|
Past,
Present, and Future
Definitions
Perspectives
1900-1962
Activity:
Heard On The Street
From
1962 to the present
New
issues and practices
Quality
by Design
Design
of Experiments
Design
Space
Risk
Assessment
21CFR211
– Multi-media presentation
Consequences
of non-compliance
Personnel
Management
Organization
and personnel
Training
Consultants
and contractors
Standard Operating Procedures
QA
responsibility
Uses
of procedures
Writing,
formatting and guidelines
Revisions
and approval
Review
frequency
Activity:
Writing Procedures
Contamination
Contamination
Control – Multi-media presentation on GMPs
Sources
of contamination
Personal
methods of contamination control
Penicillin
controls
Personal hygiene
Rest
rooms and hand washing
Clothing
to be worn
Clean
room activities
Documentation
Completion,
checking, and correcting documentation
Error
descriptions
Non-compliant
practices
Fraud
and falsification policy
Case
Study: Able Pharmaceuticals
Activity:
Real-time Documentation
Electronic
records - Part 11
Materials
Supplier qualification
Material
specifications, controls and identification
Sampling
Activity:
Bead Sort
Receiving
materials
Non-conforming
materials
Activity:
Design a Product
Packaging
and Labeling
Labels
and labeling
Content
of Labels
Material
examination
Material
controls
Branding
Label
issuance
Packaging
and labeling operations
Expiration
dating
Specifications
Tamper-evident
packaging
Case
study: Tylenol
Activity:
Design A Label
Production
and Process Controls
Common
Controls
Weighing
of materials
Charge-in
of active ingredients
Amount
of active ingredient
Calculation
of yield and values
Equipment
identification
Statistical,
random, or representative sampling
Finished
product and in process testing
Time
limitations on production
On
line testing
Microbiological
contamination control
Reprocessing
Documentation
Activity:
Inspection Detection Subpart F |
Buildings
and Facilities
Design
and construction features
Special
construction considerations
Sufficient
space defined
Product,
equipment, material flow
Designated
and defined spaces with examples
Rationale
for environmental monitoring
Methods
and parameters
Demonstrated
control
Penicillin
contamination
Lighting
Air
systems
Water
Facility
alarms
Waste
Housekeeping
Activity:
Design A Facility
Equipment
Design and Construction
Appropriate
and suitable
Equipment
selection
Blue
prints of process
Control
devices
Equipment
construction materials
Lubricants
Filters
design and specifications
HEPA
Filters
Equipment
use, cleaning and maintenance
Procedures
and training
Levels
of cleaning
Equipment
cleaning logs
Work
orders and repair orders
Log
requirements and exceptions
Activity:
Design A Dream Car
Calibration
Key
elements
Measurement
frequency
Timing,
standards, and procedure
Logs
for due dates
Consultants
and outside firms
Out
of calibration responsibilities
Out
of service
Calibration
documentation
Laboratory
Purpose and Regulations
Subpart
I - Laboratory controls
Establishes
control mechanisms
Specifications,
Sampling, and Testing
Choosing
and using a sampling plan
Testing
and release for distribution
Certificate
of analysis
Analytical
Results
When
an OOS Occurs
Average
laboratory results
Laboratory
investigations
Stability
Testing
Procedural
requirements
Recent
citations
Stability
chamber
Determining
expiration date
Accelerated
stability
Reconstitution
Reserve
Samples
Procedural
requirements
Retention
times
Method
validation
Activity:
Method Validation
The Role
of QA
Definitions
and regulations
Roles
and direct reports
Suppliers
and Contractors Qualification requirements
Outsourcing
and checklist
Approvals
or rejections
Incoming
materials
Materials
inspection and testing
Labeling
specifications
Labeling
control and use
Non-conforming
materials
Investigations
Investigations
and reviews
Structure
of an investigation
Investigation
content
Types
of investigations
QA
Documentation
Product
recall strategy
Depth
of recall
Product
recall classification
Activity:
Design An Audit
Summary
Activity:
GMP Challenge |
