Cleaning validation
GMP & Guidelines
CEHT (Clean Equipment Hold Time Study)
Why is the CEHT important for the control of a cleaning process?
Essentially the reason is that nothing stays clean forever. It should be realized that recontamination of the equipment may be an event-related...
GMP & Guidelines
MACO Calculation
Maximum Allowable Carryover (MACO) shall be
calculated based upon theses three criteria.
Using Health Based Data
Based on Therapeutic
Daily Dose (TDD)
Based on LD50
Acceptance Criteria using Health Based Data
CalculateADE (Acceptable Daily Exposure)
according to following equation & use the...
Pharma Industry Guidelines
Cleaning Validation in Pharmaceutical Industry
“It is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing or manufacturing of medicinal products”
It is based on few principles that are listed below:
(B) Selecting worst...