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Difference between Qualification and Validation

Qualification and Validation are two familiar words in Pharmaceutical.


Qualification: The act of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and comply with specified requirements. The process used to demonstrate the ability to fulfill specified requirements. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.


Validation: A documented objective evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications.

What is the difference between Qualification and Validation?
  • To perform a manufacturing process we need personnel, equipment, systems or software. These need to be qualified and then, we need to validate the process. Therefore, Qualification is directly related to equipment, systems or software and Validation is directly related to the process.

What is Qualification?
  • The act of planning, carrying out and recording the results of tests which is performed on equipment to confirm its working capabilities and to display that it will perform routinely as intended use and against predefined specification or Acceptance criteria which is mentioned in Supplier’s recommendation / Design specification/Manual/ Supplier’s documents / Guidelines etc.
  • Qualification shall be performed or related to Equipments, Instruments, Facility and Area before use.
  • Qualification has various stages like User Requirement specification, Factory Acceptance test (FAT), Site Acceptance test (SAT), Design Qualification, Installation qualification, Operational qualification and performance Qualification.
  • Qualification shall be performed for all New / Existing Equipment, Facility, System and Instruments by the user with the help of Manufacturer / Supplier of the equipment, instrument, system and facility or 3rd party along with designated personnel from Engineering and other team members.
  • For a manufacturing process we need personnel, equipments, Instruments, Facilities, Area, systems or software which need to qualified First and then we need to validate the process.
  • Critical and Non Critical Equipments, Instruments, Facility and systems requalification shall be performed after every 1 year to 7 years from the date of Qualification.
  • One batch shall be taken for Performance Qualification in case of Qualification of manufacturing equipment


What is Validation?
  • Validation is the process of establishing documentary evidence of the consistency of any process or System & it is the collection and evaluation of data from the process design stage which establishes scientific evidence that a process is capable of consistently delivering quality product.
  • Validation shall be performed for the manufacturing Process.
  • Process validation activities categorized in three stages, 
            Stage 1 : Process Design
            Stage 2 : Process Qualification 
            Stage 3 : Continued Process Verification
  • Validation shall be perform to identify the Risk or Worst Case assessment which is involved in the process.
  • For deep study & to understand the system the process validation is required.
  • Validation shall be performed for Water system, cleaning of equipment, manufacturing process, HVAC System, analytical method, computer system and water system etc.
  • For manufacturing process validation three consecutive batches shall be taken.
  • Periodic re-validation shall be done after every five years with one batch in line with process qualification requirement.

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