Qualification and Validation

What is the purpose of the qualification process in the pharmaceutical industry?

• To save money on regulatory compliance

• To ensure that employees are properly trained

• To speed up the production process

• To ensure that equipment, facilities, and processes are suitable for their intended use and meet regulatory requirements.

What are the key steps involved in the qualification of Pharma Equipment?

• A, B, C, D

• Testing, Analysis, Review, Approval

• DQ, IQ, OQ, PQ

• Cleaning, Maintenance, Repair, Replacement

How does qualification differ from validation in the pharmaceutical industry?

• Qualification demonstrates suitability, while validation establishes consistency

• Qualification is only done once, while validation is ongoing

• Qualification and validation are the same thing

• Qualification is only for equipment, while validation is for processes

What are some common challenges faced during the qualification and validation process?

• Stagnant regulatory standards

• Unlimited resources and budget

• Clearly defined requirements

• Some common challenges include resource constraints, lack of clear requirements, and changing regulatory standards.

What are the consequences of not meeting qualification and validation standards in the pharmaceutical industry?

• Enhanced customer satisfaction

• Product recalls, regulatory fines, loss of reputation, and potential harm to patients

• Improved product quality

• Increased sales and profits

How can continuous improvement be integrated into the qualification and validation process?

• Regularly reviewing and updating procedures, incorporating feedback from stakeholders, and implementing best practices

• Ignoring feedback and stakeholder input

• Implementing outdated procedures

• Not making any changes to the process

In PQ of Tablet Machine , what will you do

• Equipment utilities compressed air/vaccum etc checking

• Equipment PLC and controls

• Machine speed and Cam track -Upper and Lower Punch Test

• Compress Dummy and check parameters H,F,DT, Stcking, Picking

In Fluid bed Dryer qualification what is important

• Power  Steam  Compressed air   Air/ water r

• rEquipment Safety Features:  Barrier guard, alarm, emergency stop button, interlock whigh temperature alarm device

• Component specifications:  Motor speed,Calibration of Ammeter and guage

• A and B

• All of the above

Dry powder Mixers should be qualified for

• Maximum and Minimum loading capacity

• Maximum and Minimum Time

• Maximum and Minimum Speed

• All of the above