manufacturing operation and control

1. PRESENTED BY :
S A C H I N PAWA R M P H A R M F. Y. [ Q A ]
GUIDED BY:
R . S . S A K H A R E S I R
S C H O O L O F P H A R M A C Y S RT M U N N A N D E D .
MANUFACTURING
OPERATION AND CONTROLS

2. Contents
 1 Sanitization of manufacturing premises
 2. Mix ups
 3 Cross contamination
 4. Processing of intermediates and bulk product
 5. References

3. Manufacturing operation and control:
1 All manufacturing operations shall be carried out
under the supervision of technical staff approved by
the Licensing Authority
Precautions against mix-up and cross contamination-
1. By proper air handling system, pressure differential,
segregation, status labelling and cleaning. Proper
records and SOP there of shall be maintained.
2. Processing of sensitive drugs and cytotoxic
substances in segregated areas

4. 3.Proper labelling of materials and equipments
4. Packaging lines shall be independent and
adequately segregated
5. All printing and overprinting shall be
authorized in writing
6. The manufacturing environment maintained at
the required levels of temperature, humidity and
cleanliness

5. SANITATION IN THE MANUFACTURING
PREMISES :
1] The manufacturing premises shall be cleaned and in an
orderly manner
2] The manufacturing areas shall not be used for other
operations
3 ]A routine sanitation program shall be drawn up which
shall be properly recorded and which indicate–
a) specific areas to be cleaned and cleaning intervals
b) cleaning procedure to be followed
c) personnel assigned to and responsible for the cleaning
operation.

6. 4.Sanitizatin maintain the manufacturing area ,free from dust
,insect ,dust ,debris
Waste or trash material
5. Their may be containers of suitable size and shape
{containers may be made from either Plastic or any other
material }
6. Cleaning all these premises with detergent
7. Premises again wash with disinfectant

7. IN TABLET MANUFACTURING :
1. Powder clean with best napkins
2. After completion clean with disinfectant solution
i.e. 1% glycol solution
Glass material :
1. Glass material and residue collected in wastage
2. All glasses are clean by 70% isopropyl alcohole

8. DOCUMENTATION REQUIRED:
1. Sop on housekeeping , covering ,cloning and
disinfectant of the various areas
2. Reports of cleaning and disinfection
activities that have been actually carried out

9. Mix ups and cross contamination:
Mix ups can be defined as presence of undesired
material
into desirable material ,which can generally be visible
seen
Ex: paracetamol mix with diclofinac
Tablet of one product into another ,which having different
size , shape
Contamination:
Contamination may be defined as presence of the
undesired
Material , it should be not visible
Ex: fine dust of one product into another product

10. Source of mix ups and contamination
Contamination and mix ups are presence of
undesired things in desirable things .
These contamination can be from various source
e.g. 1. material
2. area
3. machine and equipment
4. people

11. Precautions against mix-up and cross-
contamination
1)The drug material and drug product (from environmental
dust) by proper air handling system.
2) The processing of sensitive drugs like BetaLactum
antibiotics, sex hormones and cytotoxic substances is
isolated production areas.
3)To prevent mix-up during production stages, material
under process shall he conspicuously labelled to
demonstrate their status.

12. 4) The packaging lines, printing machines, and other
equipment are clean and free from any products,
materials and spillages.
5)The manufacturing environment shall be maintained at
the required levels of temperature, humidity and
cleanliness.
6) Authorised persons shall ensure change-over into
specific uniforms before undertaking and manufacturing
operations including packaging.

13. Controlling of mix ups and contamination
A] EXHAUST SYSTEM
Certain procedure should be used to control mix
ups and contamination
 exhaust system with proper air filtration and
dust collection
 there should be separate air handling unit
Their should be air pressure control maintained
Packaging unit should be well separated i.e
1.2-1.5 m in two adjacent packaging line

14. B] TRAINED PEOPLE:
In pharma processing the people should be trained in
their job and also in their principle of CGMP
It should having discipline procedure of correct
procedure ,products training and equipment handling

15. C] TEACHNICAL MEASURE
1. Production in segregated area
2. Provide appropriate air loss and system
3. Always use the cleaning equipment
4. Using a close system for material handling
and production

16. Processing of intermediates and bulk products
Starting from the receipt of raw material till these
Material are converted into bulk goods ready for
Packaging into their primary and then finished
packs
 certain points are required to be kept in mind
So That the identify , strength , safety , and purity
Of the product is maintained

17. 1. Before starting any processing the material received
from the store should be checked for the identity and
quality
This verification can be done against labels on their
containers
2. Process area and equipment must be clean and no
trace of previous product should be their

18. 3. Environmental condition must meet the processing
requirement
E.g.
temperature
pressure
relative humidity
class of air
lighting etc
4. All primary containers used for filling finished product
Should be clean to be acceptable level of cleanliness

19. 5. Yield of material at all critical stage of operation should
be checked and compared against theoretical yield
expected
E.g. Granulation
compression
filling operation of capsule
liquid bottle etc
6. Any abnormal deviation must be investigated and
corrective action taken

20. 7. Check should be carried out to ensure pipeline and other
equipment used for transportation of product from one area
to another connected in correct manner
8 .Such pipe line thoroughly cleaned and sanitized to get
desired
Level of limit of microbial presence

21. 9. All measuring , weighing , recording , and controlling
equipment and instrument
Should be calibrated regularly .
10. Record of such calibration should be maintained
11. Repairs and maintenance of operations should not
present any hazard to the quality of product

22. 12. All IPQC checks should be carried out at pre -
determined stages and deviation should Be recorded and
investigated
13. Access to production area should be restricted only to
authorized person

23. DOCUMENTS REQUIRED
1] B.P.C.R for each batch produced
2] calibration records

24. References:
1. Pharmaceutical quality assurance by manohar A.
potdar
2. http://apps.who.int/medicinedocs/en/d/Js5517e/20.4.3
.html
3. https://www.slideshare.net/parth241989/gmp-
premises-112070804006
4. https://eservices.personalcarecouncil.org/bbk/CS_Jan
uary17-2014.pdf