QUALITY CONTROL AND QUALITRY ASSURANCE

 Sampling,
 Inspecting,
 Testing,
 Monitoring,
Releasing/Rejecting
of starting materials,
 Packaging
materials,
Intermediates,
 Bulk products
Finished products.

Quality control is a day to day
process of controlling the quality
within an organization by
technically competent and
qualified staff responsible for the
acceptance or rejection of raw
materials and finished products.

Functions of Quality Control:
1.Quality control department of pharmaceutical
company responsible for sampling of raw
materials.
2.This department is also responsible for decision
maker that may affect the quality o product.
3.This dept. also responsible for documentation of
all the batches in the organization.
4.Q.C. dept. has to decide the release of final
product to the market.
5.Q.C. dept. helps in keeping the quality of the
product during manufacturing by taking samples.

Def.: Quality assurance refers to the
responsibility of an organization to
ensure or assure that systems, facilities
and written procedures, Standard
operating procedures, Current good
manufacturing practices are followed in
order to ensure that the final product
will meet all the applicable
specifications.

 QA Inspector
 QA Executive
 Document
Controller
 QMS - Co-
ordinator
 Validation Co-
ordinator
 QA Manager

“Quality assurance is wide ranging
concept that includes all matters that
individually or jointly influence the
quality of product.
It is the sum of all practices which
performed to maintain quality of drug.
Therefore Q.A. incorporate good
manufacturing practices in addition to
other factors.

Q.A. dept. is responsible for/functions of Q.A:
Quality assurance must be supported by team
effect.
 Responsible for Process design.
 Process Design Is The Design Of Processes For
Desired Physical And/Or Chemical Transformation
Of Materials
 Responsible for space.

 Responsible for Ventilation.
 Responsible for cleanliness.
 Responsible for environmental control and
sanitation.
 Validation.(It is the documented act of
demonstrating that a procedure, process, and
activity will consistently lead to the expected
results.)

Sources of Impurities:
1) Raw Material.
2) Reagents used in the manufacturing process.
3) Intermediate products in the manufacturing process.
4) Defects in the manufacturing process.
5) Solvents.
6) Action of solvents and reagents with reaction
vessels.
7) Atmospheric contamination during the manufacturing
process.
8) Defective storage of final products.
9) Adulteration.

1) Raw Material:
Eg. Copper turnings do contains iron and
arsenic as impurities.
Cu + 2H2SO4 CuSO4 + 2H2O
+ SO2
When zinc as taken as raw material for
the manufacturing of zinc sulphate then
it may contain Aluminum, copper,
magnesium, manganese, Nickel, arsenic
as impurities.
Zn + H2SO4 ZnSO4 + H2.

2) Reagents used in the
manufacturing process:
Eg. If final product i.e.
Ammoniated mercury is not washed
then ammonium hydroxide will
remain as impurity.
HgCl2 + 2NH4OH NH2HgCl
+ NH4Cl.

3) Intermediate products in the manufacturing process:
Eg. Potassium iodine is intermediate product
and if it is not completely converted into KI
then it may be present as an impurity.
KIO3 + 3C KI + 3CO
4) Defects in the manufacturing process:
Eg. If CaCO3 and HCl are not mixed then some
hydrochloric acid may till remain unreacted
form which will act as an impurity.
CaCO3 + 2HCl CaCl2 + H2O + CO2.
5) Solvents:
Eg. Water contains Cl-
, Ca+2
, Na+
, SO-2
&
HCO-3
impurities.

6) Action of solvents and reagents with reaction vessels:
Some solvents and reagents may react with the
metals of the reaction vessels during the manufacturing
processes and may dissolve these metals which appear as
impurities in the final products.
7) Atmospheric contamination during the manufacturing
process:
Eg. During crystallization of odium hydroxide as
final product exposed to air containing CO2.
NaOH readily absorbs CO2 and forms sodium
carbonate, therefore sodium hydroxide should
not be exposed to atmosphere for a long time
during it’s manufacturing.
2NaOH + CO2 Na2CO3 + H2O.

8) Defect storage of final product:
Eg.
i. When iodine is stored in contact with rubber
cork it reacted with it.
ii. KI is deliquescent should stored in air tight
container.
iii. Ferrous sulphate is converted into ferric
sulphate which is brown in colour.
9) Adulteration:
Addition of cheaper chemicals or
substances.
Eg. Potassium bromide may be adulterated with
sodium bromide. Potassium bromide is more
expensive than sodium bromide.

Effect of Impurities in a medicinal
substance:
1.Have a toxic effect and be dangerous when present
beyond certain limits.
2.Cause a change in the physical and chemical properties of
the substance.
3.Cause an incompatibility with other substances.
4.Lead to technical difficulties in the formulations.
5.Decrease the shelf life of the formulations.
6.SHOWS cumulative /toxic effects.

“Assay”
Def.: Assay is the quantitative determination of the
compound in the given product to asses whether it
confirms to the stated standards or not. i.e
percentage purity.
Assays are;
1. Gravimetric methods.
2. Volumetric assay.
a) Acid-Base titration.
b) Redox titration.
c) Iodometric titration.
d) Precipitation titration.
e) Complexometric titrations.
f) Diazotization titration.
g) Non-aqueous titrations.

“Limit Tests”
Limit tests are:
1)Limit test for Chlorides.
2)Limit test for Sulphates.
3)Limit test for Iron.
4)Limit test for Lead.
5)Limit test for Heavy Metals.
6)Limit test for Arsenic (Gutzeit’s apparatus).
“Identification Tests”
# Assays, Limit tests and Identification tests: Refer to
Pharmaceutical chemistry practical manual in detail.

LIFETRANSFORMER
PROF.SANDIP MAVCHI 20

QUALITY CONTROL AND QUALITRY ASSURANCE

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QUALITY CONTROL AND QUALITRY ASSURANCE