Alembic Apprentice Trainee Interview Questions and Answers

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 activ...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 stab...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

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-d...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 ...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

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 quali...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...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...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.