What is qualification and validation

Описание: 1️⃣ What is Qualification?
Qualification is documented evidence that equipment, instruments, utilities, or systems are installed correctly and work as intended.
👉 In simple words:
“Is the equipment ready and capable to be used?”
🔹 Focus of Qualification
Equipment
Instruments
Utilities (HVAC, water system, compressed air)
Computerized systems
🔹 When it is done
Before routine use
After installation
After major modification or relocation
🔹 Types of Qualification
1️⃣ DQ – Design Qualification
Confirms the design meets GMP and user requirements
Example: HPLC specifications meet analytical needs
2️⃣ IQ – Installation Qualification
Confirms equipment is installed as per manufacturer’s specs
Checks:
Utilities
Calibration status
Manuals
Model & serial numbers
3️⃣ OQ – Operational Qualification
Confirms equipment operates within defined limits
Example:
HPLC flow rate accuracy
Oven temperature uniformity
4️⃣ PQ – Performance Qualification
Confirms equipment performs consistently during routine use
Example:
HPLC system suitability over multiple runs
2️⃣ What is Validation?
Validation is documented evidence that a process, method, or system consistently produces results meeting predefined specifications.
👉 In simple words:
“Does the process give correct and reproducible results every time?”
🔹 Focus of Validation
Manufacturing process
Analytical method
Cleaning process
Computerized systems
🔹 When it is done
Before commercial production
Before routine analysis
After major changes
🔹 Types of Validation
1️⃣ Process Validation
Ensures manufacturing process produces consistent quality
Example: Tablet compression produces uniform weight & content
2️⃣ Analytical Method Validation
Ensures test method is suitable for its purpose
Parameters:
Accuracy
Precision
Specificity
Linearity
Robustness
3️⃣ Cleaning Validation
Confirms equipment is cleaned to acceptable residue limits
4️⃣ Computer System Validation (CSV)
Confirms software systems comply with data integrity & GMP


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