10+ Kapston Services Interview Questions and Answers

Stratified sample analysis helps ensure representative sampling, while content uniformity test ensures consistency of active ingredients in a sample.

• Stratified sample analysis involves dividing a population into subgroups based on certain characteristics before sampling.

• Content uniformity test is used to ensure that the amount of active ingredient in each dosage unit is consistent.

• Both techniques are important in quality control to ensure the reliability and accuracy of test ...read more

Disintegration test is a test performed on tablets to determine the time it takes for a tablet to break down into smaller particles.

• Disintegration test helps to ensure that the tablet will disintegrate properly in the body for effective drug release.

• The criteria for disintegration test vary depending on the type of tablet and the intended use.

• Common criteria include the time it takes for the tablet to disintegrate into particles smaller than a certain size, usually specified ...read more

Typically, three batches are performed in the pharmaceutical industry before the commercial batch.

• Typically, the first batch is the pilot batch, followed by the validation batch, and then the commercial batch.

• The pilot batch is used to test the manufacturing process on a small scale before scaling up for commercial production.

• The validation batch is used to ensure that the manufacturing process consistently produces a product that meets quality standards.

• Once the pilot and va...read more

Parameters used in dry granulation and reasons for its use.

• Parameters include particle size, shape, and density of the powder material.

• Reasons for dry granulation include avoiding use of solvents, improving flow properties, and enhancing compressibility.

• Examples of dry granulation methods are slugging and roller compaction.

There are three main types of stability tests in pharma: accelerated stability testing, long-term stability testing, and intermediate stability testing.

• Accelerated stability testing: conducted at higher temperatures to predict the stability of a drug over a shorter period of time.

• Long-term stability testing: conducted at recommended storage conditions to assess the stability of a drug over its entire shelf life.

• Intermediate stability testing: conducted at intermediate conditi...read more

Parameters used in tablet manufacturing include formulation, compression force, tablet hardness, disintegration time, and friability.

• Formulation - ingredients used in the tablet

• Compression force - pressure applied during tablet compression

• Tablet hardness - resistance to breaking

• Disintegration time - time taken for tablet to break down in the body

• Friability - tendency of tablet to break or crumble

ER/IR dissolution acceptance criteria refers to the standards used to determine the dissolution rate of extended-release and immediate-release pharmaceutical products.

• ER/IR dissolution acceptance criteria are set by regulatory agencies to ensure the effectiveness and safety of the drug.

• For example, the FDA may require that a certain percentage of the active ingredient is released within a specific time frame for the drug to be considered acceptable.

• Acceptance criteria may var...read more

Excipients are inactive substances added to a drug to serve as a carrier or aid in the manufacturing process.

• There are several types of excipients including fillers, binders, disintegrants, lubricants, and preservatives.

• Fillers add bulk to the formulation and ensure accurate dosing.

• Binders help hold the active ingredients together in a tablet or capsule.

• Disintegrants promote the breakup of the tablet or capsule in the digestive tract for absorption.

• Lubricants prevent ingredie...read more

Coating in tablets refers to a layer applied to the tablet for various purposes such as taste masking, protection, or controlled release of the drug.

• Coating helps in masking the taste of the drug, making it easier for patients to consume.

• It provides protection to the drug from environmental factors such as moisture and light.

• Coating can also be used for controlled release of the drug, ensuring a sustained effect over time.

• Parameters for coating include thickness, uniformity, ...read more

CPP stands for Critical Process Parameters and CQA stands for Critical Quality Attributes of tablets.

• CPP are the key variables that must be controlled to ensure the tablet manufacturing process is successful.

• CQA are the characteristics that are critical to the quality of the tablet and must be monitored and controlled.

• Examples of CPP include mixing time, compression force, and drying temperature.

• Examples of CQA include tablet hardness, dissolution rate, and content uniformity...read more

HPLC, KF, and Dissolution are common techniques used in pharmaceutical analysis.

• HPLC stands for High Performance Liquid Chromatography, used for separating, identifying, and quantifying components in a mixture.

• KF refers to Karl Fischer titration, a method for measuring water content in a sample.

• Dissolution testing is used to determine how quickly a drug dissolves in a solution, simulating its behavior in the body.

• All three techniques are essential in pharmaceutical quality co...read more

Exhibit batches are used for stability studies and regulatory submissions, while PPQ batches are used for process validation.

• Exhibit batches are manufactured for stability studies and regulatory submissions.

• PPQ (Process Performance Qualification) batches are manufactured for process validation.

• Exhibit batches are typically larger in size compared to PPQ batches.

• Exhibit batches are used to demonstrate the product's stability over time.

• PPQ batches are used to validate the manuf...read more

Process Validation is the documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes.

• Process Validation is a requirement in industries such as pharmaceuticals, medical devices, and food production.

• It involves establishing documented evidence that a process is capable of consistently producing a product that meets its specifications.

• Validation activities include process design, qualification, and ongoing m...read more

Cleaning validation is the process of ensuring that a cleaning procedure effectively removes residues from equipment used in the manufacturing process.

• Cleaning validation is essential in industries such as pharmaceuticals, food and beverage, and cosmetics.

• It involves establishing documented evidence that the cleaning process consistently removes residues to predetermined levels.

• Validation typically includes developing a cleaning procedure, conducting cleaning trials, analyzin...read more

Film coating is a process in which a thin layer of coating material is applied to a solid dosage form to improve appearance, taste, and stability.

• Film coating helps protect the drug from moisture, light, and air

• It can also mask the taste of the drug to improve patient compliance

• Examples of film-coated tablets include Advil and Tylenol

LOD stands for Level of Detail. It refers to the amount of detail present in a model or visualization.

• LOD is commonly used in computer graphics to optimize performance by displaying less detail when objects are far away.

• It can also refer to the level of detail in data analysis, where different levels of granularity are used for different purposes.

• For example, in a 3D video game, LOD may be used to switch between high-detail and low-detail models based on distance from the cam...read more

Tablet manufacturing process involves mixing active pharmaceutical ingredients with excipients, compressing into tablets, and coating if necessary.

• Active pharmaceutical ingredients (APIs) and excipients are mixed together in a blender.

• The mixture is then compressed into tablets using a tablet press.

• Tablets may undergo coating for taste masking or controlled release.

• Quality control measures are implemented throughout the process to ensure consistency and efficacy.

• Examples of e...read more