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Questions and Answers
Faulty temperature recorders were used in the drains of the autoclave.
Faulty temperature recorders were used in the drains of the autoclave.
True (A)
The company decided that the vacuum was not okay.
The company decided that the vacuum was not okay.
False (B)
The Clothier Report mentioned a lack of instrument calibration.
The Clothier Report mentioned a lack of instrument calibration.
True (A)
The Clothier Report found adequate and operational procedures.
The Clothier Report found adequate and operational procedures.
The Clothier Report emphasized the need for poor staff training.
The Clothier Report emphasized the need for poor staff training.
Good Manufacturing Practice (GMP) includes equipment and facility.
Good Manufacturing Practice (GMP) includes equipment and facility.
Basic requirements of GMP do not include qualified and trained personnel.
Basic requirements of GMP do not include qualified and trained personnel.
Operators are not required to be trained to carry out procedures correctly under GMP.
Operators are not required to be trained to carry out procedures correctly under GMP.
The role of a Qualified Person (QP) does not involve assuring that products meet specifications.
The role of a Qualified Person (QP) does not involve assuring that products meet specifications.
Quality Control (QC) is not part of Good Manufacturing Practice (GMP).
Quality Control (QC) is not part of Good Manufacturing Practice (GMP).
GMP requires documentation such as laboratory control records.
GMP requires documentation such as laboratory control records.
GMP is not considered an important part in quality assurance (QA).
GMP is not considered an important part in quality assurance (QA).
Good manufacturing practice (GMP) aims to assure the quality of the product for safety, well-being, and protection of the patients. Is this statement true?
Good manufacturing practice (GMP) aims to assure the quality of the product for safety, well-being, and protection of the patients. Is this statement true?
GMP regulations are not enforced by law. Is this statement true?
GMP regulations are not enforced by law. Is this statement true?
The Clothier Report was issued as a result of the Devonport Incident. Is this statement true?
The Clothier Report was issued as a result of the Devonport Incident. Is this statement true?
The total batch of the dextrose 5% drip feed solution consisted of 5,000 bottles. Is this statement true?
The total batch of the dextrose 5% drip feed solution consisted of 5,000 bottles. Is this statement true?
Approximately one half of the sub-batch was contaminated. Is this statement true?
Approximately one half of the sub-batch was contaminated. Is this statement true?
The fault in the dextrose 5% drip feed solution was detected 10 months after the manufacture. Is this statement true?
The fault in the dextrose 5% drip feed solution was detected 10 months after the manufacture. Is this statement true?
There were 4 deaths at Devonport Hospital due to the 5% Sterile Dextrose Solution. Is this statement true?
There were 4 deaths at Devonport Hospital due to the 5% Sterile Dextrose Solution. Is this statement true?
The Clothier Report was issued on 12th Jul 1973. Is this statement true?
The Clothier Report was issued on 12th Jul 1973. Is this statement true?
The Lancet reported deaths of patients related to the use of 5% dextrose solution. Is this statement true?
The Lancet reported deaths of patients related to the use of 5% dextrose solution. Is this statement true?
The topic of 'Sterilisation of Sterile 5% Dextrose' is discussed in the MPharm MPH117 course. Is this statement true?
The topic of 'Sterilisation of Sterile 5% Dextrose' is discussed in the MPharm MPH117 course. Is this statement true?
What is the primary objective of Good Manufacturing Practice (GMP)?
What is the primary objective of Good Manufacturing Practice (GMP)?
Which regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors?
Which regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors?
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
What did the Clothier Report emphasize?
What did the Clothier Report emphasize?
What concept does 'cGMP' represent?
What concept does 'cGMP' represent?
Which statement best reflects the purpose of GMP regulations?
Which statement best reflects the purpose of GMP regulations?
What was the significance of the Clothier Report in relation to the Devonport Incident?
What was the significance of the Clothier Report in relation to the Devonport Incident?
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What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
What was recommended to address the fault in the autoclave?
What was recommended to address the fault in the autoclave?
What were the findings of the Clothier Report regarding instrument calibration?
What were the findings of the Clothier Report regarding instrument calibration?
What is a key responsibility of a Qualified Person (QP)?
What is a key responsibility of a Qualified Person (QP)?
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
What is included in the documentation required by Good Manufacturing Practice (GMP)?
What is included in the documentation required by Good Manufacturing Practice (GMP)?
What did the Clothier Report emphasize regarding equipment and facility under GMP?
What did the Clothier Report emphasize regarding equipment and facility under GMP?
What is the role of Quality Assurance (QA) in relation to GMP?
What is the role of Quality Assurance (QA) in relation to GMP?
What is NOT a basic requirement of Good Manufacturing Practice (GMP)?
What is NOT a basic requirement of Good Manufacturing Practice (GMP)?
What is an example of documentation required by GMP?
What is an example of documentation required by GMP?
What does Quality Control (QC) aim to achieve under GMP?
What does Quality Control (QC) aim to achieve under GMP?
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true?
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true?
Which of the following is a key responsibility of a Qualified Person (QP) according to GMP?
Which of the following is a key responsibility of a Qualified Person (QP) according to GMP?
What was the primary objective of Good Manufacturing Practice (GMP) as mentioned in the text?
What was the primary objective of Good Manufacturing Practice (GMP) as mentioned in the text?
What was the significance of the Clothier Report in relation to the Devonport Incident?
What was the significance of the Clothier Report in relation to the Devonport Incident?
What concept does 'cGMP' represent?
What concept does 'cGMP' represent?
What were the findings of the Clothier Report regarding instrument calibration?
What were the findings of the Clothier Report regarding instrument calibration?
What made the company implement Good Manufacturing Practice (GMP), as highlighted in the text?
What made the company implement Good Manufacturing Practice (GMP), as highlighted in the text?
What was recommended to address the fault in the autoclave according to the text?
What was recommended to address the fault in the autoclave according to the text?
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
What does Quality Control (QC) aim to achieve under GMP?
What does Quality Control (QC) aim to achieve under GMP?
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
What are the main findings of the Clothier Report?
What are the main findings of the Clothier Report?
What are the basic requirements of Good Manufacturing Practice (GMP) related to manufacturing process and facilities?
What are the basic requirements of Good Manufacturing Practice (GMP) related to manufacturing process and facilities?
What are the responsibilities of a Qualified Person (QP) according to GMP?
What are the responsibilities of a Qualified Person (QP) according to GMP?
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
What are some examples of documentation required by Good Manufacturing Practice (GMP)?
What are some examples of documentation required by Good Manufacturing Practice (GMP)?
What concept does 'cGMP' represent?
What concept does 'cGMP' represent?
What is the purpose of Quality Assurance (QA) in relation to GMP?
What is the purpose of Quality Assurance (QA) in relation to GMP?
What are the good manufacturing practice (GMP) categories according to the text?
What are the good manufacturing practice (GMP) categories according to the text?
What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
What were the findings of the Clothier Report regarding instrument calibration?
What were the findings of the Clothier Report regarding instrument calibration?
What was the significance of the Clothier Report in relation to the Devonport Incident?
What was the significance of the Clothier Report in relation to the Devonport Incident?
What was recommended to address the fault in the autoclave?
What was recommended to address the fault in the autoclave?
What was the primary objective of Good Manufacturing Practice (GMP) according to the text?
What was the primary objective of Good Manufacturing Practice (GMP) according to the text?
What concept does 'cGMP' represent as mentioned in the text?
What concept does 'cGMP' represent as mentioned in the text?
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
What does Quality Control (QC) aim to achieve under GMP according to the text?
What does Quality Control (QC) aim to achieve under GMP according to the text?
What were the findings of the Clothier Report regarding instrument calibration as mentioned in the text?
What were the findings of the Clothier Report regarding instrument calibration as mentioned in the text?
What was recommended to address the fault in the autoclave according to the text?
What was recommended to address the fault in the autoclave according to the text?
What was emphasized under Good Manufacturing Practice (GMP) with regards to staff training according to the text?
What was emphasized under Good Manufacturing Practice (GMP) with regards to staff training according to the text?
What was the main fault not identified in the incident described in the text?
What was the main fault not identified in the incident described in the text?
Which aspect did the Clothier Report emphasize as a finding in relation to equipment maintenance?
Which aspect did the Clothier Report emphasize as a finding in relation to equipment maintenance?
What is the primary objective of Good Manufacturing Practice (GMP) according to the text?
What is the primary objective of Good Manufacturing Practice (GMP) according to the text?
What is a key responsibility of a Qualified Person (QP) as per the text?
What is a key responsibility of a Qualified Person (QP) as per the text?
What did the Clothier Report emphasize regarding staff training?
What did the Clothier Report emphasize regarding staff training?
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
What was recommended to address the fault in the autoclave according to the text?
What was recommended to address the fault in the autoclave according to the text?
What is NOT a basic requirement of Good Manufacturing Practice (GMP) according to the text?
What is NOT a basic requirement of Good Manufacturing Practice (GMP) according to the text?
'cGMP' represents what concept as mentioned in the text?
'cGMP' represents what concept as mentioned in the text?
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true according to the text?
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true according to the text?
'Quality Control (QC)' is part of Good Manufacturing Practice (GMP).' Is this statement true according to the text?
'Quality Control (QC)' is part of Good Manufacturing Practice (GMP).' Is this statement true according to the text?
'Approximately one half of the sub-batch was contaminated.' Is this statement true according to the text?
'Approximately one half of the sub-batch was contaminated.' Is this statement true according to the text?
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