1. Equipment Qualification

We perform full qualification for GMP-critical equipment, including:

User Requirements Specification (URS)
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

Commonly validated equipment includes:

Autoclaves
Sterile filling lines
HVAC systems
Cold storage units
Controlled environment areas

2. Process Validation

We provide end-to-end support for process validation in commercial and clinical manufacturing:

Process Design & Risk Assessment
Protocol Development (PPQ)
Execution & Data Analysis
Continued Process Verification (CPV) Planning

Whether you're launching a new product or scaling up, our team ensures your process meets regulatory requirements.

3. Cleaning Validation

We develop and execute cleaning validation protocols to ensure your equipment is free from carryover contamination:

Worst-case scenario assessments
Swab and rinse sampling strategies
Acceptance criteria development
Analytical method review

4. Computer System Validation (CSV)

Validation of electronic systems used in GxP operations, including:

Validation Plans and Risk Assessments
IQ/OQ/PQ for software and hardware
21 CFR Part 11 and Annex 11 compliance
Audit trail and data integrity testing

Systems include LIMS, QMS software, environmental monitoring, and PLC-controlled equipment.

5. Validation Master Planning

We help you build a strategic, risk-based Validation Master Plan (VMP) that governs all validation activities in your facility.

Document structure & governance
Equipment criticality assessments
Periodic requalification plans
Change control linkage

💡 Why Choose GMPharma?

✔ Experts with 15–25 years of validation experience
✔ Ready-to-use protocol templates
✔ On-site and remote execution support
✔ Fully compliant with TGA, EU GMP, FDA, and ICH Q8–Q10

📥 Need Validation Support?

Whether you're qualifying a cleanroom, validating a new process, or upgrading systems — our team can help you every step of the way.