Rosebys Interview Questions and Answers

The impact of set values of parameters on product quality

• Set values of parameters can have a direct impact on product quality

• If the set values do not affect the product quality, it is considered non-impactful

• Examples of parameters that can affect product quality include temperature, pressure, and time

• Proper calibration and monitoring of parameters can ensure consistent product quality

The mean of Direct impact and No impact systems is undefined.

• Direct impact and No impact systems are not comparable in terms of impact.

• Direct impact systems have a significant impact on the organization or process, while No impact systems have no impact.

• Therefore, calculating the mean of these two types of systems is not meaningful.

• It is important to evaluate the impact of each system separately and make decisions accordingly.

Risk assessment is the process of identifying, analyzing and evaluating potential risks to an organization or project.

• Helps in identifying potential risks and their impact

• Enables prioritization of risks based on their severity

• Assists in developing strategies to mitigate or manage risks

• Provides a framework for decision-making and resource allocation

• Examples: financial risk assessment, cybersecurity risk assessment, project risk assessment

Clean rooms in sterile areas are maintained to prevent contamination and ensure product safety.

• Clean rooms are classified based on the number of particles per cubic meter of air.

• Sterile areas typically have clean rooms classified as ISO 5 or ISO 7.

• Clean rooms have controlled air flow, temperature, and humidity.

• Personnel entering clean rooms must wear appropriate protective clothing.

• Equipment and materials used in clean rooms must be sterilized or sanitized.

• Examples of sterile...read more

Flows of Validation refers to the process of verifying and confirming the accuracy and integrity of data or information.

• Flows of Validation involve checking data for errors, inconsistencies, and completeness.

• Validation can be done through various methods such as data sampling, cross-referencing, and data reconciliation.

• Examples of validation processes include validating financial transactions, validating user input in software applications, and validating scientific research ...read more

Yes, sterile EU GMP guidelines define four grades of cleanrooms: A, B, C, and D.

• Sterile EU GMP guidelines define four grades of cleanrooms: A, B, C, and D.

• Grade A is the most stringent and is used for critical operations such as aseptic filling.

• Grade D is the least stringent and is used for activities such as gowning and material transfer.

• Each grade has specific requirements for air cleanliness, particle counts, and microbial counts.

• The classification of a cleanroom is determ...read more