Sanitation of manufacturing premises, Mixups and cross contamination. Qa Qc Subject. First year M.pharmacy first semester Quality Assurance Department

1. Mahatma Gandhi Vidyamandir’s
Pharmacy college
Panchavati ,Nashik
Pharmaceutical Quality Assurance Department
Sub : Quality Assurance and Quality Control
Prepared By Guided by
Mr. Kunal Anil Suryawanshi Dr. K.V. Bhambar Sir
Roll NO:45
Presentation on
Sanitation of manufacturing premises, Mixups
and cross contamination.

2.  VISION-
To be a Centre of professional excellence by contributing honestly to the
pharmacist moulding process.
 MISSION-
Impart high quality education to graduates
Contribute to all spheres of professional activities
Uphold human values and ethics
Nature them into globally competent professional

3. Content
• Introduction
• Sanitization of manufacturing premises.
• Mix-ups
• Cross contamination

4. Introduction
 Manufacturing operation and control:
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
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5.  Introduction
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
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6.  SANITATION IN THE
MANUFACTURING PREMISES:
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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) b) cleaning procedure to be followed.
c) c) personnel assigned to and responsible for the cleaning operation.

7.  SANITATION IN THE
MANUFACTURING PREMISES:
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
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8.  SANITATION IN THE MANUFACTURING
PREMISES:
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
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9.  Documents required
• 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.
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10.  Mixups 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
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11.  Mix-ups and Cross-Contamination
 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
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12.  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
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13.  Precautions against mix-up and cross-
contamination
 The drug material and drug product (from environmental dust) by proper
air handling system.
 The processing of sensitive drugs like Beta lactum antibiotics, sex
hormones and cytotoxic substances is isolated production areas.
To prevent mix-up during production stages, material under process shall
he conspicuously labelled to demonstrate their status.
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14.  Precautions against mix-up and cross-
contamination
 The packaging lines, printing machines, and other equipment are clean and free
from any products, materials and spillages.
The manufacturing environment shall be maintained at the required levels of
temperature, humidity and cleanliness.
Authorised persons shall ensure change-over into specific uniforms before
undertaking and manufacturing operations including packaging.
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15. 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.
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16.  Controlling of mix ups and contamination
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.
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17.  Controlling of mix ups and contamination
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.
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18.  Reference
1) Sandy Weinberg, Good Laboratory Practice Regulations, 2nd Edition, Vol. 69,
Marcel Dekker Series, 1995.
2) Quality Assurance Guide by organization of Pharmaceutical Procedures of
India, 3rd revised edition, Volume I & II, Mumbai, 1996.
3) Pharmaceutical quality assurance by manohar A. Potdar
4) http://apps.who.int/medicinedocs/en/d/Js5517e/20.4.3 .html
5) https://www.slideshare.net/parth241989/gmp- premises-112070804006
6) https://eservices.personalcarecouncil.org/bbk/CS_January 17-2014.pdf
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19. THANK YOU
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