Good manufacturing practice

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2. CONTENT
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 Definition
 Difference between GMP &cGMP
 Time line of GMP
 Personnel
 Premises
 Equipment
 SOP(Standard Operating Process)
 Master Formula Record and Batch ManufacturingRecord
 Validation and Validation Process &Protocols

3. GMP:-
That part of QA which ensures that
products are consistently produced and
controlled to thequality standards as per the
specifications.
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5. •1902 - Development of the Biologic ControlAct
•1906 - Development of the Pure Food and DrugAct
•1938 - Federal Food, Drug and Cosmetic Act
•1941 - Initiation of GMP
•1944 - Development of Public Health ServicesAct
•1962 - Kefauver-Harris Drug Amendmentsreleased
•1963 - Establishment of GMPs for Drugs
•1975 - CGMPs for Blood and Components Final Rule
•1976 - Medical Device Amendments
•1978 - cGMPs for Drugs and MedicalDevices
•1979 - GLPs Final Rule
•1980 - Infant Formula Act ispassed
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6. Warehousing Area
Reference Samples
 Validation and processvalidation
Labels And Other PrintedMaterials
QA
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7.  Compliance with GMP
 Consistent uniformbatches
 Location And surroundings
 Watersystem
 Disposal Of Waste
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8. Qualified Personnel
a)Experienced
b)Sufficient Number
Written jobdescription
Trained
Health
a)Diseases
b)Open Lesions
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9. Location
Design
Construction
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10.  Geography, climate , and economicfactors
 Neighbours
a) What can happen?
Premises must be located to minimize risks of cross-contamination,
e.g. not located next toa malting factorywith high airborne levels of
yeast
Pollution/effluent control
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11. Minimize risksof errors
Permit effectivecleaning
Permit effectivemaintenance
Avoid cross-contamination, build-up of dirt anddust
Maximum protection against entry of insects,birds
and animals
Separate facilities forotherproductssuch as some
antibiotics, hormones, cytotoxicsubstances
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12.  Eating , Drinking, Smoking Should not be allowedin
the Productionarea.
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13. 1. Measures should be taken topreventcross-
contamination
2. Dust control measures (including extractionof dust
and air)
3. No areas for dustaccumulation
4. Easily cleanablesurfaces
5. Proper airsupply
6. Use of HEPA filter’s
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14.  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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15.  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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16.  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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17.  An Inventory should be maintained for Rawmaterials
to be used atany stageof manufacture
 Records should be maintainas per Schedule U
 Should be purchased from approvedsources
 Must bechecked by QC departmenton recipt
 Should be labeled.
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18.  There shall be MFR relating to all manufacturingprocedures for
each product and batch size to be manufacture
 It should include-
i)The name of theproduct
ii)Quantity, of all starting materials to beused
iii)A statementof the expected final yield with acceptable
limits.
iv) Principal equipment to beused
v)Detail stepwise processing instructionsand the time taken for
each step
vi)Any special precautions
vii)Packing details and Specimenlabels
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19. PROTOCOL AS PER GMP
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20. PROTOCOL FOR INDUSRTY
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21.  There shall be Batch processing record foreach product.
 During Manufacturing or Processing thefollowing
information shall berecorded
 It include-
The name of theproduct
The number of Batch being manufactured
Dates and time of commencement of batchand
completion
Initials of operator
Amount of Productobtained
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22. I. Warehousing area should bedesigned and adapted
to ensure good storageconditions.
II. Should be Clean, dry and maintainedwith
acceptable temperaturelimits.
III. Should have appropriate house-keepingand
rodents, pests and vermincontrol.
IV. Separate sampling area foractiveraw material and
exciepients.
V. Every Material stored should be labeledproperly.
Fire Prevention
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23.  Essential part of GMP
 Necessary to achieve the intended results
 Awritten 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
a)For critical process
b) 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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24.  All containers and equipmentshould bear labels
 Differentcolorcoded labels should be used to indicate
the status of a product(for example under
test,approved,passed,rejected)
 The Printing should be done in brightcolors
 The label should contain all the prescribed details
about theproduct.
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