Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it...
Validation lifecycle approach is linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
Adequate cleaning procedures play an important role in preventing contamination & cross-contamination. Validation of Cleaning Methods provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for the intended use.
Description: Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior to approval of batches of complete validation package based on data of individual batch.
In concurrent validation,...
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...
Factory Acceptance Test (FAT)
Inspection and static
&/or dynamic testing of system or major system component to support the
qualification of an equipment/system conducted & documented at a supplier
evidence that the vendor fabrication process or material...
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...