Parenteral Drugs 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

I am known for my ability to inspire and motivate others to achieve their goals.

• I have a natural talent for identifying people's strengths and helping them to develop those strengths.

• I am a skilled communicator and can effectively convey my ideas and vision to others.

• I have a positive attitude and am able to maintain a sense of optimism even in challenging situations.

• I lead by example and am always willing to roll up m...read more

Batch charging processing refers to the process of charging multiple items at once.

• Batch charging processing is commonly used in industries such as manufacturing and logistics.

• It involves charging multiple items simultaneously, which can save time and increase efficiency.

• Examples of batch charging processing include charging multiple electric vehicles at a charging station or charging multiple batteries in a warehouse.

• ...read more

Yes, I am familiar with CAPA process and validation deviation process.

• CAPA (Corrective and Preventive Action) process is a quality management system used to identify, investigate, and resolve quality issues.

• Validation deviation process is used to document and investigate any deviations from the validated process or procedure.

• Both processes are important in ensuring quality and compliance in various industries, includin...read more

Equipment cleaning involves thorough disinfection and sterilization to prevent contamination.

• Use appropriate cleaning agents and disinfectants recommended for the specific equipment

• Follow manufacturer's instructions for cleaning and maintenance

• Regularly inspect equipment for any signs of wear or damage

• Implement proper storage practices to prevent contamination

• Train staff on proper cleaning procedures and protocols

Contamination can be classified into three main types: chemical, biological, and physical.

• Chemical contamination involves the presence of harmful chemicals in a substance or environment.

• Biological contamination refers to the presence of harmful microorganisms such as bacteria, viruses, or fungi.

• Physical contamination occurs when foreign objects like glass, metal, or plastic are present in a substance.

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