84 Questions
Faulty temperature recorders were used in the drains of the autoclave.
True
The company decided that the vacuum was not okay.
False
The Clothier Report mentioned a lack of instrument calibration.
True
The Clothier Report found adequate and operational procedures.
False
The Clothier Report emphasized the need for poor staff training.
True
Good Manufacturing Practice (GMP) includes equipment and facility.
True
Basic requirements of GMP do not include qualified and trained personnel.
False
Operators are not required to be trained to carry out procedures correctly under GMP.
False
The role of a Qualified Person (QP) does not involve assuring that products meet specifications.
False
Quality Control (QC) is not part of Good Manufacturing Practice (GMP).
False
GMP requires documentation such as laboratory control records.
True
GMP is not considered an important part in quality assurance (QA).
False
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?
True
GMP regulations are not enforced by law. Is this statement true?
False
The Clothier Report was issued as a result of the Devonport Incident. Is this statement true?
True
The total batch of the dextrose 5% drip feed solution consisted of 5,000 bottles. Is this statement true?
False
Approximately one half of the sub-batch was contaminated. Is this statement true?
False
The fault in the dextrose 5% drip feed solution was detected 10 months after the manufacture. Is this statement true?
True
There were 4 deaths at Devonport Hospital due to the 5% Sterile Dextrose Solution. Is this statement true?
False
The Clothier Report was issued on 12th Jul 1973. Is this statement true?
False
The Lancet reported deaths of patients related to the use of 5% dextrose solution. Is this statement true?
True
The topic of 'Sterilisation of Sterile 5% Dextrose' is discussed in the MPharm MPH117 course. Is this statement true?
True
What is the primary objective of Good Manufacturing Practice (GMP)?
To assure the quality of the product for safety and well-being of patients
Which regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors?
Orange Guide
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
Multiple deaths due to contamination
What did the Clothier Report emphasize?
Poor staff training
What concept does 'cGMP' represent?
Current Good Manufacturing Practice
Which statement best reflects the purpose of GMP regulations?
To ensure that pharmaceutical products meet specific quality standards
What was the significance of the Clothier Report in relation to the Devonport Incident?
It highlighted shortcomings that contributed to the incident
1
Conducting internal audits of production facilities
What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
Thorough and effective training for all personnel involved in manufacturing
What was recommended to address the fault in the autoclave?
Run the autoclave for 40 minutes at maximum temperature
What were the findings of the Clothier Report regarding instrument calibration?
Instrument calibration was lacking
What is a key responsibility of a Qualified Person (QP)?
Release products onto the market or for clinical trials
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
Guarantee that every product meets its specifications
What is included in the documentation required by Good Manufacturing Practice (GMP)?
Master production and control record
What did the Clothier Report emphasize regarding equipment and facility under GMP?
Adequacy of equipment and facility cleaning
What is the role of Quality Assurance (QA) in relation to GMP?
To guarantee that medicinal products meet required quality standards
What is NOT a basic requirement of Good Manufacturing Practice (GMP)?
Use of automated manufacturing processes
What is an example of documentation required by GMP?
(LPC) Laboratory control records only
What does Quality Control (QC) aim to achieve under GMP?
Guarantee that every product complies with its specifications
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true?
No, it is false.
Which of the following is a key responsibility of a Qualified Person (QP) according to GMP?
Assuring that products have been prepared according to all relevant requirements, including GMP.
What was the primary objective of Good Manufacturing Practice (GMP) as mentioned in the text?
Assure the quality of the product for safety, well-being, and protection of the patients
What was the significance of the Clothier Report in relation to the Devonport Incident?
Issued after the Devonport Incident to investigate the deaths related to the use of 5% dextrose solution
What concept does 'cGMP' represent?
‘current GMP’
What were the findings of the Clothier Report regarding instrument calibration?
The Clothier Report mentioned a lack of instrument calibration
What made the company implement Good Manufacturing Practice (GMP), as highlighted in the text?
The Devonport Incident involving the 5% Sterile Dextrose Solution
What was recommended to address the fault in the autoclave according to the text?
Faulty temperature recorders were used in the drains of the autoclave
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
Orange Guide
What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?
Resulted in the death of 5 patients
What does Quality Control (QC) aim to achieve under GMP?
Assure the quality of the product during production
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
To monitor and improve GMP regulations
What are the main findings of the Clothier Report?
Lack of instrument calibration, lack of maintenance activities, inadequate and lack of operational procedures, inadequate equipment cleaning, poor staff training, and no batch records review.
What are the basic requirements of Good Manufacturing Practice (GMP) related to manufacturing process and facilities?
Defined, reviewed and consistently manufactured processes, validated critical steps, and provision of qualified and trained personnel, premises, space, equipment, correct materials, containers, labels, approved procedures, and instructions.
What are the responsibilities of a Qualified Person (QP) according to GMP?
Releasing products onto the market or for clinical trials, ensuring products are prepared according to GMP and meet specifications, actively involved in all aspects relating to quality, and being registered with the correct experiences and training.
What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?
To ensure that when followed, the defined process will yield a product complying with its specifications and that the product contains correct ingredients, has been correctly processed, is of the required purity, and is enclosed in proper containers with correct labels.
What are some examples of documentation required by Good Manufacturing Practice (GMP)?
Equipment cleaning and use records, records of raw materials, intermediates, API labeling and packaging materials, master production and control records, batch production and control records, standard operating procedures, laboratory control records, and product review.
What concept does 'cGMP' represent?
Current Good Manufacturing Practice
What is the purpose of Quality Assurance (QA) in relation to GMP?
To ensure that medicinal products are of the quality required by their intended use, by organizing arrangements to guarantee quality.
What are the good manufacturing practice (GMP) categories according to the text?
Planning, documentation, equipment and facility, and quality control.
What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?
Operators are trained to carry out procedures correctly, and records are made to demonstrate that all required steps were taken.
What were the findings of the Clothier Report regarding instrument calibration?
The report found a lack of instrument calibration.
What was the significance of the Clothier Report in relation to the Devonport Incident?
The report revealed serious faults, including gross negligence, and made recommendations to address the incident.
What was recommended to address the fault in the autoclave?
Running the autoclave for 40 minutes at maximum temperature.
What was the primary objective of Good Manufacturing Practice (GMP) according to the text?
To ensure the safety and well-being of patients by assuring the quality of the pharmaceutical products
What concept does 'cGMP' represent as mentioned in the text?
Current Good Manufacturing Practice
What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?
To monitor and improve GMP regulations
What does Quality Control (QC) aim to achieve under GMP according to the text?
To ensure that manufactured products meet specifications
What were the findings of the Clothier Report regarding instrument calibration as mentioned in the text?
The report emphasized the need for regular instrument calibration
What was recommended to address the fault in the autoclave according to the text?
Improving temperature monitoring in the autoclave drains
What was emphasized under Good Manufacturing Practice (GMP) with regards to staff training according to the text?
The requirement for continuous staff training to minimize errors
What was the main fault not identified in the incident described in the text?
Faulty temperature recorders in the drains
Which aspect did the Clothier Report emphasize as a finding in relation to equipment maintenance?
Inadequate equipment cleaning
What is the primary objective of Good Manufacturing Practice (GMP) according to the text?
Adherence to manufacturing process specifications
What is a key responsibility of a Qualified Person (QP) as per the text?
Approval of master production records
What did the Clothier Report emphasize regarding staff training?
Lack of procedure-specific training
What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?
Green Guide (Rules and Guidance for Pharmaceutical Distributors)
What was recommended to address the fault in the autoclave according to the text?
Run the autoclave for 40 min at maximum temperature
What is NOT a basic requirement of Good Manufacturing Practice (GMP) according to the text?
'Lack of instrument calibration' and maintenance logs
'cGMP' represents what concept as mentioned in the text?
'Current Good Manufacturing Processes'
'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true according to the text?
'False'
'Quality Control (QC)' is part of Good Manufacturing Practice (GMP).' Is this statement true according to the text?
'True'
'Approximately one half of the sub-batch was contaminated.' Is this statement true according to the text?
'False'
Learn about the principles and guidelines of Good Manufacturing Practice (GMP) and its objective to assure the quality of pharmaceutical products for safety and well-being of patients. Understand the concept of GMP and its constant monitoring and improvement.
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