Podcast
Questions and Answers
What is the main focus of Lecture 4: GMP; Documentation and Validation?
What is the main focus of Lecture 4: GMP; Documentation and Validation?
- Validation principles (correct)
- Standard operating procedures
- Premises and Personnel Documentation
- Calibration and Verification
Which ILO involves recommending the correct validation or qualification approaches for specific processes?
Which ILO involves recommending the correct validation or qualification approaches for specific processes?
- Communicating clearly by verbal means
- Recalling and specifying used terminology
- Evaluating process from industrial case studies (correct)
- Classifying the types of documentation
What is the key difference between validation and qualification according to the lecture outline?
What is the key difference between validation and qualification according to the lecture outline?
- Calibration and Verification
- Verification principles
- Validation principles (correct)
- Change Control
Which part of the pharmaceutical industry does the course mainly aim to improve quality systems within?
Which part of the pharmaceutical industry does the course mainly aim to improve quality systems within?
What is the primary goal of Change Control in the context of GMP and QMS?
What is the primary goal of Change Control in the context of GMP and QMS?
Which ILO involves recalling and specifying terminology used in quality systems within the pharmaceutical industry?
Which ILO involves recalling and specifying terminology used in quality systems within the pharmaceutical industry?
What are the three main levels of classification for areas in a pharmaceutical facility based on protection?
What are the three main levels of classification for areas in a pharmaceutical facility based on protection?
Which of the following are typical HVAC system parameters that should be qualified for a pharmaceutical facility?
Which of the following are typical HVAC system parameters that should be qualified for a pharmaceutical facility?
What must documentation in a pharmaceutical facility be approved, signed and dated by?
What must documentation in a pharmaceutical facility be approved, signed and dated by?
What does the term 'specifications' refer to in a pharmaceutical facility?
What does the term 'specifications' refer to in a pharmaceutical facility?
What is the purpose of a Controlled Area in a pharmaceutical facility?
What is the purpose of a Controlled Area in a pharmaceutical facility?
What are some typical examples of areas classified as Level 1 in a pharmaceutical facility?
What are some typical examples of areas classified as Level 1 in a pharmaceutical facility?
Which of the following is NOT a typical parameter that should be qualified for a pharmaceutical facility's HVAC system?
Which of the following is NOT a typical parameter that should be qualified for a pharmaceutical facility's HVAC system?
What type of personnel should be qualified and trained for safety and hygiene in a pharmaceutical facility?
What type of personnel should be qualified and trained for safety and hygiene in a pharmaceutical facility?
What is the main source for auditing and inspection by quality personnel in a pharmaceutical facility?
What is the main source for auditing and inspection by quality personnel in a pharmaceutical facility?
What does 'documentation' serve as in a pharmaceutical facility?
What does 'documentation' serve as in a pharmaceutical facility?
