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