How To Know About Validation In Pharma Industry.

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Introduction of Validation

  • We are discussing Validation process in the pharma industry.


  • Validation is the process of establishing documentary evidence.


  • Validation provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.


  • It is demonstrating that a procedure, process or activity carried out in testing.


  • And then production maintains the desired level of compliance at all stages.


  • The validation is involved in four types of processes, those are


Methods Of Validation Process


  • Analytical method validation


  • Equipment validation


  • Process validation


  • Cleaning validation


Steps involved in Analytical Method Validation

  • Drug design
  • Drug development
  • Method validation
  • Drug approval process by regulatory agencies
  • Analytical procedure development
  • System suitability of RP-HPLC method and process
  • Derivation of detection
  • Specification development
  • Evaluation and characterization studies
  • Stability studies and method development
  • Standardization / Optimization
  • Formulated product development




Steps involved in Equipment Validation

  • Design and development of equipment system or product.
  • Installation qualification
  • Operational qualification
  • Process performance qualification
  • Change control




Steps involved in Process Validation

Stage 1:

            Identification of process variables.

Control Strategy.

Stage 2:

            Process Qualification.

Stage 3:

            Process Monitoring need for improvement.

Process design.

Steps involved in Cleaning Validation

  • Manufacturing
  • Cleaning process
  • Sampling (Rinse & Swab)
  • Sample analysis
  • Results
  • Validated (Yes or No)



Uses of Validation


These validations are used for different types of methods, some of them are


  • We can calculate the accurate values in this validation process.


  • By using this validation, we can find the precision values.


  • The validation process is used to specify the products.


  • It is used to detect the limit of product.


  • We can calculate the limit of quantitation.


  • By using this validation process, we can fix the linearity and range of the product.


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