PHM 241 midterm exam questions with
complete solutions32
What is GMP? - ANSWERS-GMP is a set of regulations that ensures the quality of
:•Drugs
•Medical devices
•Blood
•Some types of food
GMP regulations cover - ANSWERS-•Manufacturing processes
•Manufacturing facilities
•Processing
•Packaging and/or storage
who sets GMP guidelines - ANSWERS-ICH
•Guideline Q7(2000)
•Good Manufacturing Practice Guidance for Active Pharmaceutical Ingred
FDA
•First established in 1962
•cGMP (Current Good Manufacturing Practice)
Health Canada Implemented (2018)
•Good manufacturing practices guide for drug products(GUI-0001
,•Why is GMP important? - ANSWERS-To ensure that products are consistently produced
•and controlled according to quality standards.
•It is designed to minimize the risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.
FDA milestones - ANSWERS-Pure Food and Drugs Act(1906)
The drug and Cosmetic Act(1938)
Biologics Control Act (1902)
drug manufacturers Where does GMP fit in ensuring quality? - ANSWERS-Drug manufacturers
must develop a Pharmaceutical Quality System that incorporates Good Manufacturing Practices
and carries out Quality Control.`
PQS - ANSWERS-pharmaceutical quality system "wide ranging concept that covers all matters
that individually or collectively influence the quality of a drug".
PQS includes GMP.
manufacturing GMP - ANSWERS-"The part of a PQS that ensures that drugs are consistently
produced and controlled in such a way to meet the quality standards appropriate to their
intended use, as required by the market authorization". GMP includes QC
manufacturing QC - ANSWERS-"The part of GMP that is concerned with sampling, specifications,
testing, documentation and release procedures."
Quality control ensures that the necessary and relevant tests are carried out and that raw
materials, packaging materials, and products are released for use or sale, only if their quality is
satisfactory"
,health canada: To meet GMP requirements, you must: - ANSWERS-1. Clearly define all
manufacturing processes. Rational: consistently manufacture quality drugs that comply with
theirspecifications
.2.Validate critical steps of manufacturing processes
3.Provide all key elements for GMP
4. Write step-by-step instructions and procedures in clear and directlanguage.
5. Train operators to properly carry out procedures.
6.Create records (manually and/or by recording instruments) during manufacture.
7.Document any deviations.
8.Keep records of fabrication, packaging, labelling, testing, distribution,importation and
wholesaling in an easy-to-understand and accessible form.
9.Distribute products in accordance to Canadian good distribution practice
.10.Control storage, handling and transportation of drugs to minimize any risk to their quality.
11.Have a system in place for recalling drugs from sale.
, key elements for GMP - ANSWERS-a.qualified and trained staff
b.adequate premises and space
c.suitable equipment and services
d.correct materials, containers and labels
e.approved procedures and instructions
f.suitable storage and transport
Health Canada: Quality Control - ANSWERS-Quality Control is the part of GMP that is concerned
with:
•Sampling
•Specifications
•Testing
•Documentation
•Release procedures
To meet basic quality control requirements, youmust: - ANSWERS-1.Ensure you have adequate
facilities, trained personnel and approved procedures for sampling and testing of raw materials,
packaging materials, intermediate bulk and finished products.
2.Take samples using authorized personnel and approved methods.
3.Validate test methods. Qualify equipment, instruments and computer systems for their
intended use.
4.Keep records
complete solutions32
What is GMP? - ANSWERS-GMP is a set of regulations that ensures the quality of
:•Drugs
•Medical devices
•Blood
•Some types of food
GMP regulations cover - ANSWERS-•Manufacturing processes
•Manufacturing facilities
•Processing
•Packaging and/or storage
who sets GMP guidelines - ANSWERS-ICH
•Guideline Q7(2000)
•Good Manufacturing Practice Guidance for Active Pharmaceutical Ingred
FDA
•First established in 1962
•cGMP (Current Good Manufacturing Practice)
Health Canada Implemented (2018)
•Good manufacturing practices guide for drug products(GUI-0001
,•Why is GMP important? - ANSWERS-To ensure that products are consistently produced
•and controlled according to quality standards.
•It is designed to minimize the risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.
FDA milestones - ANSWERS-Pure Food and Drugs Act(1906)
The drug and Cosmetic Act(1938)
Biologics Control Act (1902)
drug manufacturers Where does GMP fit in ensuring quality? - ANSWERS-Drug manufacturers
must develop a Pharmaceutical Quality System that incorporates Good Manufacturing Practices
and carries out Quality Control.`
PQS - ANSWERS-pharmaceutical quality system "wide ranging concept that covers all matters
that individually or collectively influence the quality of a drug".
PQS includes GMP.
manufacturing GMP - ANSWERS-"The part of a PQS that ensures that drugs are consistently
produced and controlled in such a way to meet the quality standards appropriate to their
intended use, as required by the market authorization". GMP includes QC
manufacturing QC - ANSWERS-"The part of GMP that is concerned with sampling, specifications,
testing, documentation and release procedures."
Quality control ensures that the necessary and relevant tests are carried out and that raw
materials, packaging materials, and products are released for use or sale, only if their quality is
satisfactory"
,health canada: To meet GMP requirements, you must: - ANSWERS-1. Clearly define all
manufacturing processes. Rational: consistently manufacture quality drugs that comply with
theirspecifications
.2.Validate critical steps of manufacturing processes
3.Provide all key elements for GMP
4. Write step-by-step instructions and procedures in clear and directlanguage.
5. Train operators to properly carry out procedures.
6.Create records (manually and/or by recording instruments) during manufacture.
7.Document any deviations.
8.Keep records of fabrication, packaging, labelling, testing, distribution,importation and
wholesaling in an easy-to-understand and accessible form.
9.Distribute products in accordance to Canadian good distribution practice
.10.Control storage, handling and transportation of drugs to minimize any risk to their quality.
11.Have a system in place for recalling drugs from sale.
, key elements for GMP - ANSWERS-a.qualified and trained staff
b.adequate premises and space
c.suitable equipment and services
d.correct materials, containers and labels
e.approved procedures and instructions
f.suitable storage and transport
Health Canada: Quality Control - ANSWERS-Quality Control is the part of GMP that is concerned
with:
•Sampling
•Specifications
•Testing
•Documentation
•Release procedures
To meet basic quality control requirements, youmust: - ANSWERS-1.Ensure you have adequate
facilities, trained personnel and approved procedures for sampling and testing of raw materials,
packaging materials, intermediate bulk and finished products.
2.Take samples using authorized personnel and approved methods.
3.Validate test methods. Qualify equipment, instruments and computer systems for their
intended use.
4.Keep records
