Validation of New Process

Process validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific…

Water Qualification

Water is the most widely used raw material or starting material in the production, processing and…

Analytical Method Validation

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable…

Validation Lifecycle

Validation lifecycle approach is linking product and process development, validation of the commercial manufacturing process and…

CVP : Cleaning Validation Protocol

Adequate cleaning procedures play an important role in preventing contamination & cross-contamination. Validation of Cleaning Methods…

Concurrent Validation

Description : Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior…

CEHT (Clean Equipment Hold Time Study)

Why is the CEHT important for the control of a cleaning process? Essentially the reason is…

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…

MACO Calculation

Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data…

Process Performance Qualification Protocol/Process Validation Protocol

Process Performance Qualification Protocol Name of Product: Stage: Product Code: Plant: Sr. No. Table of Contents…