Validation

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. FC-ValidationDownload

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

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   ...

VALIDATION OF STERILE PACKAGE INTEGRITY 1

Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may be validated indirectly (e.g., using methods for detecting physical...

HVAC SYSTEM VALIDATION TESTS

AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and placed in front of the AHU. The distribution of smoke is observed. It should be uniform.   AIR...

ANALYTICAL INSTRUMENT QUALIFICATION (AIQ) 1

AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. PHASES OF QUALIFICATION ...

Recent posts

Popular categories