Types of Process validation:

................................... is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.

The Process validation activities can be described in three stages. Stage 1 – Process Design; Stage 2 – Process Qualification; Stage 3 – Continued Process Verification.

Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned protocols. This approach to validation is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences.

............................. is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process. Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do.

.................................. means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems.

............................................. is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process. This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control.

A process of attaining and document in sufficient evidence to give reasonable assurance, given the current state of Science and Technology, that the cleaning process under consideration does, and / or will do, what it propose to do.

Action of proving that any equipment works correctly and leads to the expected result.

The process by, which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application.

................................. is a process of assurance that the specific system, premises or equipment are able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do.

Qualification can be considered to be a part of the validation process

A system must be qualified to operate in a validated process.

.................................... is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.

A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described.

The closeness of test results obtained by that procedure to the true value.

It is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogeneous sample.

It is the ability to assess unequivocally the analyte in the presence of components that may be expected to be present, such as impurities, degradation products, and matrix components.

Its ability to elicit test results that are directly, or by a well-defined mathematical transformation, proportional to the concentration of analyte in samples within a given range.

It’s the measure of its capacity to remain unaffected by small but deliberate variations in procedural parameters listed in the procedure documentation and provides an indication of its suitability during normal usage.

Degree of reproducibility of test results under a variety of conditions.

Equipment should be qualified prior to be brought into routine use to provide documented evidence that the equipment is fit for its intended purpose

Systems and equipment should undergo periodic requalification, as well as requalification after the change.

The benefit of conducting cleaning validation is the identification and correction of potential problems, previously unsuspected which could compromise the safety, efficiency or quality of subsequent batches of product with the equipment.