Vlidation

VALIDATION: 

VALIDATION

Validation: 

Validation The documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment .

Concept of Validation: 

Concept of Validation

Types of Validation: 

Types of Validation Process Validation Prospective Validation Concurrent Validation Retrospective Process Validation Equipment Validation Cleaning Validation Personnel Validation

Types of Validation: 

Types of Validation Process Validation Process validation is a mean of ensuring and documenting that the processes are capable of producing a finished product of the required quality consistently and should cover all the critical elements of the manufacturing process

Types of Validation: 

Types of Validation Prospective Validation T he validation protocol is executed before the process is put into commercial use Each step should be evaluated on the basis of experience or theoretical considerations A series of experiments should planned and documented fully in an authorised protocol

Types of Validation: 

Types of Validation Concurrent Validation ( certain circumstances ) • previously validated process is being transferred The product is a different strength of a previously validated product the process is not fully under control The number of batches produced are limited Process of manufacturing urgently needed drugs due to shortage

Types of Validation: 

Types of Validation Retrospective Process Validation Historical data are utilized to provide documentary evidence & processes are validated acceptable data from a minimum of ten consecutive batches produced be utilized

Types of Validation: 

Types of Validation Equipment Validation the systems and equipment to be used have been fully validated previously justification for conducting concurrent validation must be documented and the protocol must be approved by the Validation Team

Types of Validation: 

Types of Validation Cleaning Validation The documented act of demonstrating that cleaning procedures for the equipment used in fabricating / packaging will reduce to an acceptable level all residues and to demonstrate that routine cleaning and storage of equipment does not allow microbial proliferation

Types of Validation: 

Types of Validation Personnel Validation Demonstrate that personnel are appropriately qualified, where relevant These include for example: laboratory analysts; personnel following critical procedures; personnel doing data entry in computerized systems; and risk assessors.

Types of Validation: 

Types of Validation Revalidation Processes and procedures - to ensure that they remain capable of achieving the intended results In accordance with a defined schedule Frequency and extent determined using a risk-based approach together with a review of historical data

Types of Validation: 

Types of Validation Revalidation after change After change that could have an effect on the process, procedure, quality of the product and/or the product characteristics. (Considered as part of the change control procedure.) Extent depends on the nature and significance of the change(s) Changes should not adversely affect product quality or process characteristics

Changes requiring revalidation should be defined in the validation plan and may include:: 

Changes requiring revalidation should be defined in the validation plan and may include: changes in starting materials change of starting material manufacturer transfer of processes to a different site changes of primary packaging material changes in the manufacturing process changes in the equipment production area and support system changes appearance of negative quality trends appearance of new findings based on current knowledge support system changes e.g. including physical properties, such as density, viscosity or particle size distribution that may affect the process or product e.g. change of facilities and installations which influence the process e.g. substituting plastic for glass e.g. mixing times or drying temperatures e.g . addition of automatic detection systems, installation of new equipment, major revisions to machinery or apparatus and breakdowns e.g. rearrangement of areas, or a new water treatment method e.g. new technology