separation of compounds in a liquid medium

d) Ionization of molecules

28 / 55

What is the purpose of Headspace Oxygen Analysis in quality control procedures for ampoules?

a) To detet raks or impurities

b) To measure oxygen levels in the headspae

c) To examine seal integrity

d) To evaluate the physial properties of ampoules

29 / 55

What is Inferential statistics concerned with?

a) Describing main features of a dataset

b) Organizing data in a meaningful way

c) Drawing conclusions about a population

d) Summarizing data

30 / 55

How does process capability impact product quality in pharmaceutical manufacturing?

a) It has no impact on product quality

b) It ensures consistent drug quality

c) It increases product variability

d) It reduces production efficiency

31 / 55

What is the primary purpose of calculating process capability indices (Cp, CpK) in the context of tablet hardness inconsistency during compression?

a) To visualize coating thickness distribution

b) To assess the potential and actual capability of the compression process

c) To identify patterns of variation and potential outliers

d) To evaluate the impact of raw material variability on the manufacturing process

32 / 55

What is the purpose of conducting the pH determination test for ointments and creams?

a) To assess the rate of absorption

b) To evaluate spreadability

c) To measure consistency

d) To determine acidity or alkalinity

33 / 55

Why is compliance with regulatory requirements essential for pharmaceutical Change Management?

a) To maximize profitability

b) To ensure product quality and safety

c) To minimize research and development costs

d) To expedite market access

34 / 55

What physical characteristics are assessed in the weight uniformity test?

a) Color

b) Shape

c) Odor

d) Dimensions

35 / 55

What is the third element of the ADKAR Model used in change management systems?

a) Awareness

b) Desire

c) Knowledge

d) Ability

36 / 55

What do the bars on a Pareto Chart represent?

a) Individual categories and their magnitude

b) Cumulative percentage

c) Frequency of each category

d) Sequential addition of categories

37 / 55

Which regulatory authorities mandate stringent quality standards for pharmaceutical products?

a) FDA

b) WHO

c) ISO

d) USP

38 / 55

What does Change Management involve in the pharmaceutical industry?

a) Planning, implementation, and monitoring

b) Research, development, and marketing

c) Distribution, sales, and advertising

d) Production, packaging, and labeling

39 / 55

What is the primary purpose of Quality Control (QC)?

a) Reducing marketing expenses

b) Maximizing profits

c) Ensuring products meet predefined standards and customer expectations

d) Expanding market share

40 / 55

What characterizes major changes in the pharmaceutical industry?

a) Routine modifications with minimal impact on product quality

b) Alterations requiring streamlined procedures

c) Modifications with substantial impact on product quality, safety, or compliance

d) Structural changes impacting organizational culture

41 / 55

What is the primary objective of understanding quality control in the manufacturing of parenteral products?

a) To gain knowledge of essential quality control tests

b) To identify potential quality issues

c) To ensure rapid absorption of drugs into the bloodstream

d) To administer medications to patients who are unable to swallow

42 / 55

What is the primary purpose of the sterility test in the quality control process of parenteral manufacturing?

a) To determine the color of the sample

b) To identify potential quality issues

c) To ensure the absence of viable microorganisms

d) To assess the stability of the product

43 / 55

What does the presence of gel clot indicate in the LAL Test?

a) Absence of endotoxin

b) Presence of endotoxin

c) Presence of viable microorganisms

d) Absence of microbial growth

44 / 55

What is the purpose of the Consolidate Gains and Produce More Change step in Kotter’s 8-Step Change Model?

a) To create a sense of urgency

b) To reinforce change by institutionalizing new behaviors, systems, and processes

c) To generate short-term wins

d) To empower broad-based action

45 / 55

Which element of the ADKAR Model involves recognizing and rewarding desired behaviors and outcomes?

a) Reinforcement

b) Desire

c) Knowledge

d) Awareness

46 / 55

What are pyrogens primarily derived from in parenteral products?

a) Gram-positive bacteria

b) Viruses

c) Fungi

d) Gram-negative bacteria

47 / 55

What type of data does a variable check sheet record?

a) Completion of specific tasks

b) Specific observations

c) Numerical data such as measurements

d) Presence or absence of features

48 / 55

What is the primary objective of evaluating the coating applied to metallic tins for packaging?

a) To enhance product appearance

b) To maintain product integrity

c) To prevent chemical reactions

d) To facilitate recycling

49 / 55

Which instrument is commonly used for the disintegration test of suppositories?

a) B.P. disintegration test apparatus

b) Analytical balance (calibrated)

c) Breaking test instrument

d) Suppository dialysis cell

50 / 55

Which evaluation is necessary to protect metallic tins against corrosion and maintain product integrity?

a) Visual inspection for uniformity

b) Measurement of inner dimensions

c) Adherence to regulatory standards

d) Evaluation of coating quality

51 / 55

Which property of paper and board is assessed through tests like tensile strength and tear resistance?

a) Moisture content

b) Density

c) Mechanical strength

d) Flexibility

52 / 55

How is the rate of release of medicament from ointments evaluated?

a) By measuring spread area

b) By assessing drug content

c) By observing zones of inhibition

d) By conducting pH determination

53 / 55

How should deviations from established procedures be addressed in suppository manufacturing?

a) Thoroughly investigated and addressed through CAPAs

b) Ignored as they do not significantly impact production

c) Reported only to production managers

d) Hidden from regulatory authorities

54 / 55

How is the R f value (retention factor) calculated in T L C?

a) Distance traveled by the compound

b) Distance traveled by the mobile phase

c) Total distance traveled by the mobile phase

d) Total distance traveled by the compound

55 / 55

What is the primary purpose of Statistical Process Control (SPC)?

a) To identify and eliminate sources of variation in a process

b) To ensure constant innovation

c) To maximize production efficiency

d) To increase product diversity

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QUALITY CONTROL

JOB STARTER PACKAGE

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Welcome to the QC Job Starter Package!

Why to Enroll?

Who Should Buy this Package?

Original Price for $70/- Offer Price $25/-

Original Price for ₹5000/- Offer Price ₹999/-

Pre-Assessment Quiz

PRE-ASSESSMENT QUIZ

Explore Full Package Now!

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Query Form

Original Price for $70/-
Offer Price $25/-

Original Price for ₹5000/-
Offer Price ₹999/-