Q.C. work in industrial training by huzaifa ali

1. SHAMBHUNATH INSTITUTE OF
PHARMACY
PRESENTATION OF INDUSTRIAL TRAINING
PRESENTED BY– HUJAIPHA ANSARI
B.PHARN-3rd YEAR
1524150021
Under the guidance of:
DR. M.K. MISHRA

2. INDUSTRY PROFILE
NAME PARK BENZ LABORATORIES
ADDRESS &
CONTACT
Plot no. 92,New Industrial Area-II,
Mandideep, Distt. Raisen(M.P.)
Email:-park_benzlab@rediffmail.com
MAIN
ACTIVITY
Manufactured & Exporter of small
volume parenterals
PLANT
MANAGER
R.K. Kathal

3. INTRODUCTION
 Parenterals are the sterile dosages form
 The term parenteral is derive from two Greek word
Para (out side)
Entron (intestine)
o So it is a route of administration other than the
alimentary canal (gut)
o This route of administration by passes the alimentary
canal

4. REQUIREMENT OF PARENTERAL PREPARATION
 All product must be sterile
 All product must be free from pyrogenic (endotoxin)
contamination
 Injectable solution must be free from visible particulate
matter
 Product should be isotonic
 All product must be stable
 Product must be compatible
 API & pharma ingredient used must be special purity and
other standards
 Specific and high quality packaging

5. SOME PARENTERALS PRODUCTS OF
LABORATORIES
 Vitamin B12
 Chlorphenamine (CPM)
 Gentamycin
 Dxtramethasone

6. VARIOUS SECTION IN INDUSTRY
 Warehouse
 Water system
 Production
 Quality control
 Quality assurance

7. QUALITY CONTROL
TEST FOR
PARENTERAL
PRODUCT

8. UNIFORMITY OF CONTENT
TEST FOR VOLUME OF LIQUIDE
TEST FOR PYROGEN
TEST FOR STERILITY
CLARITY OF SOLUTION
UNIFORMITY OF WEIGHT
LEAKAGE TEST

9. UNIFORMITY OF CONTENT
 30 sterile unit are selected form each batch.
 The weight of 10 individual sterile unit is noted and the
content is remove from then and empty individual
sterile unit is weighed accurately again.
 Then net weight is calculated by subtracting empty
sterile unit weight from gross weight
 The dose uniformity is made is the amount of active
ingredient is within the range of 85-115.0% of label
claim
 Relative standard deviation equal to or less than 6.0%

10.  If one unit is outside the range of 85-115.0%, and
none of the sterile unit is outside of range 75-
125.0%of if the relative standard deviation of the
resultant is greater than 6.0%, or if both condition
prevail, an additional 20 sterile unit should be tested
 The sterile units meet the requirement if not more
then one unit side the range 85-115.0%, no unit is
outside the range of 75-125.0% and the calculated
relative standard deviation is 7.8%

11. TEST FOR VOLUME OF LIQUIDE
 Test applied to liquid supplied in single dose,
only part of the content is used
 Empty content of one container & determine
the volume of contents
 Emulsions and suspensions shake the
container before the determination
 The volume is not less than the amount stated
on the label

12. PARENTERAL
PREPARATION
MINIMUM NUMBER OF
ITEMS TESTED
Not more than 100 containers 10% or 4 containers
More than 100 but not more
than 500 containers
10 containers
More than 500 containers 2% or 20 containers
whichever is less
For large volume parenterals 2% or 20 containers
whichever is less

13. TEST FOR PYROGEN
 The test involve measurement of the rise in body
temperature of rabbis following the IV injection of a
sterile solution into ear vein of rabbit
 Dose not exceeding 10 ml per kg injected
intravenously with in the period of not more than 10
min.
 Test animal :- Use healthy adult rabbits of either sex
preferably of the same variety
 Recording of temperature : Clinical thermometer

14. TEST FOR STERILITY
 Sterility is define as a freedom from the presence
of viable microorganism
Method A :
Membrane
filtration
Method B:
Direct
inoculation

15. MEDIA TO BE USED IN THE STERILITY TEST
Fluid
Thioglycolate
Medium Soyabean-
casein digest
Medium

16. UNIFORMITY OF WEIGHT
 Remove the labels & wash the container and dry
 Weight the container along with content
 Empty the container completely
 Rinse with water & ethanol, dry at 100degree to
a constant weight
 Cool & weight
 Net weight should be calculated

17. LEAKAGE TEST
 Leakage test is employed to test package integrity
 Package integrity reflect it’s ability to keep the protect in an
to keep potential contamination out
 PROCEDURE:-
TAKE AMPOULES OR VIALSCONTAUNS SAMPLE
INSERT THE AMPOULES IN 1% METHYLENE BLUE
SOLUTION
OBSERVE THE COLOUR OF SAMPLE BEFORE
AND OFTER TEST

18. IF COLOUR
CHANGE OCCUR
THEN LEAKAGE IS
PRESENT
IF COLOUR CHANGE
DOSE NOT OCCUR
THAN LEAKAGE IS
ABSENT

19. CLEARITY TEST
VISUAL
METHOD
•The ampoules are placed in dark background
observe light particles
•Light background observe dark particles
MICROSCOPIC
COUNT
METHOD
•A measure sample solution is filtered through
membrane filtration
•Particle observe in the microscope under
100x magnification
LIGHT
OBSTRUCTIVE
METHOD
•The particle observe in the solution cross the
light beam by using light beam instrument
•The particle measured and counted