Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. In a pharmaceutical organization a quality control deals with testing, sampling, specification, and documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. There are several types of hormonal product in different dosage form. These hormonal product quality control and maintaining lies on their specific dosage system. The achievement of these test for hormonal product provides a significant challenge to ingenuity and creativity of hormonal scientist and technologist.

1. Quality control of Hormonal products
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured
product or performed service adheres to a defined set of quality criteria or meets the requirements
of the client or customer. In a pharmaceutical organization a quality control deals with testing,
sampling, specification, and documentation, release procedure which ensure that all tests are
actually carried out prior to release of material for sale or use. There are several types of hormonal
product in different dosage form. These hormonal product quality control and maintaining lies on
their specific dosage system. The achievement of these test for hormonal product provides a
significant challenge to ingenuity and creativity of hormonal scientist and technologist.
Dosage form of hormonal product
 Solid dosage form
 Semisolid dosage form
 Parenteral dosage form
Quality control of solid dosage form of hormonal products:
Quality Control test for Tablets
Disintegration Test: This is the official test which testifies the time required for a tablet to
disintegrate in the solution. The time required to break the tablet into fine particles. Disintegration
test helps in knowing the API solubility in the gastric fluids of the digestive system. This test is
ideal for all tablets but is not performed for controlled and sustained release tablets. Temperatures
are maintained accordingly for each tablet. It is calculated by the time required to dissolve the
tablet in the liquid and compared with the standard time in the pharmacopoeia.
Hardness: It is the load required to crush the tablet when placed on its edge. The test is performed
to meet the need for pressure adjustments on the tableting machine. Hardness affects the
disintegration test. If the tablet is too hard, it may not disintegrate in the required period of time.

2. And if the tablet is too soft, it will not withstand the handling during subsequent processing such
as coating or packaging. If the tablet hardness is too high, we first check its disintegration before
rejecting the batch. If the disintegration is within limit, we accept the batch.
General Appearance: The general appearance of a tablet, its identity and general elegance is
essential for consumer acceptance, for control of lot-to-lot uniformity and tablet-to-tablet
uniformity. The control of general appearance involves the measurement of size, shape, color,
presence or absence of odor, taste etc. Size and shape may vary from tablet to tablet
Color and Odor: Many pharmaceutical tablets use color as a vital means of rapid identification
and consumer acceptance. But it must be uniform within a single tablet, from tablet to tablet and
from lot to lot. The presence of an odor in a batch of tablets could indicate a stability problem e.g.
the characteristic odor of acetic acid in degrading aspirin tablets or could be characteristic of the
drugs e.g. vitamins have a characteristic odor. Taste is important in consumer acceptance of
chewable tablets
Unique Identification marking: These are used in the form of embossing, engraving or printing.
These can include the company identification marks, or any other symbols related to the dosage
form.
Friability: The Roche Friabillator is used to check the friability of the tablets. Initial weight of the
tablets is checked before placing them in the device and batches are separated to check accordingly.
Initial and final weight of the tablet is checked. Compress tablet that lose less than 0.5 to 1.0 % of
the Tablet weigh are consider acceptable. Friability is a often related to hardness testing.
Thickness test: Thickness test is performed for very few tablets as it is not a official test to
perform. Thickness of tablet is measured by Vernier caliper/screw gauge.
Weight Variation test: It is performed to check the uniformity of the tablet.

3. Dissolution test: Dissolution is an official test. Dissolution is performed to check the percentage
release from the dosage forms.
Before the tablets are processed they undergo evaluation tests which determine the right granule
testing procedure to compress the tablets.
Granules are the API formulations which are compressed to form the tablets. Granules are prepared
by combining the API, excipients and binders. This dough is used to prepare granules which are
dried and then undergo evaluation test.
1. Particle Size and Shape determination: The size and shape depends upon the processing
requirements and during granulation. The methods for determining the shape are: Sieving,
Sedimentation rate, Microscopy, Light screening.
2. Surface area of granules: This is generally used for drug substances but not for the granules.
Drug Content Determination
A physically sound tablet may not produce the desired effects. To evaluate a tablet potential for
Efficacy, the amount of drug per tablet needs to be monitored from tablet to tablet and batch to
Batch, and a measure of the tablets ability to release the drug needs to be ascertained.
Moisture Content of granules
Granules should possess sufficient strength to withstand normal handling and mixing processes
Without breaking down and producing large amounts of fine powder. On the other hand, some size
reduction during compaction into tablets is desirable to expose the areas of clean surface Necessary
for optimum bonding to take place so moisture content is the very important factor for
Producing god pharmaceutical product.
Assay of active ingredient
In a tablet an active ingredient is present which is called active pharmaceutical ingredient
(A.P.I).So to prepare the tablet assay has to be done to produce good finished product.

4. Quality control of semi-solid dosage form of hormonal products:
a) Drug contents determination.
b) Assay of active ingredients.
c) Uniformity and homogeneity test.
d) Viscosity and specific gravity test.
e) Filling test
Drug content determination
As all have discussed earlier drug content becomes important factor for active pharmaceutical
Product. Drug content has to be of very suitable ratio that it can give the pharmacological action.
Homogeneity test
The semi-solid preparations require further treatment are transferred or pumped to the proper
Homogenizer, the selection of which is governed by the degree and rate of shear stress required.
Viscosity and Specific gravity test
Once the desired semi-solid preparation have been chosen, a consistency that provides the desired
stability and has appropriate flow characteristics must be attained. For emulsion it is routinely
observed that the building up of viscosity in a freshly prepared emulsion requires some Time. The
is recommended, therefore that newly formulation emulsion be allowed to rest Undisturbed for 24
to 48 hours before it is determined whether its rheological properties correspond to those that are
required. The viscosity of emulsions responds to changes in composition in accordance with the
following generalizations.
There is a linear relationship between emulsion viscosity and viscosity of continous phase.
• The greater the volume of the internal phase, the greater is the apparent viscosity.
• To control emulsion viscosity, three interacting effects must be balanced by the formulator.
o The viscosity of o/w and w/o emulsions can be increased by the reducing the particle size of
the dispersed phase.
o Emulsion stability is improved by a reduction in particle in particle size.

5. o Flocculation or clumping which tends to structure the internal phase ,can be stabilizing
effect, it increases the viscosity .
Quality control of parenteral dosage form of hormonal products:
a) Drug contents determination.
b) Clarity test.
c) pH.
d) Pyrogen test.
e) Stability test.
f) Leakage test.
g) Check up of particulate matters.
Pyrogen test
The presence of pyrogenic substance in parenteral is determined by a qualitative biologic test
Based on the fever response of the rabbits. Rabbits are used as test animal because they show a
Physiologic response to pyroxenes similar to that of human beings. If a pyrogenic substance is
injected into the vein of a rabbit, an elevation of temperature occurs in a period of three hours.
Sterility test
All products labeled “sterile” must pass through sterility test, having been subjected to an
Effective process of sterilization. The traditional concept of sterilization is the absolute condition
Of total elimination of all the microorganisms. With a terminal methods of sterilization of a
Parenteral product, particularly steam under pressure, a probability of no more than one sterile
Unit in a million is readily achievable. The term aseptic indicates a controlled process in which
The level of microbial contamination is reduced to the degree that microorganisms can be
Excluded from a product during processing. It describes apparently sterile state.
Leaking test
Ampules are intended to provide hermetically sealed container for a single dose of a product,

6. Thereby completely barring any interchange between the contents of the sealed ampule and its
Environment. Should capillary pores or tiny cracks be present, microorganisms or other dangerous
contaminants may enter the ampule or the contents may leak to the outside and spoil The
appearance of the package. Changes in temperature during storage cause expansion and
contraction of the ampule and contents, thereby accentuating interchange if an opening exists.
Leakers usually detected by producing a negative pressure with an incompletely sealed ampule,
usually in a vaccum chamber, while the ampule is entirely submerged in a deeply coloured dye
solution ,usually 0.5 to 0.1% methylene blue. Subsuequent atmospheric pressure then causes dye
to penetrate an opening, being visible after the ampule has been washed externally to clear it of
dye. The vaccum (27 inches Hg or more) should be sharply released after30 min. Only a tiny
drop of dye may penetrate a small opening. Vials and bottles are not subjected to such a leaker
test because the rubber closure is not rigid; however, bottles are often sealed while a vacuum is
being pulled so that the bottle remains evacuated during its shelf life.
Clarity test
Clarity is the relative term, the meaning of which is markedly affected by the subjective
evaluation of the observer. Unquestionly a clean solution having a high polish conveys to the
observer that the product is of exceptional quality and purity .It is practically impossible,
however, to prepare a lot of a sterile product so that every unit of that lot is perfectly free from
visible particulate matter, that is , from particles that are 30 to 40 micrometer and larger in
size.Consequently it is the responsibility of the quality control department to detect and discard
individual containers of a product that the ultimate user would consider to be unclean.
This clarity test is performed in industry by visual inspection machine by the light baffles against
reflection into the eyes, and views against a black and white background, with the contents set in
motion with a swirling action.
Stability
To enhance the assurance of successful manufacturing operations, all process steps must be
carefully reduced to writing after being shown to be effective. These process steps are often
called standard operating procedures(SOPs).No extemporaneous changes are permitted to be
made in these procedures; any change must go through the same approval steps as the original

7. written SOP. Further external records must be kept to give assurance at the end of the production
process that all steps have been performed as prescribed. Such in-process control is essential to
assuring the quality of the product, since these assurances are even more significant than those
from product release testing.
CONCLUSION
Monitoring chemical processes for the formation of an API is the first step to ensuring quality in
pharmaceutical manufacturing. Having reliable and reproducible methods will enable the
production plant to guarantee the consistency of drugs batch after batch. Furthermore, it may
simplify the characterization of such processes and their chemical profile. Through the years,
vast publications and general information have been presented to pharmaceutical industry
specialists about the validation of analytical methods. Federal and international regulatory groups
have published various guidelines to shed light on analytical method validation. No such
emphasis has been given, or guidelines described, however, the validation of in- process control
methods. This article intends to establish a starting point for discussions about the validation of
in- process methods. So in this, in- process methods quality control and validation are dealed
with several of criteria that are discussed in this review.

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