NextGen Interview Questions and Answers

Deviation is a departure from approved procedures or specifications. It can be planned or unplanned.

• Planned deviation is a pre-approved change in a process or procedure. For example, changing the manufacturing process of a drug to improve its quality.

• Unplanned deviation is an unexpected event that occurs during the manufacturing process. For example, a machine breakdown that causes a delay in production.

• Both types of deviation must be documented and investigated to determine ...read more

Guidelines for QMS, change control, stability, artwork etc.

• QMS guidelines should cover all aspects of quality management, including documentation, training, and audits.

• Change control guidelines should outline the process for making changes to products or processes, including documentation and approval requirements.

• Stability guidelines should cover the testing and monitoring of product stability over time, including storage conditions and testing intervals.

• Artwork guidelines s...read more

Artwork should be checked for accuracy and compliance with regulations.

• Verify all text is accurate and matches the approved copy

• Ensure all required elements are present and in the correct location

• Check for proper color usage and consistency

• Confirm compliance with regulatory requirements

• Perform a final proofread for any errors or inconsistencies

The life cycle of change control involves planning, implementing, reviewing, and approving changes to a system or process.

• Planning: Identify the need for change and create a plan.

• Implementation: Make the necessary changes and document them.

• Review: Evaluate the effectiveness of the changes and identify any issues.

• Approval: Obtain approval from stakeholders before implementing the changes.

• Examples: Updating software, changing manufacturing processes, revising policies and proce...read more

QMS in Pharma refers to the set of policies, procedures, and processes that ensure the quality of pharmaceutical products.

• QMS includes quality control, quality assurance, and quality improvement.

• It ensures compliance with regulatory requirements and industry standards.

• QMS involves documentation, training, and continuous monitoring.

• Examples of QMS tools include SOPs, CAPAs, and audits.

• QMS is essential for ensuring patient safety and product efficacy.

An air handling unit is a device used to regulate and circulate air as part of a heating, ventilation, and air conditioning (HVAC) system.

• AHUs are typically located in mechanical rooms or on rooftops of buildings.

• They consist of components such as fans, filters, heating and cooling coils, dampers, and humidifiers.

• AHUs help maintain indoor air quality by controlling temperature, humidity, and air circulation.

• Examples of AHU manufacturers include Trane, Carrier, and Daikin.