Professional Documents
Culture Documents
Risk
1
Key Point
Added:
No environmental controls / No monitoring for viable microorganisms
during filling for aseptically filled products.
Revised:
Purified Water (PW) and Water for Injection (WFI) systems not validated
with evidence of problems such as high microbial / endotoxin counts.
replaced by
Water for Injection (WFI) systems not validated with evidence of
problems such as microbial / endotoxin counts not within specifications.
Revised (in italics):
Critical sterilization cycles based on Probability of Survival not validated.
(added)
Rev. Jul-03
Summary of Changes to
Risk Classification of GMP Observations
Changes related to: Sterile Products C.02.029
Risk
Key Point
2
cont
Revised:
No environmental controls / No monitoring for viable microorganisms
during filling. replaced by
Insufficient environmental controls / Insufficient monitoring for viable
microorganisms during filling for aseptically filled products.
Inadequate formation / training of personnel / clothing requirements.
replaced by
Inadequate training of personnel.
Inadequate gowning practices for clean and aseptic areas.
Sanitation / disinfection program incomplete. replaced by
Inadequate sanitation / disinfection program.
No SOPs for media-fills. replaced by
Inadequate procedures for media-fills.
Revised (in italics):
Aqueous-based products not subject to terminal steam sterilisation without
proper justification or approval through the marketing authorization.
(added)
Non-validated time limit between start of manufacturing and sterilization or
filtration. (replaces lapse)
Inadequate SOPs / practices / precautions to minimize contamination or
prevent mix-ups. (removed)
No consideration given to initial bioburden prior to sterilization and no
validated time limit between start of manufacturing and sterilization or
filtration. (removed)
Removed:
Inadequate inspection for particles and defects.
Rev. Jul-03
Added:
Steam used for sterilization not monitored to assure suitable quality and
absence of additives.
Inadequate control on the maximum number of personnel present in clean
and aseptic areas.
Gases used to purge solutions or blanket products not passed through a
sterilizing filter.
Inadequate inspection for particles and defects.