Professional Documents
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2 1b Cleaning Validation
2 1b Cleaning Validation
Cleaning validation
John Startup
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and
.assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda
Validation
Cleaning Validation
Part 3
1.1 – 1.2
1.3 – 1.4
2.1 – 2.2
Training of personnel
3.3, 5.1
Bracketing:
Very similar cleaning procedures for products and processes -
no need for individual validation. “Worst case” may be
acceptable and should be justified.
4.1.4 – 4.1.6
Bracketing:
Representative product - most difficult to clean.
4.1.7 – 4.1.8
4.2.1
6.3 – 6.4
Composition known
Re-sampling:
– not to be done before or during cleaning
9.1.3
9.3.2
Recovery
Recovery
Recovery
Previous product
11.6 – 11.8
11.10 – 11.11
Group session