What We Offer ?
At Valqpro LLP, we provide complete Validation Documentation and Execution Services tailored for pharmaceutical, biotech, food, and healthcare facilities. Our team prepares and executes validation protocols in accordance with GMP, WHO, US FDA, MHRA, and EU GMP standards, ensuring your systems, processes, and equipment are fully qualified and audit-ready.
Whether you’re commissioning a new system, expanding your facility, or maintaining ongoing compliance, we support every step of your validation lifecycle—from design qualification to requalification, process validation, and cleaning validation.
Design Qualification (DQ)
To verify that the design of a facility, system, or equipment meets intended purpose and GMP requirements.
Design Review.
URS to Design Traceability.
GMP and Compliance Alignment.
Vendor Document Review.
Installation Qualification (IQ)
To confirm that all equipment, instruments, and systems are installed correctly as per manufacturer guidelines and engineering design.
Equipment Model & Serial Number Checks.
Utility Supply Verification.
Calibration & Certificates.
Engineering Drawing Review.
Operational Qualification (OQ)
To ensure that equipment or systems operate as intended across the defined operational ranges.
Functional Testing.
Control Panel & Alarm Verification.
SOP Verification.
Critical Parameter Checks.
Performance Qualification (PQ)
To verify that the system consistently performs according to the predefined specifications under real-world conditions.
Test Run Under Actual Operating Conditions.
Environmental & Process Monitoring.
User Handling Simulation.
Documentation of Routine Use Cases.
Requalification Services
For revalidation after major changes, periodic reviews, or relocation of equipment and systems.
Periodic Revalidation Plan.
Impact Assessment of Changes.
Partial or Full IQ/OQ/PQ Re-execution.
Updated Protocols and Reports.
Process Validation
Demonstrates that a manufacturing process consistently produces a product that meets quality attributes and specifications.
Critical Process Parameter (CPP) Monitoring.
In-process & Final Product Sampling.
Batch Documentation Review.
Protocol Development & Execution.
Statistical Evaluation of Results.
3-Batch or Risk-Based Validation Model.
Cleaning Validation
Ensures that cleaning procedures effectively remove residues, preventing cross-contamination between product batches.
MACO Calculation (Maximum Allowable Carryover).
Swab & Rinse Limit Testing (based on API, Detergent, Bioburden).
Lab Analysis (TOC, HPLC, Microbial).
Acceptance Criteria Setting.
Hold Time Studies.
Regulatory Compliance
WHO TRS
21 CFR Part 211
ICH Q7A
EMA Guidelines