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 and Validation of Equipment, Facilities, and Utilities
Effective support qualifying your 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 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!
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.
Laith Muala, Director of Manufacturing
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.
Laith Muala
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