Validation and Qualification are critical components in ensuring that pharmaceutical manufacturing processes, equipment, and systems perform consistently and reliably, delivering products that meet predefined quality standards. At Incredible Pharmaceutical Pvt. Ltd., we offer comprehensive validation and qualification services tailored to meet the stringent requirements of USFDA, WHO, GMP, cGMP, and ISO regulatory guidelines.

Our services cover a wide range of industries including pharmaceuticals, biotechnology, healthcare, automotive, food processing, and chemical sectors. With a dedicated team of experts and advanced validation tools, we ensure your facility, processes, and equipment remain compliant, efficient, and audit-ready.

What is Validation & Qualification?

• Validation is the documented act of proving that any procedure, process, or activity will consistently lead to the expected results.

• Qualification is the process of ensuring that systems and equipment are properly installed, operate correctly, and perform according to specified criteria.

Together, these processes establish documented evidence that equipment, utilities, and systems are fit for their intended purpose and remain in a state of control throughout their lifecycle.

Our Validation & Qualification Services Include:

✅ Installation Qualification (IQ)
Verifying that equipment and systems are installed in accordance with manufacturer specifications and design requirements.

✅ Operational Qualification (OQ)
Testing to ensure systems and equipment operate correctly under all specified operating conditions.

✅ Performance Qualification (PQ)
Confirming that the system consistently performs according to specifications in the actual production environment.

✅ HVAC System Qualification
Validation of Heating, Ventilation, and Air Conditioning systems to ensure cleanroom compliance with temperature, humidity, pressure, and air cleanliness parameters.

✅ RO & Purified Water System Qualification
Verification and validation of water purification systems used in pharmaceutical processes, ensuring microbial and chemical quality standards are met.

✅ Compressed Air & Nitrogen System Validation
Ensuring the quality and purity of compressed gases used in cleanroom environments and manufacturing processes.

✅ Cleanroom Qualification
Testing for particle counts, airflow, temperature, humidity, and differential pressure to validate cleanroom performance.

✅ Equipment Qualification
Full qualification of production, packaging, and laboratory equipment to ensure regulatory compliance.

Why Choose Incredible Pharmaceutical Pvt. Ltd.?

At Incredible Pharmaceutical Pvt. Ltd., our validation and qualification services are grounded in global regulatory frameworks. We provide a structured, risk-based approach, delivering detailed protocols and reports backed by robust data and analysis. Our professionals follow a lifecycle validation approach to ensure:

• Consistent product quality

• Reduced risk of process failure

• Enhanced operational efficiency

• Faster regulatory approvals

• Strong audit and inspection readiness

What Sets Us Apart

• ???? Experienced Team – Led by industry experts and auditors with over a decade of experience in cGMP and ISO.

• ???? Data-Driven Protocols – Detailed validation documents with traceable evidence, deviation handling, and corrective actions.

• ???? NABL-Approved Equipment – All tests conducted using calibrated, certified instruments for accurate results.

• ???? Customized Solutions – Tailored protocols and execution plans designed specifically for your facility and systems.

• ???? Multi-Industry Expertise – Serving clients across pharmaceuticals, biotechnology, food, chemicals, and more.

Industries We Serve

• Pharmaceutical & Biotech

• Healthcare & Medical Devices

• Automotive Manufacturing

• Food & Beverage

• Chemical & Petrochemical

• Power & Utility Plants