• Ms. Shivani Shirbhate
• Mr. Ujjawal Bhose

Abstract: Equipment validation is a critical process ensuring that instruments function as intended, yielding expected results. Design Qualification (DQ) verifies the suitability of the proposed design for its intended purpose, while Installation Qualification (IQ) confirms compliance with approved design and manufacturer recommendations upon installation or modification. Operational Qualification (OQ) tests equipment performance across anticipated operating ranges, and Performance Qualification (PQ) assesses effective and reproducible performance based on approved methods and specifications. Verification Qualification (VQ) ensures ongoing alignment with user requirements, Safety Qualification (SQ) validates compliance with safety standards, and Maintenance Qualification (MQ) verifies the suitability of proposed maintenance programs. Re-Qualification (RQ) confirms ongoing satisfactory performance, necessitated by factors like relocation or aging. This comprehensive validation process safeguards against deviations, ensuring equipment reliability and product quality across industries.

Key Words: Validation, Calibration, Accuracy, Precision, Traceability, Installation, Performance, Qualification, Uncertainty, Resolution, Sensitivity.

"Equipment Validation and Calibration in Pharma: Systematic Review with An Industrial Approach", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.b302-b311, June-2024, Available :http://www.jetir.org/papers/JETIR2406140.pdf

"Equipment Validation and Calibration in Pharma: Systematic Review with An Industrial Approach", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppb302-b311, June-2024, Available at : http://www.jetir.org/papers/JETIR2406140.pdf