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
Identification of process variables.
Process Monitoring need for improvement.
Steps involved in Cleaning Validation
- Cleaning process
- Sampling (Rinse & Swab)
- Sample analysis
- 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.