Validation of New Process
Process validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Category: Validation
Water Qualification
Water is the most widely used raw material or starting material in the production, processing and formulation of pharmaceutical products. Planned, well-defined, successful and well-documented commissioning…
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…
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…
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…
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…
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…
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…
Process Performance Qualification Protocol/Process Validation Protocol
Process Performance Qualification Protocol Name of Product: Stage: Product Code: Plant: Sr. No. Table of Contents Page No. 1. Purpose 2. Scope 3.…
Validation Master Plan for Pharmaceutical Industry
Author of the document Prepared by Designation: Signature Date: Reviewer of the document for correctness Reviewed by: Designation: Signature: Date: Approver of the document for…
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