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WorksheetsCLPT, M.Pharmacy, Pharmaceutical Regulatory Affairs
Total questions: 40
Worksheet time: 42mins
The topics included under ICH are
Quality
Safety
Efficacy
All
The countries included under ICH are
European Union
Japan
USA
All
Which is correct guidelines for stability testing
ICH Q3
ICH Q10
ICHQ8
ICHQ1
Data from stability studies should be provided on at least ................... primary batches of the drug product.
4
3
2
5
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as ..........................................., and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions
Temperature, and light
Heat, temperature, and light
Temperature, humidity, and light
Temperature, humidity, and moisture
For Intermediate stability studies as per the ICH guidelines which storage condition for the drug substance is applicable
25°C ± 2°C/60% RH ± 5% RH
30°C ± 2°C/65% RH ± 5% RH
40°C ± 2°C/75% RH ± 5% RH
None
For Accelerated stability studies as per the ICH guidelines which storage condition for the drug substance is applicable
40°C ± 2°C/75% RH ± 5% RH
30°C ± 2°C/65% RH ± 5% RH
25°C ± 2°C/60% RH ± 5% RH
None
For long term stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a refrigerator is applicable
25°C ± 2°C/60% RH ± 5% RH
5°C ± 3°C
30°C ± 2°C/65% RH ± 5% RH
40°C ± 2°C/75% RH ± 5% RH
For Accelerated stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a refrigerator is applicable
5°C ± 3°C
25°C ± 2°C/60% RH ± 5% RH
30°C ± 2°C/65% RH ± 5% RH
25°C ± 2°C/60% RH ± 5% RH
For long term stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a freezer is applicable
5°C ± 3°C
- 20°C ± 5°C
25°C ± 2°C/60% RH ± 5% RH
30°C ± 2°C/65% RH ± 5% RH
As per the ICH quality guidelines, sub-section Q1C deals with...............
STABILITY TESTING FOR NEW DOSAGE FORMS
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
EVALUATION FOR STABILITY DATA
None
GxP stands for?
Good Manufacturing Practices
Good Clinical Practices
Good Laboratory Practices
All the above
cGMP Prohibits false therapeutic claims
True
False
Not Sure
May be
Training is not a GMP requirement
True
False
Protect materials and product from contamination and restricted access are the GMP requirement
True
False
Which of the following statements are correct?
Processes should be Validated, Robust, Produce uniform product, Protect product from contamination, Controlled, Cleanable and kept clean
There should be procedures for all pieces of equipment that explain how to disassemble, how to clean, how to reassemble, how to operate, and where necessary, how to trouble shoot
Quality needs to be designed into the product from the very beginning of its lifecycle
All the above
5P’s covers People, Premises, Product, Processes and Procedures
True
False
Contamination may be caused by
poor hygiene practices
inadequate cleaning
residual cleaning agents
All of the above
API stands for 'active pharmaceutical ingredient'
True
False
Manufacture of sterile medicines does not require strict controls on Line clearance and Line opening
True
False
cGMP allows the user to perform the modification of equipment without approval
True
False
Water is a major source of microbial contamination so we take high effort to control the water purity during manufacturing of pharmaceutical products
True
False
Quality is built into every step of the process (quality-by-design) as products cannot be 100% tested at the end of manufacture
True
False
Batch Records must be Legible, Accurate, Factual, Timely, Permanent, Traceable to person and equipment and retained
True
False
cGMP stands for?
Compendium Good Monitoring Practices
Compendium Good Manufacturing Practices
Current Good Manufacturing Practices
Current Good Monitoring Practices
'OOS' means
Out-of-specific
Out-of-specification
Out-of-signal
None
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
Verification
Qualification
Specification
Validation
The date when a material should be re-examined to ensure that it is still suitable for use.
Expiry date
Retest Date
Manufacturing date
None
The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained
Quality Assurance
Quality Control
Process Control
Manufacture
Any material intended to protect an intermediate or API during storage and transport.
Drug Substance
Material
Packaging Material
None
'CPP' means
Critical Procedure Parameter
Critical Process Protocol
Critical Process Parameter
None
'CQA' means
Critical Quality Attribute
Critical Quantity Attribute
Critical Quality Analysis
None
'QbD' means
Quality by Development
Quality by Design
Quality by Dose
None
'QTPP' means
Quality Target Protocol Profile
Quality Target Product Procedure
Quality Target Product Profile
None
The suitability of either a drug substance or a drug product for its intended use.
Quality unit
Quality control
Quality assurance
Quality
The potential source of harm
Risk
Hazard
Danger
None
All phases in the life of the product from the initial development through marketing until the product’s discontinuation.
Product Limit
Product Life
Product Lifecycle
None
The combination of the probability of occurrence of harm and the severity of that harm.
Risk
Harm
Hazard
None
The estimation of the risk associated with the identified hazards.
Risk Assessment
Risk Identification
Risk Analysis
Risk Control
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.
Risk Reduction
Risk Review
Risk Management
Risk Identification
