2. Definition
That part of QA which ensures that products are
consistently produced and controlled to the quality
standards as per the specifications.
3. The Early Beginnings
1900’s- house-calls
Home remedies, ointments and “miracle elixirs”
No regulations until 1902
4. Public Involvement
1905 - The Jungle by
Upton Sinclair
Exposure of unsanitary
Meat packing plants.
Increased Public awareness
And involvement
Pure Food and Drug Act
False labeling became illegal
5. A Time line of GMP
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
6. 1941 Initiation of GMP
Sulfathiaziole tablets contaminated with phenobarbital
1941 - 300 people died/injured
FDA to enforce and revise manufacturing and quality
control requirements
1941 - GMP is born
Thalidomide tragedy
Thousands of children born with birth defects due to
adverse drug reactions of morning sickness pill taken by
mothers
Strengthen FDA’s regulations regarding experimentation
on humans and proposed new way how drugs are
approved and regulated
“Proof of efficacy” law
8. Areas to be Covered
General considerations
Personnel
Premises
Equipment
Sanitation
SOP’s
Raw Materials
Self Inspection And Audit
Master Formula Records
Batch Manufacturing Records
9. Areas to be Covered(cont..)
Warehousing Area
Reference Samples
Validation and process validation
Labels And Other Printed Materials
QA
15. Premises
Location
Geography, climate,and economic factors
Neighbours
a) What do they do?
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
17. Premises
Design
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
18. Premises
Design(cont..)
Maximum protection against entry of insects, birds and animals
Specific Areas
1) Production areas
2) Quality control areas
3) Weighing areas
4) Storage areas
5) Ancillary areas
20. Premises
Construction
Measures should be taken to prevent cross-
contamination
Dust control measures (including extraction of dust
and air)
No areas for dust accumulation
Easily cleanable surfaces
Proper air supply
Use of HEPA filter’s
23. Equipments
Equipment shall be
located,designed,construcetd,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) Caliberated
b)Checked
c)labelled
d)Sterilized
27. Standard Operating
Procedure
There shall be written Standard Operating Procedure
for each operation
It include-
a)For Eqipments
b)For sampling
c)For Testing
d)For Process
f)For Packaging
29. Raw Materials
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.
30. Self Inspection And Audit
Regular independent inspection is necessary to
evaluate the manufacturer’s compliance with GMP in
all aspects of manufacturing
Procedure for self inspection shall be documented
indicating
a)Evaluation
b)Conclusion
c)Recommendations for Corrective action
31. Master Formula Records
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) Detaild stepwise processing instructions and the time
taken for each step
vi)Any special precations
vii)Packing details and Specimen labels
32. Batch Manufacturing
Records
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
34. Warehousing Area
Warehousing area should be designed and adapted
to ensure good storage conditions.
Should be Clean,dry and maintained with acceptable
temperature limits.
Should have appropriate house-keeping and
rodents,pests and vermin control.
Seprate sampling area for active raw material and
excipients.
Every Material stored should be labeld properly.
Fire Prevention
36. Reference Samples
Should be taken in sufficient quantity from each lot of
active ingridient to carry out all the tests
These samples should be retained for a period of 3
months after the date of expiry of the last batch
produced from that active ingridient
Samples of raw material should be stored in suitable
container(plastic or glass) as mentioned in the SOP
37. Reference Samples
Samples of finished formulations shall be stored in
the same containers in which the drug has been
actually marketed
39. Validation and process
validation
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 new master formula or method of
prepration 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
41. Labels And Other Printed
Materials
All containers and equipment should bear labels
Different colour coded labels should be used to
indicate the status of a product(for example under
test,approved,passed,rejected)
42. Labels And Other Printed
Materials(cont..)
The Printing should be done in bright colours
The label should contain all the prescribed details
about the product.
44. Quality Assurance
The main objective of the quality assurance is to
ensure the products are of the quality required for
their intended use
Functions-
i)Adequates are made for manufacuring,supply and
the use of correct starting and packing material
ii)Adequate control on starting
material,intermediate,and bulk products.
Iii)Process validation in accordance with established
procedures
45. References
Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug. 2008.
http://www.capitalcentury.com/1906.html
FDA Food and Drug Administration. GMP Combination Handbooks. 31
Aug. 2008. http://images.google.com
WHO Technical Report Series, No. 929, 2005
