Pharma

How To Know About Validation In Pharma Industry.

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Validation

 

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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