Definition,Difference bet GMP and cGMP,Protocols of GMP,Genaral Consideration,Premises,Equipment etc

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2. GMP:-
That part of QA which ensures that
products are consistently produced and
controlled to the quality standards as per the
specifications.
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4. •1902 - Development of the Biologic Control Act
•1906 - Development of the Pure Food and Drug Act
•1938 - Federal Food, Drug and Cosmetic Act
•1941 - Initiation of GMP
•1944 - Development of Public Health Services Act
•1962 - Kefauver-Harris Drug Amendments released
•1963 - Establishment of GMPs for Drugs
•1975 - CGMPs for Blood and Components Final Rule
•1976 - Medical Device Amendments
•1978 - cGMPs for Drugs and Medical Devices
•1979 - GLPs Final Rule
•1980 - Infant Formula Act is passed
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5. Warehousing Area
Reference Samples
 Validation and process validation
Labels And Other Printed Materials
QA
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6.  Compliance with GMP
 Consistent uniform batches
 Location And surroundings
 Water system
 Disposal Of Waste
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7. Qualified Personnel
a)Experienced
b)Sufficient Number
Written job description
Trained
Health
a)Diseases
b)Open Lesions
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8. Location
Design
Construction
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9.  Geography, climate , and economic factors
 Neighbours
a) What can happen?
Premises must be located to minimize risks of cross-contamination,
e.g. not located next to a malting factory with high airborne levels of
yeast
Pollution/effluent control
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10. Minimize risks of errors
Permit effective cleaning
Permit effective maintenance
Avoid cross-contamination, build-up of dirt and dust
Maximum protection against entry of insects, birds
and animals
Separate facilities for other products such as some
antibiotics, hormones, cytotoxic substances
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11.  Eating , Drinking, Smoking Should not be allowed in
the Production area.
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12. 1. Measures should be taken to prevent cross-
contamination
2. Dust control measures (including extraction of dust
and air)
3. No areas for dust accumulation
4. Easily cleanable surfaces
5. Proper air supply
6. Use of HEPA filter’s
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13.  Equipment shall be located, designed, constructed,
adapted and maintained to suit the operation to be
carried out.
 Should be made of non reactive material, such as High
grade of steel(316,302)
 Equipment should be-
a) Calibrated
b)Checked
c)labeled
d)Sterilized
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14.  Written procedures
• hygiene, health and clothing practices
• waste disposal
 Implementation and training
 Practices not permitted
a)eating, smoking
b) unhygienic practices
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15.  There shall be written Standard Operating Procedure for
each operation
 It include-
a)For Equipments
b)For sampling
c)For Testing
d)For Process
f)For Packaging
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16.  An Inventory should be maintained for Raw materials
to be used at any stage of manufacture
 Records should be maintain as per Schedule U
 Should be purchased from approved sources
 Must be checked by QC department on recipt
 Should be labeled.
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17.  There shall be MFR relating to all manufacturing procedures for
each product and batch size to be manufacture
 It should include-
i)The name of the product
ii)Quantity, of all starting materials to be used
iii)A statement of the expected final yield with acceptable
limits.
iv) Principal equipment to be used
v) Detail stepwise processing instructions and the time taken for
each step
vi)Any special precautions
vii)Packing details and Specimen labels
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18. PROTOCOL AS PER GMP
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19. PROTOCOL FOR INDUSRTY
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20.  There shall be Batch processing record for each product.
 During Manufacturing or Processing the following
information shall be recorded
 It include-
The name of the product
The number of Batch being manufactured
Dates and time of commencement of batch and
completion
Initials of operator
Amount of Product obtained
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21. I. Warehousing area should be designed and adapted
to ensure good storage conditions.
II. Should be Clean, dry and maintained with
acceptable temperature limits.
III. Should have appropriate house-keeping and
rodents, pests and vermin control.
IV. Separate sampling area for active raw material and
exciepients.
V. Every Material stored should be labeled properly.
Fire Prevention
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22.  Essential part of GMP
 Necessary to achieve the intended results
 A written record is prepared summarizing recorded result and
conclusions shall be prepared ,documented and maintained
 Should be necessary when-
 a)Any new master formula or method of
preparation is adopted
b)For critical process
c)any changes in the equipment, or when
using a new equipment, it is first validated
to demonstrate its consistentency of
required quality
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23. PROTOCOL FOR VALIDATION
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24.  All containers and equipment should bear labels
 Different color coded labels should be used to indicate
the status of a product(for example under
test,approved,passed,rejected)
 The Printing should be done in bright colors
 The label should contain all the prescribed details
about the product.
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