At N.K. Industries, we understand that precision, compliance, and quality assurance are non-negotiable in the pharmaceutical and packaging industries. That’s why we offer complete DQ (Design Qualification), IQ (Installation Qualification), and OQ (Operational Qualification) support for all the machinery we manufacture and supply.
Whether you are investing in a single vial filling machine or an entire production line, our validation services ensure that your equipment meets the highest GMP, FDA, and EU regulatory standards from day one.
We prepare detailed DQ documentation that verifies your equipment design meets user-defined requirements and regulatory expectations. This includes:
URS (User Requirement Specification) Review
Functional & Technical Specification Conformance
Regulatory Compliance (GMP, FDA, WHO, EU)
Risk Assessment and Material Traceability
Our team ensures your machine is installed correctly and ready for safe operation. IQ documents include:
Site Requirements & Layout Verification
Utility Checks (Electrical, Pneumatic, Water)
Equipment & Instrument Calibration
Installation Checklist & Manufacturer Certificates
We validate the operational reliability and performance of the machine. OQ documentation covers:
Control Logic & Alarm Verification
Performance Testing at Set Parameters
Reproducibility & Function Tests
Test Summary & Approval
All machines manufactured and exported by N.K. Industries are covered under DQ, IQ, and OQ validation support.
Our validation services apply across our complete machinery range, including:
Ampoule & Vial Washing Machines
Bottle Washing Machines
Liquid Filling Machines (syrups, injectables, viscous fluids)
Powder Filling Machines (dry powder, injectable, auger-type)
Dry Syrup Filling & Sealing Machines
Capping Machines (Screw, ROPP, Pick-and-Place, Lug, Flip-Off)
Cup/Cap Placement Machines
Sticker Labeling Machines (vials, ampoules, bottles, jars, boxes)
Shrink Sleeve Applicator Machines
Tablet Counting & Bottle Filling Machines
Blister Packing & Cartoning Machines
With every machine, we provide tailored and audit-ready validation documentation that ensures hassle-free regulatory inspections and internal quality checks.
Achieve regulatory compliance (GMP, FDA, WHO, EU guidelines)
Assure machine performance and reliability
Build a traceable, auditable record of quality
Minimize risks of process failure, contamination, or downtime
Reduce product rejection and revalidation costs
N.K. Industries provides a robust validation package that includes:
Design Qualification (DQ) Protocol & Report
Installation Qualification (IQ) Protocol & Report
Operational Qualification (OQ) Protocol & Report
Calibration Certificates & Material Traceability
FAT & SAT Checklists
SOPs and Equipment User Manuals
Wiring Diagrams, Layout Drawings & P&ID (if applicable)
All documents are delivered in editable formats and can be aligned with your internal quality system or regulatory audit formats.
We have a proven track record of delivering validation support to clients across:
India: Ahmedabad, Mumbai, Pune, Hyderabad, Baddi, Bengaluru, Indore, Chandigarh, Kolkata, etc.
Overseas: USA, Canada, Germany, UK, Saudi Arabia, Egypt, South Africa, Indonesia, Vietnam, UAE, and many more.
Our validation documentation is aligned with global regulatory bodies and audit expectations, ensuring smooth approvals and compliance in any geography.
Take the guesswork out of machine compliance. Let N.K. Industries help you with fully integrated validation documentation from concept to commissioning.