What is the difference between a strip pack and a blister pack?
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The difference between a strip pack
and a blister pack is that a strip pack doesn’t have thermoformed or cold
formed cavities; the strip pack is formed around the tablet or capsule when
it is dropped to the sealing area between sealing moulds.
Blister packing contain PVC/PVDC
foil in one side and
Aluminum foil in the other side,
whereas in Strip packs contains aluminum foil in both sides.
Advantage:
The Al/PE laminated film has the same protective property as cold forming aluminum film, that perfectly protects the medicine from moisture, light and oxygen.
Disadvantages:
Slower speed of production compared to thermoforming blister pack; Because it doesn’t have pre-formed cavities, the packaging area for each item is larger than the blister pack. |
What is the difference between Calibration and Validation?
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Calibration is the demonstration that, a particular instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
Whereas Validation is a documented
program that provides high degree of assurance that a specific process,
method or system consistently produces a result meeting pre-determined
acceptance criteria. In calibration performance of an instrument or device is
comparing against a reference standard. But in validation such reference
standard is not using.
Calibration ensures that instrument
or measuring devices producing accurate results. Whereas validation
demonstrates that a process, equipment, method or system produces consistent results
(in other words, it ensures that uniforms batches are produced).
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What is the difference between Disintegration and Dissolution?
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Disintegration is a disaggregation
process, in which an oral dosage form falls apart in to smaller aggregates (Disintegration
time is the ‘break up’ time of a solid dosage form).
Whereas dissolution is a process by
which solid substance enters in the solvent to yield a solution. It is
controlled by the affinity between the solid substance and the solvent.
In other word disintegration is a
subset of dissolution.
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What is the difference between FDA Form 482 and 484?
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FDA Form 482 – Notice of Inspection
Form 482 is an official notice of
FDA inspection. This document gives FDA the authority to enter a facility and
inspect as per section 704 of the FD&C act.
FDA Form 484 – Receipt for Samples
Form 484 is an acknowledgement of
samples received by FDA as per section 704 of the FD&C act.
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Form 483 and Warning Letter’s are
two serious documents issued by USFDA which are very different in
regulatory and legal prospective. “FDA 483 lists observations made by
the FDA representative during the inspection of a facility. They are
inspectional observations, and do not represent a final Agency determination
regarding firms compliance.” The FDA-483 can be amended after an
inspection by the investigator who issued it and re-issued.
The Warning Letter is a document
that usually originates from the FDA-483 observations that have been linked
to citations by one or more legal reviews within the Compliance and legal
branch of the FDA. A Warning Letter is informal and advisory. It
communicates the agency's position on a matter, but it does not commit FDA to
taking enforcement action. For these reasons, FDA does not consider Warning
Letters to be final agency action on which it can be sued. The Warning
Letter is issued by the agency and not the investigator.
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What is the
difference between Hard Gelatin and Soft Gelatin Capsules?
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Both the
hard and softgel capsules are made of gelatin.Thus the difference between
these two types of capsules lies in the design and manufacturing technology
which are detailed below.
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What is the
difference between Humidity and Relative Humidity?
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"Humidity"
and "Relative Humidity" is not the same thing. Humidity means
amount of water vapour present in air with respect to total amount of
air. Relative Humidity is the amount of moisture in the air 'relative'
to the temperature (i.e relative humidity is the amount of moisture
in the air compared to what the air can "hold" at that temperature.
When the air can't "hold" all the moisture, then it condenses as
dew).
The relative humidity is a
measure of the amount of water vapor in the air (at a specific temperature)
compared to the maximum amount of water vapor air could hold at that
temperature, and is given as a percentage value. Relative humidity depends on
the temperature of the air.
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What is the difference between KF and LOD?
In
pharmaceuticals, several methods are employed to determine the water content
of a substance/product. Among which Karl Fischer Titration (KF) and Loss on
Drying (LOD) are most honored and largely reliable methods.
Loss-on-Drying
(Weight Loss)
This
method uses the principle of drying a sample of the product and comparing the
weight before and after drying. The difference in weight represents the
moisture that is in the product. This can be accomplished by using various
manner such as drying ovens, infrared balances, and infrared lamps.
Whatsoever, the drying conditions are strictly specified. The difference in
weight after drying is due to the loss of all evaporated matter, which is
taken to represent the moisture content. Repeatability and accuracy of
this method solely depend up on the temperature and time controls adopted
during testing.
The
difficulty is that this technique measures all the moisture lost from the
sample, which includes not just water but also any other volatile component
already present in the sample (like residual volatile solvents) or created by
polymerization or degradation of the sample.
Karl Fischer
(KF) Titration
Karl
Fischer titration is a very specific determination method which detects and
measures only water, including water of crystallization and surface-absorbed
water. It is based upon a redox reaction involving water and iodine in the
presence of a base, an alcohol, and sulfur dioxide. The water-iodine reaction
is dependent upon the presence of water, and therefore the titer of reagent
used up in the reaction reflects the amount of water in the sample as there
is no other source of water.
The
KF reagent contains iodine and when it has completely reacted with the total
water, excess iodine appears in the solution, causing a color change as well
as an electrometric change which can be detected by a double platinum
electrode. KF titration measures total water and is not affected by the
presence of residual volatile solvents. It has a wide and sensitive range of
determination from a water content of 100% to 1 ppm.
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What is the difference between mg and IU?
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Basically Mg
is mass......... IU is effect
Milligrams (mg) are a measure of mass(weight). A milligram is one thousandth of a gram. International Units (IU) are a measure based on the biological activity of a substance in the body. These units are arbitrarily set by a committee of researchers commissioned by the World Health Organization. The goal is to provide a measure of the effect on the body a substance will have regardless of its mass. For Ex: 1 IU of Vitamin C is 50 mgs, but 1 IU of insulin is .045 milligrams. That's for the pure crystalline versions of those chemicals: a different preparation or a related chemical may have the same effect using a different amount, and that would also be 1 IU. IU is used for vitamins, hormones, some drugs, vaccines, blood products and similar biologically active substances. Despite its name, the IU is not part of the International System of Units used in physics and chemistry. |
What is the difference between Thermoforming and Cold forming
Technology in Blister packing?
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Thermoforming is a technique
that involves heating sheets of PVC prior to insertion into a blister
machine. This is typically achieved by passing the sheets between upper and
lower heating plates. When a sheet enters a thermoforming blister
machine, it is soft and pliable and can be forced to take on the shape of a
mold through the application of pressure. In some cases, a mechanical stamp
will be used in addition to the application of pressure, particularly when
the shape of the mold is difficult or complex.
Cold forming is a technique that does not involve any application of heat. Unlike the thermoforming method that uses clear PVC, this technique uses thin sheets of laminate film that contain aluminum. In order to create packaging out of these sheets, a blister machine will typically use a stamp to force it into a form. The aluminum-based film will tend to stretch and retain the shape after the stamp has been removed. This type of blister pack is typically used to contain pharmaceuticals, since the aluminum-based film tends to prevent moisture from entering the packaging. |
What is the difference between Warning Letter and Untitled
Letter?
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If a person or firm violates the
Federal Food, Drug and Cosmetic Act (FD&C Act), FDA may give them an
opportunity to take voluntary and prompt action to correct the violation
before FDA initiates an enforcement action. FDA will issue either a Warning Letter or an Untitled Letter,
depending upon the nature of the violation.
FDA uses Warning Letters for violations that may lead to enforcement action if they are not promptly and adequately corrected. FDA uses Untitled Letters for violations that are not as significant as those that trigger warning letters. Unlike a Warning Letter, an Untitled Letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action.
An Untitled Letter cites violations
that do not meet the threshold of regulatory significance for a Warning
Letter. An Untitled Letter differs from FDA warning letter in following
aspects.
Warning
Letter VS Untitled Letter
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What is the difference between ALCOA and ALCOA Plus?
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ALCOA and ALCOA Plus are acronyms related
to data integrity.
When the concept of Data integrity
was first introduced in late 90’s, regulatory agencies used the term ALCOA to
indicate the main 5 principles of data integrity, which are referring to
Attributable, Legible, Contemporaneous, Original and Accurate.
Later on the concept of ALCOA Plus
introduced to the industry indicating the 5 main principles of data integrity
(i.e Attributable, Legible, Contemporaneous, Original and Accurate) plus
additional emphasis on the attributes of being complete, consistent, enduring
and available.
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What is the
difference between Contamination and Cross Contamination?
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Contamination is the undesired introduction of impurities (of chemical
and microbiological nature) or foreign matter, into or onto a starting
material or intermediate, API or finished product during: storage, sampling,
processing, packing or transport.
Whereas Cross contamination is the contamination of a starting
material, Intermediate or finished product with another starting material,
intermediate or product.
Reason for contamination/cross contamination of drug substance/product
can vary and caused by multiple factors. Facility constraints, lack of
procedures, lack of awareness etc. are the few among them.
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What is the difference between Reference Listed Drug (RLD) and
Reference Standard (RS) in Orange Book?
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Reference Listed Drug
(RLD): An RLD is the specific listed drug on which an ANDA applicant
relies in seeking approval for its ANDA.
Reference Standard (RS):
A reference standard (RS) is a listed drug selected by FDA that an ANDA
applicant must use in conducting an In-vivo bio equivalence study.
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What is the difference between GDUFA
and PDUFA?
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Both GDUFA
and PDUFA are US FDA’s User Fee programs, which help FDA to hire and retain
sufficient numbers and types of technical and scientific experts to
efficiently conduct reviews of human drug applications (NDA and ANDA) and
improving the predictability of review processes GDUFA is related to ANDAs whereas PDUFA is related to NDAs.
GDUFA: Generic Drug User Fee Amendments. The Generic Drug User Fee Act is a
law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry.
PDUFA: Prescription Drug User Fee
Act is a law passed by the United States Congress
in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
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What is the
difference between Biologics and Bio similar ?
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Biologics or biological products are medicines made from living
organisms through highly complex manufacturing processes and must be handled
and administered under carefully monitored conditions.
Biologic: A biological product or biologic, is a preparation, such as
a therapeutic drug, monoclonal antibodies or vaccines, that is made from
living organisms (such as microorganisms, animal cell or plant cell).
Compared with conventional chemical drugs, biologics are relatively large and
complex molecules. They may be composed of proteins (and or their constituent
amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or
combinations of these substances. Patients receives biologics by injection
under skin (subcutaneously) or by intravenous infusion and cannot take them
orally, since the digestive process break down the biologic and make them
ineffective.
Bio similar: A Bio similar
is similar but not identical to a brand name biologic medicine (reference product).
Bio similar has the same mechanism of action, route of administration, dosage
form, and strengths as the brand name biologic
medicine (reference product). Bio similar is highly similar, but not structurally
identical and exact replicas of the brand-name biologic; there can be minor
differences in clinically inactive components. Because biologics are
more complex than chemical drugs, both in composition and method of
manufacture. Since bio similars are not identical, they are not generic
versions of the biologic they are copying, but they are affordable
alternatives that work similarly and are shown in studies to have equivalent
outcomes.
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