Qualification & Validation

Qualification & Validation: Ensuring Regulatory Excellence

In pharmaceutical manufacturing, validation is a critical pillar of quality assurance, receiving special emphasis from regulatory bodies like the FDA, EMA, and WHO. Our technical experts deliver comprehensive validation services aligned with current regulations and evolving industry expectations.

Qualification: Foundation for Compliance

Qualification of systems and equipment forms the essential first step in the validation lifecycle. Our rigorous approach includes:

Design Qualification (DQ): Verifying that designs meet regulatory and operational requirements.
Installation Qualification (IQ): Documenting proper installation per specifications.
Operational Qualification (OQ): Testing equipment performance under operational ranges.
Performance Qualification (PQ): Confirming consistent performance under actual conditions.

Qualification Scope

In entirety, the qualification service involves the following steps for protocols and testing:

User Requirement Specification (URS) and/or Technical Specifications (T.S) drafting for the client
Agreeing on Design Review (DR) or Design Qualification (DQ) with the vendors
Factory Acceptance Tests (FAT) – Protocol and Testing
IQ, OQ, and PQ – Protocols and Testing
Process Qualification

Validation

A documented evidence for robustness and reliability, the Validation service proves a high-degree of assurance to determine the consistency of a system, equipment or process. As Lotus Group recognises that validating system components is not one-size-fits-all, we offer customized Validation services as per the client’s requirements.
We specialise in conducting on-site Clean Room Validation regularly as per the BS EN ISO14644, PIC/s, WHO, ISPE and FDA standards for research and production pharmaceutical facilities, including hospitals, laboratories: on following design conditions.

Our Clean Room Validation Services include but not limited to,

Air Flow Rates
Air Change Per Hour (ACPH)
Airborne Particulate Cleanliness Counts
HEPA Filter Integrity Leak Testing– DOP Method
Differential Pressure Measurements
Magnehelic Pressure Gauge Calibration
Temperature, Humidity, Light and Noise Level Readings
Recovery Performance Testing
Airflow Visualization Tests supported by Video and Written Reports
Airflow Balancing and Remedial Works
Complete documentation as per cGMP requirements

About

“IPMS Engineers Private Limited” is a newly formed entity with a strategy to capitalize on the enormous developments taking place within India and related opportunities in EPCM (Engineering, Procurement and Construction Management) by majorly focusing on Pharmaceutical and Chemicals sector.

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Phone

+91 7045388568

Email

mktg@ipms-engg.com

Address

IPMS Engineers Private Limited Unit No. 301/C, 3rd Floor, Wifi Park IT Premises Co. Society Ltd, Plot No. B-3., Wagle Estate, Thane (W) Pin - 400604, Maharashtra, India.