Do you want to know more about Pharma IT's Manufacturing Consulting services?
Pharma IT ensures that all equipment, facilities, utilities and processes are fully compliant
Qualification & Validation of Systems, Equipment, Facilities, and Utilities
Effective support qualifying your system, equipment, facility, and utilities, or validating your production processes
Qualification and Validation of Equipment, Facilities, and Utilities
Effective support qualifying your equipment, facility, and utilities, or validating your production processes
We can help you with every step from risk assessment to PPQ
If you need professional and effective support qualifying your equipment, facility, utilities, or validating your production processes – we’re here to help. Pharma IT’s experienced and dedicated consultants are ready and able to assist you across the full spectrum of qualification and validation activities.
Our team can provide the following Qualification and Validation services, as custom solutions, to best meet your needs
Qualification
Qualifying your System, Equipment, Facility, and Utilities
CQV activities
Preparation and planning qualification and verification activities (DQ, IQ, OQ, PQ, IV, OV, PfV, etc.) to ensure GxP compliance
Deviation, CAPA handling & Change Request (CR)
Writing, approving and reviewing documents (URS, RA, SOPs, P&ID, design documents, components lists, instrument lists, work instructions, protocols, test sheets, reports, etc.)
Commissioning (FAT/SAT)
Decommissioning
Validation
Validating your manufacturing processes
Cleaning & Sterilization Validation (CIP/SIP)
Process Qualification
Process Performance Verfication
Manufacturing automation qualification (DCS/PCS, MES, ERP)
Planning, preparing protocols, test plans (execution of tests, data processing and reporting)
Preparing, reviewing SOPs & work instructions
Preparing and facilitation of process Risk Assessment
... and more!
Our team can provide the following Qualification and Validation services, as custom solutions, to best meet your needs.
Qualification
Qualifying your Equipment, Facility, and Utilities
DQ, IQ, OQ and PQ of equipment, facility and utilities
Planning, protocolling, test execution, data processing and reporting
Training relevant personnel
Deviation and CAPA handling
Writing, approving and reviewing documents (URS, RA, SOPs, work instructions, protocols, test sheets, reports, etc.)
Commissioning (FAT/SAT)
Decommissioning
Validation
Validating your production processes
Cleaning Validation
PPQ/PV
Planning, protocolling, test execution, data processing and reporting
Training relevant personnel
Deviation and CAPA handling
CIP/SIP
Writing, approving and reviewing documents (cleaning strategy, cleaning program, process strategy, SOPs, work instructions, protocols, test sheets, reports, etc.)
Toxicological evaluations
Calculations of MACO and Safety Limits for swab and rinse samples
... and more!
We can assist with all of your quality and compliance needs.
Our goal is to make sure that your organization will achieve and remain in compliance. We strive to increase the quality of your manufacturing processes, to ensure you are able to create safe and high quality drugs for patients.
Rojan Demirtas, Director of Manufacturing
We can assist with all of your quality and compliance needs
Our goal is to make sure that your organization will achieve and remain in compliance. We strive to increase the quality of your manufacturing processes, to ensure you are able to create safe and high quality drugs for patients.
Rojan Demirtas,
Director of Manufacturing
Do you want to know more about our Manufacturing Consulting services?
Pharma IT ensures that all equipment, facilities, utilities and processes are fully compliant