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Pharmainform Pharmainform: RF Environment Survey
Pharmainform Pharmainform: RF Environment Survey
Pharmainform Pharmainform: RF Environment Survey
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Qualification|IQ|DQ|OQ|PQ|URS|FAT|SAT
Qualification is documented evidence that all the equipment, system, facility or utility
are designed, installed and operated in such a way that complies GMP
requirements and produces products of the desired quality all the time.
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Deze site gebruikt cookies van Google om services te leveren en verkeer te analyseren. Je IP-adres en user-agent
worden met Google gedeeld, samen met prestatie- en beveiligingsstatistieken om servicekwaliteit te garanderen,
RF environment survey
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RF environment survey
EMC test equipment for emmisions and immunity
Laplace Instruments Ltd
If we discuss in a detailed manner then some key factors are also the part of
qualification which are as follow
Explanation
To understand the qualification system i will try to explain it with a simple
example which is as follow,
For a specific job, a specifically qualified person is required.
For example in the pharmaceutical industry for the post of Production
Pharmacist, the qualification of a person should be Pharm D.
Only that person will qualify for the post who have required qualification
because if we hire a person with different qualifications we will not be able
to achieve the desired results.
In the same way, any new equipment, area, facility or utility should only
be used for a task in pharmaceutical industries if it is qualified for that
specific purpose.
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URSworden met GoogleSpecification)
(User Requirement gedeeld, samen met prestatie- en beveiligingsstatistieken om servicekwaliteit te garanderen,
RF environment survey
gebruiksstatistieken te genereren, misbruik te detecteren en maatregelen te treffen. Open
URS is a document that defines the requirement forMEER
use INFORMATIE
of equipment,OK
system utility or facility.
The first step for purchasing new equipment or to build an area or system
is the required specifications for that by the concerned department.
For that, a document is prepared which contains all the requirements
which we need for equipment or facility.
This document is called URS and it is sent to the supply chain
department.
The supply chain department finds a suitable vendor against that URS.
The audit of the vendor should be conducted and the vendor should be
qualified.
Also Read:
GMP vs cGMP and 21 CFR.
Explanation
Everyone in daily life prepares URS for routine purchasing but it may not
be in a written form.
For example, when we want to purchase a mobile phone we decide which
type of features should be present in that mobile phone e.g RAM size,
storage memory,Battery storage, Screen Size etc.
We prefer to purchase a mobile phone from a reputable shop.
In the same way for pharmaceutical purchasing of any equipment first,
we prepare URS in written form which contains required features and
then we send URS to the supply chain department.
Supply chain department sends this URS to the vendor.
Capacity Requirements.
Design Requirements like dimensions, MOC.
Software Requirements.
Safety Requirements.
Cleaning Requirements.
Operational Requirements.
Power Consumption.
Working Accuracy.
Lubrication Requirements.
Example
Suppose we want to buy a Bin Blender for mixing area in the pharmaceutical
industry.
URS for Bin Blender will include
RF environment survey
EMC test equipment for emmisions and immunity
Laplace Instruments Ltd
Also Read
Difference between Validation & Calibration.
Installation Qualification
It is documented evidence that the required equipment, facility or utility is
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RF environment survey
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Example
To understand installation qualification take an example of Bin Blender.
After SAT Bin Blender is installed in a mixing area.
All the electrical supplies are checked that they are properly connected.
Safety alarm is checked that it is installed.
All the spare parts are verified.
MOC (Material of construction) has verified according to the URS that it is
316L.
It is ensured that all the manuals and drawing are provided by the vendor.
Operational Qualification
After installation qualification, the equipment, facility or utility is ready for
operational qualification.
Operational qualification is documented evidence that the required
equipment, facility or utility works according to requirements.
Operational qualification is checking the operation of each component of
equipment.
Operational qualification is performed without load means in empty or as
built conditions with supplies and connections etc.
Different ranges and parameters are checked.
Low medium and high ranges are verified.
Verify working of safety parameters.
Operational SOPs are available.
Personnel training.
Assure that calibration, cleaning and operational parameters are
satisfactory.
Example
To understand the operational qualification take an example of a Bin Blender which
is previously installed according to Design qualification.
As we know that in OQ we test the components of equipment without load and
verifyDeze site operational
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ranges.van Google om services te leveren en verkeer te analyseren. Je IP-adres en user-agent
So we worden metrpm
will check Google
of thegedeeld, samen
empty Bin met prestatie- en beveiligingsstatistieken om servicekwaliteit te garanderen,
Blender.
RF environment survey
gebruiksstatistieken te genereren, misbruik te detecteren en maatregelen te treffen.
We will note the following Open
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rpm at the lowest speed
rpm at medium speed
rpm at highest speed
Performance Qualification
Performance qualification is documented evidence that the specific
equipment, system or utility is working properly to give desired results
under real working conditions.
Performance Qualification is carried out under load.
We ensure that the equipment which gives acceptable results without
load will produce the same results under load.
Placebo batch is run to get results under load.
Example
A Bin Blender which is previously installed in an area and is qualified in
the operational stage is tested for performance qualification.
We run the equipment in real working conditions under load to check that
all components produce the same results as in the empty pass stage.
In the bin blender, a placebo batch is added and its rpm are noted as in
OQ.
Safety features are checked during working conditions.
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RF environment survey
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