𝗪𝗵𝗮𝘁 𝗶𝘀 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻?

Validation is the documented process of proving that a system, process, or equipment consistently produces results that meet predefined specifications and quality attributes. It ensures that products or processes work as intended, complying with regulatory requirements.

In pharmaceutical industries main type of validations are:

• Process Validation
• Equipment Validation
• Computer System Validation (CSV)
• Cleaning Validation
• Analytical Method Validation
• Utility/System Validation
• Sterilization Validation

• Process Validation
  Ensures manufacturing processes produce consistent and reliable products.
  *Process Design
  *Process Qualification
  *Installation Qualification (IQ)
  *Operational Qualification (OQ)
  *Performance Qualification (PQ)
  *Continued Process Verification (CPV)
• Equipment Validation
  Verifies that equipment operates correctly and produces accurate results.
  The steps of equipment validation are:
  *User Requirement Specification (URS)
  *Design Qualification (DQ)
  *Factory Acceptance Testing (FAT)
  *Site Acceptance Testing (SAT)
  *Installation Qualification (IQ*)
  *Operational Qualification (OQ)
  *Performance Qualification (PQ)
  *Revalidation (Periodic or After Changes)
• Computer System Validation
  Confirms that computerized systems function as expected and comply with regulatory standards like FDA’s 21 CFR Part 11.
  The steps of Computer System Validation (CSV) are:
  *System Requirements Specification (SRS)
  *Risk Assessment
  *Validation Plan
  *Vendor Audit (if applicable)
  *Installation Qualification (IQ)
  *Operational Qualification (OQ)
  *Performance Qualification (PQ)
  *Traceability Matrix
  *Data Migration Testing (if applicable)
  *User Acceptance Testing (UAT)
  *Validation Report
  *System Release
  *Change Control and Periodic Review
• Cleaning Validation
  Cleaning Validation is a documented process that ensures cleaning procedures effectively remove residues of the previous product, cleaning agents.
  *Develop a Cleaning Process
  *Define Acceptance Criteria
  *Risk Assessment
  *Selection of Sampling Methods
  *Perform Cleaning Trials
  *Analytical Method Validation
  *Document and Report Results
  *Monitoring and Revalidation

• Analytical Method Validation
  Analytical Method Validation is the process of proving that an analytical method is suitable for its intended purpose by assessing its accuracy, precision, specificity, sensitivity, and reproducibility to ensure reliable results in detecting and quantifying residues or contaminants.
  
• Utility/System Validation
  Water system validation Phase 1, Phase 2, Phase 3
  
• Sterilization Validation
  Autoclave validation