3. History of Food and Drugs Act
Government Authorities
Canada: Health Canada
Health Products and Food
Branch (HPFB)
USA: Food & Drug Administration (FDA)
Europe: EC Directives
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4. History
Food and Drugs Act
Food and Drug Regulations
Division 2 : Good Manufacturing Practices
1900’s- Adulterated Food
First purity laws enacted
1930’s- Sulfanilimide
Drugs had to be proven safe
1960’s- Thalidomide
Drugs had to be proven safe and effective through
clinical trials
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5. Why are GMPs important?
Government requirement
Ensure quality product
Reduce rejects, recalls
Satisfied customers
Maintain manufacturing consistency
Company image and reputation
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6. Drugs
HPFB Definition: Any substance or
mixture of substances manufactured, sold or
represented for use in
a) the diagnosis, treatment, mitigation or prevention of a
disease, a disorder, an abnormal physical state or the
symptoms thereof in humans or animals
b) restoring, correcting or modifying organic functions in
humans or animals
c) “disinfection” in premises in which food is manufactured,
prepared or kept
DIN
Label Claim
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7. Food and Drugs Act
Establishment license
Site Reference File
HPFB Inspections
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8. Production Goals
Safety
Product is free of unwanted side effects when used
appropriately by patient
Identity
Product exactly matches the labelling and related documents
Strength
Product has correct concentration, potency or therapeutic
activity of active ingredient
Purity
Product is free from contamination
Quality
Product meets all standards, expectations; performs as claimed
Product made consistently
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10. Sale C.02.003
No distributor … and no importer shall
sell a drug unless it has been
fabricated, packaged/labeled, tested,
and stored in accordance with the
requirements of this Division
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13. Sanitation
C.02.007 - .008
Sanitation Program to prevent
contamination
Limit the sources and types of
contamination
» Cleaning procedures for facilities &
equipment
» Pest control
» Environmental monitoring
Documented evidence
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14. Sanitation
C.02.008
Hygiene
Health and eye examinations
Report adverse health conditions
Clothing requirements
» No direct skin contact with product
» Wash hands
» No jewelry or excessive makeup
No smoking, eating, drinking, chewing, or
keeping of plants in operations areas
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15. Raw Material Testing C.02.009
- .010
each lot or batch of raw material is tested
three objectives
confirm the identity of the raw materials
provide assurance that quality of the drug in
dosage form will not be altered by raw material
defects
assure that raw materials have the characteristics
that will provide the desired quantity or yield in
manufacturing process
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16. Raw Material, Packaging Material
and Finished Product Testing
Samples of incoming materials are
collected and tested before use
Approved test methods and
specifications are used
Results must conform to specifications
for release for use or sale
Transportation and storage records
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17. Manufacturing Control
C.02.011
Written procedures are established and
followed
Master formulae, manufacturing order and
packaging order
Critical processes are validated
2nd person verification of activities
Quarantine system
Labelling requirements
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19. Manufacturing Control
(cont’d)
Validation: the documented act of demonstrating
that any procedure, process, equipment, material,
activity, or system will consistently lead to the
expected results
»
TPP 1998 Edition
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
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20. Quality Control Department
C.02.013 - C.02.015
Quality Control Responsibilities
Testing of bulk components prior to use by
production
Testing of finished product prior to release
for sale
Stability program (in association with QA)
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21. Quality Control Department
C.02.013 - C.02.015
Quality Assurance Responsibilities
Ensure GMP compliance
Review batch records, labels
Release product, based on QC test results
Authorize all master documents and SOPs
Training, auditing
Customer complaints
Recall
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22. Key Quality Terms
CHANGE CONTROL
written procedure that describes the action to be
taken if a change is proposed to facilities, etc. used
in fabrication, packaging, and testing of drugs or
any change that may affect quality or support
system operation
DEVIATION
Planned or unplanned temporary departure from an
approved process, specification or procedure with
the potential to impact product quality
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23. Records
C.02.020 - C.02.024
Document all GMP activities
Use Good Documentation Practices
(GDP)
Records must be readily available
Needed to prove activities were
done
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25. Samples and Stability
Samples
Retain samples of each lot of raw material
and finished product for specified period of
time
Stability
Establish the length of time in which the
product meets all specifications
Monitor the drug for this period of time
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26. Sterile Products C.02.029
Sterile Products
Packaged in separate enclosed area by
trained personnel using method to ensure
sterility
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27. Summary
Pharmaceutical Industry is regulated by
GMPs
Good Manufacturing Practices must be
followed
GMPs ensure drug products are safe,
pure and effective.
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