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Aseptic Process Validation Irish Medicine Board
Aseptic Process Validation Irish Medicine Board
Aseptic Process Validation Irish Medicine Board
Aseptic Process
Validation
Gerard Sheridan,
Inspector
• Guidance
• Best Practices
• Common Deficiencies
Slide 2
Aseptic Process Validation
Process Simulation
(Media Fill)
?
Date Insert on Slide 3
Master Slide
• A chain of linked activities
Slide 4
Guidance
Annex 1
Slide 5
Guidance
Annex 1
Slide 6
Guidance
Annex 1
Slide 7
Guidance
Annex 1
Slide 8
Guidance
Slide 9
Guidance
PI 007
General Guidance
• Where filling takes place over extended periods, i.e. longer than
24 hours, the process simulation test should extend over the
whole of the standard filling period. In order to prevent
excessively high numbers of units being filled it is usually
acceptable to just run the machine for a reasonable time, if the
validity of the simulation is not diminished by this procedure.
Slide 10
Guidance
PI 007
• Liquid Products
• Vial Products
• Sterile Products in Plastic Containers
• Ampoule Products
• Suspension Products
Slide 11
Guidance
PI 007
Continued :
Slide 12
Guidance
PI 007
Slide 13
Guidance
PI 007
Other Requirements
• Incubation Conditions
• Test Frequency
• Interpretation of Data
Slide 14
Guidance
PI 007
Other Requirements
• Intervention Monitoring
• Essential to include the various interventions known to occur
during normal production runs, e.g. :
repair or replacement of needles / tubing,
replacement of on-line filters,
duration of stops on the line,
filling and manipulation of stoppers etc.
Slide 15
Guidance
PI 007
Slide 16
Guidance
PI 007
• Staff Training
• Container/Closure Sterilisation
Slide 17
Guidance
PI 007
Continued :
• Disinfection
• Filter Validation
• Vent Filters
• Sterility Test
Slide 18
Guidance
PI 007
• Staff Training
• Training encompasses:
basic microbiology,
good manufacturing practice principles,
hygiene (disinfection and sanitisation),
aseptic connections,
gowning procedures.
Slide 19
Guidance
PI 007
• Container/Closure Sterilisation
Slide 20
Guidance
PI 007
• Disinfection
• Filter Validation
Slide 21
Guidance
PI 007
• Vent Filters
Slide 22
Guidance
PI 007
• Sterility Test
However;
Annex 1
• The sterility test applied to the finished product should only
be regarded as the last in a series of control measures by
which sterility is assured. The test should be validated for
the product(s) concerned
Slide 23
Best Practice
Sterility by Design ?
• Proactive approach
• Process mapping
• All inputs with sterility impact
• Intervention mapping
• Updated based on real experience
Slide 24
An approach
Slide 25
Deficiencies
Slide 26
Deficiencies
SOP 123 did not indicate that vials were to be re-inverted after
the seven day incubation period.
Slide 27
Deficiencies
Media fills did not proactively take into account the various
interventions known to occur during normal production, as well
as worst case situations.
Slide 28
Deficiencies
Slide 29
Deficiencies
Slide 30
Deficiencies
Slide 31
Questions
Slide 32