Requirement · EU GMP
Demonstrate sampling recovery
Recovery should be demonstrated for sampled contact materials and methods.
EU GMP Annex 15: Qualification and Validation ↗Recovery · Swab Sampling · Rinse Sampling
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Topic
Cleaning Validation
A connected view of process design, qualification and continued control.
10 references ↗Topic
HBEL & PDE
Health-based exposure limits and their role in cross-contamination risk assessment.
5 references ↗Topic
MACO
Translating an exposure assessment into a justified carryover limit.
2 references ↗Topic
Recovery
Understanding what the sampling and analytical procedure can retrieve.
5 references ↗Topic
Swab Sampling
Direct surface sampling, location selection and material compatibility.
5 references ↗Topic
Rinse Sampling
Sampling accessible and enclosed equipment through a justified rinse procedure.
3 references ↗Topic
Worst Case
Selecting representative challenges and recording the limits of that representation.
6 references ↗Topic
Visual Inspection
Making visual cleanliness an explicit, reproducible part of the control strategy.
3 references ↗Topic
Hold Times
The intervals before cleaning and between cleaning and equipment reuse.
2 references ↗Topic
Analytical Methods
Analytical suitability in the context of the residue and the acceptance criterion.
2 references ↗Topic
Acceptance Criteria
Documented decisions about limits, measurement and acceptance.
6 references ↗Topic
Shared Equipment
Connecting product characteristics, equipment and cross-contamination controls.
6 references ↗Topic
Revalidation
Evaluating the effect of change on an established cleaning process.
3 references ↗Topic
Microbial Control
Considering microbial contamination alongside chemical residue risks.
1 references ↗Topic
Detergents
Cleaning-agent selection and the evidence supporting residue removal.
1 references ↗