Apotex Research Senior Executive Interview Questions and Answers

Forced degradation study is a process used to determine the stability of a drug substance or product under various stress conditions.

• Forced degradation studies involve subjecting the drug to conditions such as heat, light, humidity, and acid/base hydrolysis to simulate potential degradation pathways.

• The purpose of these studies is to identify degradation products, determine degradation pathways, and establish the stabi...read more

Validation parameters are criteria used to ensure data input meets specified requirements.

• Validation parameters can include data type, length, format, range, and presence.

• For example, a validation parameter for a phone number field may require 10 digits and no special characters.

• Validation parameters help prevent errors and ensure data integrity.

• They are commonly used in form fields and database entries.

Validations in executive roles can face challenges due to lack of data accuracy, timeliness, and stakeholder alignment.

• Data accuracy issues can lead to incorrect decisions being made.

• Timeliness of data can impact the speed at which decisions can be made.

• Lack of stakeholder alignment can result in conflicting priorities and goals.

• Inconsistent validation processes across departments can lead to discrepancies in data inte

A validation plan outlines the process for ensuring that a product or system meets specified requirements and standards.

• Defines the objectives and scope of validation activities

• Identifies the resources, responsibilities, and timelines for validation

• Specifies the methods and procedures for testing and evaluating the product or system

• Includes criteria for acceptance and rejection of validation results

Calibration of HPLC is a process of adjusting the settings of the High Performance Liquid Chromatography system to ensure accurate and reliable results.

• Calibration involves checking and adjusting the flow rate, detector sensitivity, and column efficiency.

• Regular calibration helps maintain the accuracy and precision of the HPLC system.

• Calibration standards are used to verify the performance of the system.

• Documentation o...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Ensures data is accurate and reliable

• Prevents unauthorized access or changes

• Maintained through data validation and verification processes