Validation

Analytical Method Validation

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

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.  FC-Validation LifecycleDownload

CVP : Cleaning Validation Protocol

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. Cleaning Validation...

Concurrent Validation

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. Concurrent Validation In concurrent validation,...

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...

Engineering SOP -FAT : Factory Acceptance Test & SAT : Site Acceptance Test

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 siteEstablishing documented evidence that the vendor fabrication process or material...

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...

Process Performance Qualification Protocol/Process Validation Protocol

PV ProtocolDownload Process Performance Qualification Protocol Name of Product: Stage: Product Code: Plant: Sr. No. Table of Contents Page No. 1. Purpose   ...

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