Good Manufacturing Practice and Quality Assurance 26
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Questions and Answers

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.

<p>False</p> Signup and view all the answers

The Clothier Report emphasized the need for poor staff training.

<p>True</p> Signup and view all the answers

Good Manufacturing Practice (GMP) includes equipment and facility.

<p>True</p> Signup and view all the answers

Basic requirements of GMP do not include qualified and trained personnel.

<p>False</p> Signup and view all the answers

Operators are not required to be trained to carry out procedures correctly under GMP.

<p>False</p> Signup and view all the answers

The role of a Qualified Person (QP) does not involve assuring that products meet specifications.

<p>False</p> Signup and view all the answers

Quality Control (QC) is not part of Good Manufacturing Practice (GMP).

<p>False</p> Signup and view all the answers

GMP requires documentation such as laboratory control records.

<p>True</p> Signup and view all the answers

GMP is not considered an important part in quality assurance (QA).

<p>False</p> Signup and view all the answers

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?

<p>True</p> Signup and view all the answers

GMP regulations are not enforced by law. Is this statement true?

<p>False</p> Signup and view all the answers

The Clothier Report was issued as a result of the Devonport Incident. Is this statement true?

<p>True</p> Signup and view all the answers

The total batch of the dextrose 5% drip feed solution consisted of 5,000 bottles. Is this statement true?

<p>False</p> Signup and view all the answers

Approximately one half of the sub-batch was contaminated. Is this statement true?

<p>False</p> Signup and view all the answers

The fault in the dextrose 5% drip feed solution was detected 10 months after the manufacture. Is this statement true?

<p>True</p> Signup and view all the answers

There were 4 deaths at Devonport Hospital due to the 5% Sterile Dextrose Solution. Is this statement true?

<p>False</p> Signup and view all the answers

The Clothier Report was issued on 12th Jul 1973. Is this statement true?

<p>False</p> Signup and view all the answers

The Lancet reported deaths of patients related to the use of 5% dextrose solution. Is this statement true?

<p>True</p> Signup and view all the answers

The topic of 'Sterilisation of Sterile 5% Dextrose' is discussed in the MPharm MPH117 course. Is this statement true?

<p>True</p> Signup and view all the answers

What is the primary objective of Good Manufacturing Practice (GMP)?

<p>To assure the quality of the product for safety and well-being of patients</p> Signup and view all the answers

Which regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors?

<p>Orange Guide</p> Signup and view all the answers

What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?

<p>Multiple deaths due to contamination</p> Signup and view all the answers

What did the Clothier Report emphasize?

<p>Poor staff training</p> Signup and view all the answers

What concept does 'cGMP' represent?

<p>Current Good Manufacturing Practice</p> Signup and view all the answers

Which statement best reflects the purpose of GMP regulations?

<p>To ensure that pharmaceutical products meet specific quality standards</p> Signup and view all the answers

What was the significance of the Clothier Report in relation to the Devonport Incident?

<p>It highlighted shortcomings that contributed to the incident</p> Signup and view all the answers

1

<p>Conducting internal audits of production facilities</p> Signup and view all the answers

What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?

<p>Thorough and effective training for all personnel involved in manufacturing</p> Signup and view all the answers

What was recommended to address the fault in the autoclave?

<p>Run the autoclave for 40 minutes at maximum temperature</p> Signup and view all the answers

What were the findings of the Clothier Report regarding instrument calibration?

<p>Instrument calibration was lacking</p> Signup and view all the answers

What is a key responsibility of a Qualified Person (QP)?

<p>Release products onto the market or for clinical trials</p> Signup and view all the answers

What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?

<p>Guarantee that every product meets its specifications</p> Signup and view all the answers

What is included in the documentation required by Good Manufacturing Practice (GMP)?

<p>Master production and control record</p> Signup and view all the answers

What did the Clothier Report emphasize regarding equipment and facility under GMP?

<p>Adequacy of equipment and facility cleaning</p> Signup and view all the answers

What is the role of Quality Assurance (QA) in relation to GMP?

<p>To guarantee that medicinal products meet required quality standards</p> Signup and view all the answers

What is NOT a basic requirement of Good Manufacturing Practice (GMP)?

<p>Use of automated manufacturing processes</p> Signup and view all the answers

What is an example of documentation required by GMP?

<p>(LPC) Laboratory control records only</p> Signup and view all the answers

What does Quality Control (QC) aim to achieve under GMP?

<p>Guarantee that every product complies with its specifications</p> Signup and view all the answers

'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true?

<p>No, it is false.</p> Signup and view all the answers

Which of the following is a key responsibility of a Qualified Person (QP) according to GMP?

<p>Assuring that products have been prepared according to all relevant requirements, including GMP.</p> Signup and view all the answers

What was the primary objective of Good Manufacturing Practice (GMP) as mentioned in the text?

<p>Assure the quality of the product for safety, well-being, and protection of the patients</p> Signup and view all the answers

What was the significance of the Clothier Report in relation to the Devonport Incident?

<p>Issued after the Devonport Incident to investigate the deaths related to the use of 5% dextrose solution</p> Signup and view all the answers

What concept does 'cGMP' represent?

<p>‘current GMP’</p> Signup and view all the answers

What were the findings of the Clothier Report regarding instrument calibration?

<p>The Clothier Report mentioned a lack of instrument calibration</p> Signup and view all the answers

What made the company implement Good Manufacturing Practice (GMP), as highlighted in the text?

<p>The Devonport Incident involving the 5% Sterile Dextrose Solution</p> Signup and view all the answers

What was recommended to address the fault in the autoclave according to the text?

<p>Faulty temperature recorders were used in the drains of the autoclave</p> Signup and view all the answers

What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?

<p>Orange Guide</p> Signup and view all the answers

What was the result of the Devonport Incident involving the 5% Sterile Dextrose Solution?

<p>Resulted in the death of 5 patients</p> Signup and view all the answers

What does Quality Control (QC) aim to achieve under GMP?

<p>Assure the quality of the product during production</p> Signup and view all the answers

What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?

<p>To monitor and improve GMP regulations</p> Signup and view all the answers

What are the main findings of the Clothier Report?

<p>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.</p> Signup and view all the answers

What are the basic requirements of Good Manufacturing Practice (GMP) related to manufacturing process and facilities?

<p>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.</p> Signup and view all the answers

What are the responsibilities of a Qualified Person (QP) according to GMP?

<p>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.</p> Signup and view all the answers

What is the objective of Quality Control (QC) as part of Good Manufacturing Practice (GMP)?

<p>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.</p> Signup and view all the answers

What are some examples of documentation required by Good Manufacturing Practice (GMP)?

<p>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.</p> Signup and view all the answers

What concept does 'cGMP' represent?

<p>Current Good Manufacturing Practice</p> Signup and view all the answers

What is the purpose of Quality Assurance (QA) in relation to GMP?

<p>To ensure that medicinal products are of the quality required by their intended use, by organizing arrangements to guarantee quality.</p> Signup and view all the answers

What are the good manufacturing practice (GMP) categories according to the text?

<p>Planning, documentation, equipment and facility, and quality control.</p> Signup and view all the answers

What is emphasized under Good Manufacturing Practice (GMP) with regards to staff training?

<p>Operators are trained to carry out procedures correctly, and records are made to demonstrate that all required steps were taken.</p> Signup and view all the answers

What were the findings of the Clothier Report regarding instrument calibration?

<p>The report found a lack of instrument calibration.</p> Signup and view all the answers

What was the significance of the Clothier Report in relation to the Devonport Incident?

<p>The report revealed serious faults, including gross negligence, and made recommendations to address the incident.</p> Signup and view all the answers

What was recommended to address the fault in the autoclave?

<p>Running the autoclave for 40 minutes at maximum temperature.</p> Signup and view all the answers

What was the primary objective of Good Manufacturing Practice (GMP) according to the text?

<p>To ensure the safety and well-being of patients by assuring the quality of the pharmaceutical products</p> Signup and view all the answers

What concept does 'cGMP' represent as mentioned in the text?

<p>Current Good Manufacturing Practice</p> Signup and view all the answers

What is the role of Quality Assurance (QA) in relation to GMP as mentioned in the text?

<p>To monitor and improve GMP regulations</p> Signup and view all the answers

What does Quality Control (QC) aim to achieve under GMP according to the text?

<p>To ensure that manufactured products meet specifications</p> Signup and view all the answers

What were the findings of the Clothier Report regarding instrument calibration as mentioned in the text?

<p>The report emphasized the need for regular instrument calibration</p> Signup and view all the answers

What was recommended to address the fault in the autoclave according to the text?

<p>Improving temperature monitoring in the autoclave drains</p> Signup and view all the answers

What was emphasized under Good Manufacturing Practice (GMP) with regards to staff training according to the text?

<p>The requirement for continuous staff training to minimize errors</p> Signup and view all the answers

What was the main fault not identified in the incident described in the text?

<p>Faulty temperature recorders in the drains</p> Signup and view all the answers

Which aspect did the Clothier Report emphasize as a finding in relation to equipment maintenance?

<p>Inadequate equipment cleaning</p> Signup and view all the answers

What is the primary objective of Good Manufacturing Practice (GMP) according to the text?

<p>Adherence to manufacturing process specifications</p> Signup and view all the answers

What is a key responsibility of a Qualified Person (QP) as per the text?

<p>Approval of master production records</p> Signup and view all the answers

What did the Clothier Report emphasize regarding staff training?

<p>Lack of procedure-specific training</p> Signup and view all the answers

What regulatory document provides rules and guidance for pharmaceutical manufacturers & distributors as mentioned in the text?

<p>Green Guide (Rules and Guidance for Pharmaceutical Distributors)</p> Signup and view all the answers

What was recommended to address the fault in the autoclave according to the text?

<p>Run the autoclave for 40 min at maximum temperature</p> Signup and view all the answers

What is NOT a basic requirement of Good Manufacturing Practice (GMP) according to the text?

<p>'Lack of instrument calibration' and maintenance logs</p> Signup and view all the answers

'cGMP' represents what concept as mentioned in the text?

<p>'Current Good Manufacturing Processes'</p> Signup and view all the answers

'Operators are not required to be trained to carry out procedures correctly under GMP.' Is this statement true according to the text?

<p>'False'</p> Signup and view all the answers

'Quality Control (QC)' is part of Good Manufacturing Practice (GMP).' Is this statement true according to the text?

<p>'True'</p> Signup and view all the answers

'Approximately one half of the sub-batch was contaminated.' Is this statement true according to the text?

<p>'False'</p> Signup and view all the answers

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