Entero Healthcare Solutions Purchase Manager Interview Questions and Answers

Qualification of machine in packing and flow process

• Qualification of machine in packing involves testing and validating the machine's performance and capabilities

• Flow process includes steps like installation, operational testing, performance testing, and documentation

• In my previous company, we followed a qualification protocol that included IQ, OQ, and PQ stages

• We also conducted periodic requalification to ensure the m

Recovered amount in accuracy parameter validations is calculated by comparing the actual amount with the expected amount.

• Calculate the difference between the actual amount and the expected amount

• Verify if the recovered amount falls within an acceptable range of error

• Adjust the recovered amount based on any discrepancies found

• Document the process and findings for future reference

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