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Wednesday, April 20, 2011

Terms used in pharma validations and their definitions

Process validation terminology and definitions

Capability of a process: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms. (ISO 9000:2005)

Commercial manufacturing process: The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). the term commercial manufacturing process does not include clinical trial or treatment IND material.

Concurrent release: Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the lot release criteria established in the protocol, but before the entire study protocol has been executed.

Continued process verification: Assuring that during routine production the process remains in a state of control.

Performance indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process or system, also known as performance metrics in some regions. (ICH Q10)

Process design: Defining the commercial manufacturing process based on knowledge gained through development and scale-up activities.

Process qualification: Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing.

See here. Process validation

Quality: The degree to which a set of inherent properties of a product, system, or process fulfils requirements. (ICH Q9)

State of control: A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (ICH Q10)
FDA guideline
Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical prodct to foreign contries

Process Validation Series    

Process validation aspects of Analytical Methodology.

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations

Details on pharma guideline. are here at who guideline blogspot com(

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