At Qualipharma, we offer commissioning and qualification services in all phases (DQ/IQ/OQ/PQ) for pharmaceutical equipment, facilities, and utilities, as well as instrumentation calibration and computerized systems, from drafting of URS to routine production. Our approach is based on ensuring compliance with GxP and FDA regulations, so that your equipment and facilities operate under the highest quality standards. We handle both the generation of documentation and the necessary executions in each case.
We have the capacity to lead projects of any scale, both nationally and internationally. We provide expert guidance in every phase, from product and process development to the commissioning and startup of new facilities, renovated areas, and equipment, as well as periodic requalifications and calibrations.
PHASE I: Conceptual Engineering PHASE II: Detailed Engineering PHASE III: Construction and Assembly PHASE IV: Startup Our homogeneous process approach, with unified documentation and qualification, ensures consistency across all equipment manufacturers.
This guarantees compliance with the V Model and GAMP5 standards, making it easier for pharmaceutical laboratories to justify their equipment purchases to regulatory agencies.
Equipment manufacturer Optimization in Project Hour Allocation
Qualipharma takes on quality control and internal supervision activities, reducing the operational burden on the manufacturer.
Integration of the Documentation Process
The manufacturer does not need to integrate or generate documentation for other machines within the scope of the project, allowing for savings in direct labor and avoiding non-recurring workload.
Specialized and Experienced Team
Access to a team with experience in top-tier companies, possessing in-depth knowledge of internal complexities, sterile environments, and the ability to adapt to each specific need.
Project-Specific Costs
Cost structure 100% attributable to the project, with competitive hourly rates that generate a positive impact on profitability (P&L) through favorable variations.
Access to Regulatory Compliance Consulting
An updated system in GxP, FDA, ISO 13485, and full CSV compliance under GAMP5 standards and CFR 21 Part 11 Annex 11, backed by the experience of leading companies in the industry.
Unique Value Proposition
Exclusive offer available only through the leading brands in the market.
Improvement in the Service Proposal
We offer the periodic execution of calibrations and requalifications.
End user Substantial Improvement in Project Hour Allocation
We take on quality and internal control activities
Unique Documentation Package
Integrated solution documentation from different participants with a single point of responsibility and a unified Validation Master Plan for all project stakeholders.
Dedicated Documentation and Qualification Management PM
Our PM works alongside the project’s PM, providing valuable expertise in regulations and processes.
Post-Project Hiring Option
The possibility of hiring us for continuous validation services after PQ.
Management of the Annual Validation Plan
Ability to manage and develop an annual validation plan with technical service for all installed equipment.
With Qloud by Qualipharma, you will have your qualification and calibration documentation instantly, without errors. You will have permanent access to your qualification documentation through our client portal and gain full control over your processes.
Qualification of equipment and air systems Our qualifications ensure the proper functioning and maintenance of your equipment, instruments, and facilities. We help you comply with all applicable requirements, maintain optimal performance, and address any deviations that are detected.
Equipment
We carry out preventive maintenance on an annual basis to assess the condition of the equipment, as well as corrective maintenance with original spare parts, providing a fast and effective response.
UTAS – SAS/PASSBOX – Laminar flow and Biological Safety Cabinets – Extraction Cabinets/Fume Hoods – Bag In / Bag Out – Carving Tables – Visual Inspection Tables – Racks – Radiopharmaceutical Cells – Dispensers.
Facilities
Services Compressed Gases
We help you assess the condition of your compressed gas installation according to the ISO 8573 standard, which sets the quality requirements that different compressed gases must meet based on the manufacturing process.
Microbiological Testing
We ensure the microbiological safety and quality of processes. This service includes the evaluation and control of microbial load in equipment, clean rooms, water, air, and products, ensuring compliance with the relevant regulatory standards (GMP, FDA, USP…).
Cross-Contamination Sampling
In accordance with the applicable UNE standards, Qualipharma develops an environmental verification plan, which consists of 3 stages:
CIP/SIP Cleaning Systems
We carry out the qualification of automatic cleaning and sterilization systems (CIP/SIP) by controlling the critical parameters of temperature and pressure in tanks, reactors, skids and other production equipment.
Thermal Mapping Our thermal mapping service during the OQ and PQ phases will allow us to confirm that our equipment is functioning correctly. As part of the qualification, we carry out the calibration of the monitoring and control instruments beforehand and perform temperature distribution tests.
Peace of mind and safety in sterilization processes.
Autoclaves – Depyrogenation tunnels – Drying ovens.
Precise thermal control for the preservation and processing of sensitive products.
Stoves – Refrigerators – Freezers – Climate Chambers – Tanks/Reactors/Fermenters – Thermostatic Baths – Incubation Chambers – Drying Chambers
Critical parameters in all phases of the lyophilization recipe.
Lyophilizers
Suitable thermal conditions during storage and distribution.
Warehouse and Transportation Route Mapping.
Instrumentation Calibration We offer a comprehensive calibration and adjustment service for instrumentation, either at your facilities or in our laboratory, to ensure that all measuring devices and instruments operate with precision.
Mass
Scale – Dynamic Scale – Thermobalance
Temperature – Humidity
Thermometer – Data Logger – Thermohygrometer
Humidity
Pressure – Vacuum
Pressure Probe and Loop – Manometer/Transmitter/Transducer – High Vacuum Probe – Vacuum Gauge
Volume
Single-Channel Pipette – Multi-Channel Pipette – Burette
Time
Stopwatch – Tachometer
Length
Vernier Caliper – Micrometer – Caliper
Particle Counters
We offer you the possibility to calibrate your non-viable particle counters (multi-brand), portable or remote (with or without pump) in our laboratory, with a custom-designed system for counter calibration.
Others
pH Meter – Conductivity Meter – Centrifuge – Stirrer – Refractometer – Durometer – Viscometer – Photometer – Lux Meter – Sampler
Specialized Training Certify your talent in the industry at [Name of the Cube] with our catalog of courses in both in-person and online formats. Discover e-learning by Qualipharma.
Tell us what you need, and our team will find the most suitable solution for your project.
Stay up to date with the latest news in the pharmaceutical industry, regulations, and the innovative solutions we offer at Qualipharma.
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