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Validation
Validation
Ensuring Compliance, Efficiency & Quality
At Isha’s GMP, we provide end-to-end validation solutions to help pharmaceutical, biotech, and medical device companies meet regulatory
Our Validation Services:
Equipment Validation
- Commissioning & Qualification for process equipment
- Validation of bioreactors, fermentors, sterilizers, filling lines, packaging equipment, and more
- Cleaning & sterilization validation (CIP/SIP)
Process Validation
- Analytical Methods Validation
- Aseptic Process Validation
- Cleaning Validation & Cross-Contamination Studies
- Shipping Validation
Product Validation
- Verification of product specifications & regulatory compliance
- Parenterals, liquids, suspensions, tablets, ointments, powders
QC & Microbiology Method Validation
- Precision, accuracy, range & linearity
- Limit of Detection & Quantification
- Specificity & robustness
Cleaning Validation
- Prevention of contamination & cross-contamination
- Total Organic Carbon (TOC) testing for drug residue & detergent removal
- Rapid detection of contamination to salvage production runs
Facilities & Utility Qualification
- Design & validation of HVAC, water, sterilization, dust-control systems
- Factory Acceptance Testing (FAT) & Site Acceptance Testing (SAT)
- Cleanroom qualification & controlled area validation
Re-Validation Services
- For equipment relocation, repairs, modifications, & regulatory updates
- GLP-accredited verification for ongoing compliance
Why Choose Isha’s GMP for Validation?
- Global regulatory expertise with cGMP, FDA, EMA, & MHRA compliance
- On-site & remote validation support
- Comprehensive validation documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV)
- Cost-effective, time-efficient solutions
Ensure compliance & efficiency with Isha’s GMP Validation Services. Contact us today!