Gland Pharma EHS Executive Interview Questions and Answers

CPP parameters refer to Critical Process Parameters which have a significant impact on Critical Quality Attributes (CQA) in manufacturing processes.

• CPP parameters are specific process variables that must be controlled within a certain range to ensure product quality.

• Examples of CPP parameters include temperature, pressure, flow rate, and mixing speed.

• The impact of CPP parameters on CQA can be seen in the final product ...read more

The annual report submission procedure for USFDA approved products involves compiling data on product performance, safety, and compliance with regulations.

• Compile data on product performance, safety, and compliance with USFDA regulations

• Submit the annual report to the USFDA within the specified deadline

• Include information on any changes in manufacturing processes or product labeling

• Ensure all data submitted is accurate

Lyophilization is a technique used to remove water from a product by freeze-drying it.

• Lyophilization involves freezing the product and then subjecting it to a vacuum to remove the frozen water through sublimation.

• This technique is commonly used in the pharmaceutical industry to preserve drugs and vaccines.

• Lyophilization helps to extend the shelf life of products and maintain their stability.

• It is also used in the food ...read more

Trouble shooting during cycle development

• Identify the problem or issue

• Analyze the root cause

• Develop a plan to resolve the problem

• Implement the plan

• Monitor and evaluate the results

• Make necessary adjustments if needed