10+ Ajanta Pharma Senior Officer Interview Questions and Answers

Process validation is the process of ensuring that a process consistently produces a product that meets its specifications.

• Process validation involves establishing documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

• The sampling step involves selecting a representative sample of the product and testing it to ensure that it meets the predetermined specifications.

• The sampling plan s...read more

Hold time study is a method used to determine the amount of time a process or task can be paused without negatively impacting its outcome.

• Hold time study is conducted to identify the maximum allowable pause time for a process or task.

• It helps in determining the impact of interruptions or delays on the overall efficiency and quality of the process.

• Hold time study involves observing and measuring the time taken for a process to resume after a pause.

• It is often used in manufactu...read more

The question is related to the effects of temperature and relative humidity on exertion.

• Exertion can be affected by both temperature and relative humidity.

• High temperature and humidity can increase the strain on the body during physical activity.

• Excessive exertion in extreme temperature and humidity conditions can lead to heat-related illnesses.

• Proper hydration and rest breaks are important to manage exertion in such conditions.

The significant change in stability refers to a noticeable shift in the balance or strength of a system or organization.

• Changes in leadership can lead to a significant change in stability within an organization.

• Economic fluctuations can also impact the stability of a financial system.

• Technological advancements may disrupt the stability of traditional industries.

• Natural disasters can cause a sudden change in stability within a community or region.

S1, S2, and S3 in dissolution test refer to the stages of the test where different parameters are measured.

• S1 is the stage where the sample is introduced into the dissolution medium.

• S2 is the stage where the dissolution process takes place and the drug is released from the dosage form.

• S3 is the stage where the concentration of the drug in the dissolution medium is measured over time.

• These stages help in determining the rate and extent of drug release from the dosage form.

RPN stands for Reverse Polish Notation, a mathematical notation where operators follow their operands.

• RPN is used in calculators and programming languages like Forth and PostScript.

• In RPN, instead of using parentheses to indicate order of operations, the order is determined by the position of the operator.

• For example, in RPN, the expression 3 + 4 * 5 would be written as 3 4 5 * +.

RPN is calculated using a postfix notation where operators come after the operands.

• RPN stands for Reverse Polish Notation

• Operators come after the operands in RPN

• RPN is evaluated using a stack data structure

• Example: 3 4 + 5 * = 35

• Example: 10 5 / 2 * = 4

BU stands for Business Unit.

• BU refers to a distinct division or department within an organization.

• It is responsible for a specific product, service, or market segment.

• BU operates independently and has its own goals, strategies, and resources.

• Examples of BUs include sales, marketing, finance, and operations.

Guidelines for QMS documentation

• Document all processes and procedures

• Ensure documents are easily accessible and up-to-date

• Include clear instructions and responsibilities

• Maintain version control and document history

• Ensure documents are reviewed and approved by relevant personnel

• Ensure documents are aligned with organizational goals and objectives

RRT in HPLC stands for Relative Retention Time, which is a measure of how long a particular compound takes to elute from the column relative to a reference compound.

• RRT is calculated by dividing the retention time of the compound of interest by the retention time of the reference compound.

• It is used to compare the elution times of different compounds in an HPLC chromatogram.

• RRT helps in identifying and characterizing compounds based on their elution behavior.

• For example, if a...read more

Packaging validation is the process of ensuring that the packaging of a product is safe, effective, and meets regulatory requirements.

• Packaging validation involves testing the packaging materials and design to ensure they can withstand the stresses of transportation and storage.

• It also involves testing the packaging to ensure it does not interact with the product in a way that could compromise its safety or efficacy.

• Packaging validation is important in industries such as phar...read more

Dissolution test is a method used to determine how quickly a drug substance dissolves in a solution.

• It is an important test in pharmaceutical industry to ensure the effectiveness of a drug.

• The test involves placing a dosage form in a solution and measuring the amount of drug that dissolves over time.

• Results of the test help determine the bioavailability of the drug and its release rate.

• Different regulatory agencies have specific guidelines for conducting dissolution tests.

• Exa...read more