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Monday, January 10, 2022

What is difference between Qualification and Validation Change Managmet and Deviation Control during Validation activities

As per the WHO Guidelines mentione that Both terms are same but qualification is use for equipments and facility, utilities and Validation term is used for System and All sorts of Procedure and Process and qualification is a part of validation.

Same approach principles are applied for both terms or activities. 

Both activities are required to be taken in validation master plan and through protocols and Standard operating procedures.

Who Guidelines further mention that during validation activities one must make use of Statistical calculations of data gathered from evaluation of process syetm ect.

Before validation all qualification activities should be completed.

All SOPs of equipment and operations and maintenance cleaning and calibration should be made ready during qualification.

Operators and supervisor should be trained before validation activities.

Qualification activities are required to be systematic approach to ascertain the required predetermined results up on operation of the equipment.

WHO guidelines US FDA guidelines mention that during validation activity, any 

change required to be done as per the SOP for change control, it should be managed through Change control further one should also consider any previous changes done. It must be evaluated for the need of the requalification and revalidation after the implementation of the changes. An action plan is required for monitoring the same.

Process should describe actions taken and extent of validation or qualification to be done.

Deviations occurring during validation process must be handled through Deviation management system. Investigations and CAPA are required to be initiated and implemented.

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