Steril Gene Life Sciences Interview Questions and Answers

In the process of manufacturing oral solids, various steps are carried out to ensure quality and efficacy.

• Raw material testing and selection

• Granulation or blending of active ingredients and excipients

• Compression or encapsulation of the mixture into tablets or capsules

• Coating of tablets for protection and ease of swallowing

• Packaging and labeling of the final product

• Quality control testing at different stages

• Documentation and record-keeping

Analytical method development involves creating and optimizing methods to accurately analyze samples.

• Identifying the purpose of the analysis

• Selecting appropriate analytical techniques

• Optimizing parameters for accurate results

• Validating the method for reliability

• Documenting the method for reproducibility

Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose.

• Validation ensures accuracy, precision, specificity, and linearity of an analytical method.

• Parameters validated include accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness.

• Validation is typically done through experiments, comparison with a reference method, or by using standards.

• Validation protocols ...read more

QMS stands for Quality Management System, a set of policies, processes, and procedures required for planning and execution in the core business area of an organization.

• QMS ensures that products and services meet customer requirements and quality standards.

• It involves quality planning, quality control, quality assurance, and quality improvement.

• QMS helps in achieving consistency and improvement in operations.

• ISO 9001 is a popular standard for QMS implementation.

• Documentation, ...read more

Cleaning validation process ensures that cleaning procedures effectively remove residues from equipment and surfaces.

• Cleaning validation is a documented process to demonstrate that cleaning procedures are effective in removing residues.

• It involves establishing acceptance criteria, selecting appropriate sampling methods, and performing analytical testing.

• The process includes cleaning verification, which confirms that cleaning procedures are followed correctly.

• Cleaning validati...read more

Buffers are temporary storage areas in a computer's memory used to hold data while it is being transferred or processed.

• Buffers help prevent data loss or corruption during data transfer.

• They are commonly used in networking to manage data flow between devices.

• Buffers can also be found in audio and video editing software to temporarily store data before processing.

Compression is the reduction in size of a file or data to save storage space or transmission time.

• Compression is used to reduce the size of files or data to save storage space or transmission time.

• There are two types of compression: lossless compression (reduces file size without losing any data) and lossy compression (reduces file size by removing some data).

• Examples of compression algorithms include ZIP, JPEG, and MP3.

• Compression is commonly used in multimedia files, docume...read more