INDIABULLS PHARMACEUTICALS Senior Quality Assurance and Quality Control Officer Interview Questions and Answers

TLC stands for Thin Layer Chromatography, a technique used to separate and analyze mixtures of chemicals.

• TLC involves a stationary phase (thin layer of adsorbent material) and a mobile phase (solvent).

• The sample mixture is spotted on the TLC plate and the plate is placed in a developing chamber with the mobile phase.

• Different components of the mixture move at different rates on the plate, allowing for separation and id...read more

Disintegration is the breakdown of a solid dosage form into smaller particles, while dissolution is the process by which a solid substance dissolves in a liquid.

• Disintegration is a physical process, while dissolution is a chemical process.

• Disintegration involves the breaking down of a tablet or capsule into smaller pieces, while dissolution involves the solubilization of the active ingredient.

• Disintegration testing is ...read more

Data integrity guidelines ensure accuracy, consistency, and reliability of data throughout its lifecycle.

• Implement access controls to restrict data modification to authorized personnel.

• Use validation checks to ensure data entered meets predefined criteria (e.g., format, range).

• Regularly back up data to prevent loss and ensure recovery in case of corruption.

• Conduct audits and reviews to identify and rectify discrepancie...read more

Change control is a process used to manage and document changes to a system or process.

• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more

Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.

• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more

Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.

• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more

Yes, I am interested in Microbiology analytical review.

• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more

Purified water specification refers to the set of requirements and standards that purified water must meet.

• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more

The purified water specification for microbial quality assurance.

• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more

Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.

• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more