Transcript GMP Orientation Course

Introduction to GMP
CHEE 440
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Objectives
 Acquire
basic knowledge of
Good Manufacturing Practices (GMP)
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What are GMPs ?
Why are they important ?
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History of Food and Drugs Act
 Government
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Authorities
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Canada: Health Canada
Health Products and Food
Branch (HPFB)
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USA: Food & Drug Administration (FDA)
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Europe: EC Directives
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History
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Food and Drugs Act
Food and Drug Regulations
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1900’s- Adulterated Food
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Drugs had to be proven safe
1960’s- Thalidomide
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First purity laws enacted
1930’s- Sulfanilimide
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Division 2 : Good Manufacturing Practices
Drugs had to be proven safe and effective through
clinical trials
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Why are GMPs important?
 Government
 Ensure
quality product
 Reduce
rejects, recalls
 Satisfied
customers
 Maintain
manufacturing consistency
 Company
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requirement
image and reputation
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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
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Claim
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Food and Drugs Act
 Establishment
license
 Site Reference File
 HPFB Inspections
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Production Goals
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Safety
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Identity
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Product is free from contamination
Quality
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Product has correct concentration, potency or therapeutic
activity of active ingredient
Purity
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Product exactly matches the labelling and related documents
Strength
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Product is free of unwanted side effects when used
appropriately by patient
Product meets all standards, expectations; performs as claimed
Product made consistently
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GMP Categories
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Sale
Premises
Equipment
Personnel
Sanitation
Raw Material
Testing
Manufacturing
Control
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Quality Control Department
Packaging Material Testing
Finished Product Testing
Records
Samples
Stability
Sterile Products
Medical Gases
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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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Premises
C.02.004
Equipment C.02.005
 Permits
effective cleaning
 Prevents contamination
 Orderly conditions
 Good state of repair
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Personnel
C.02.006
 Appropriate
education, training and
experience
 Sufficient number of people
 Receive GMP training
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Initial and continuing training as relevant to
job responsibilities
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Sanitation
C.02.007 - .008
 Sanitation
Program to prevent
contamination
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Limit the sources and types of
contamination
» Cleaning procedures for facilities &
equipment
» Pest control
» Environmental monitoring
Documented evidence
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Sanitation
C.02.008
 Hygiene
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Health and eye examinations
Report adverse health conditions
Clothing requirements
» No direct skin contact with product
» Wash hands
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» No jewelry or excessive makeup
No smoking, eating, drinking, chewing, or
keeping of plants in operations areas
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Raw Material Testing C.02.009 .010
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each lot or batch of raw material is tested
three objectives
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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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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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Manufacturing Control
C.02.011
 Written
procedures are established and
followed
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Master formulae, manufacturing order and
packaging order
 Critical
processes are validated
 2nd person verification of activities
 Quarantine system
 Labelling requirements
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Manufacturing Control
C.02.012
 Recall
Programme
 Self-Inspection Programme
 Ensure compliance with
vendors/contractors
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Manufacturing Control
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(cont’d)
Validation: the documented act of demonstrating that
any procedure, process, equipment, material, activity,
or system will consistently lead to the expected results
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TPP 1998 Edition
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
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Quality Control Department
C.02.013 - C.02.015
 Quality
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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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Quality Control Department
C.02.013 - C.02.015
 Quality
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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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Key Quality Terms
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CHANGE CONTROL
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DEVIATION
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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
Planned or unplanned temporary departure from an
approved process, specification or procedure with
the potential to impact product quality
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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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Good Documentation Practices
 Documentation
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must be:
permanent (black or blue ink)
legible, clear, concise
accurate
timely
consistent
complete
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Samples and Stability
 Samples
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Retain samples of each lot of raw material
and finished product for specified period of
time
 Stability
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Establish the length of time in which the
product meets all specifications
Monitor the drug for this period of time
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Sterile Products C.02.029
 Sterile
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Products
Packaged in separate enclosed area by
trained personnel using method to ensure
sterility
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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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