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Program for evaluating the risk of possible cross contamination View project
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About Gedeon Richter
Now the Richter Group has 7 subsidiaries and 29 repr. offices.
About Gedeon Richter
Disclaimer
Revision of EU GMP
Chapters 3 (Premises
and equipments)
and 5 (Production)
simultaneously
How to handle
risk of cross
contamination?
technical guide
Risk-MAPP classification
Mix-ups
Retention cleaning validation
Mechanical transfer
Air transfer
Relevance of EU GMP
Chapters 3. and 5.
Operational control measures
Risk Identification :
E.g. brain storming
Risk ranking:
E.g. FMEA engineering aspects
Scoring by Probability, Severity, Detectability
(being hidden!)
Program: Report part 5 - FMEA
Risk ranking:
Probability
Probability
Score
Event in connection with batches Event in general
10 One or more in a batch One or more daily
7 One or more in 50 batches One or more monthly
5 One or more in 600 batches One or more annually
3 Once in more then 600 batches Once per 1-5 years
Once during more then five
1 -
years time
Program: Report part 5 - FMEA
Severility
Score
PDE (g/nap) Event in general
Critical serious injury, death, irreversible
10 <10
effects
7 10 -100 Major side effects, birth defects
5 1 00 1 000 reversible effects
3 1 000 10 000 Minor irritation, mild reversible effects
1 10 000 100 000 There is no appreciable effect
Program: Report part 5 - FMEA
Score Imperceptibility
Risk filtering:
Classification - criticality
M factor
Batches
C factor
E factor
time (h)
BS (kg)
in 2016
Vulner.
Prod.
Proc.
MDD PDE
Risk
No.
API P
mg/day mg/day