Do you need assistance with your daily operations in API manufacturing aseptic processes?
Reach out today to learn more about how our team can help you!
Operational Readiness and Manufacturing Support
Support of daily operations in API manufacturing aseptic processes,
filling, CIP/SIP finish products, labelling & packaging, warehouse management
Production, Environmental Monitoring, Labeling, and Packaging Support
Professional assistance for your daily production, labeling & packaging needs
The Pharma IT team is ready to assist you with daily operations in API manufacturing aseptic processes
Our experienced consultants know how to work in a cGMP environment. We offer a wide array of assistance, boast a strong quality mindset, and operate efficiently in high pressure working environments.
The Pharma IT team is ready to assist you with production, labeling & packaging support.
Our highly experienced consultants know how to work in a cGMP environment. We offer a wide array of assistance, boast a strong quality mindset, and operate efficiently in high pressure working environments.
Our consultants can provide the following services:
- Support daily operations in:
- Aseptic processing
- Grade C area
- Grade D area
- Gap analysis of processes and procedures
- Optimization of process and procedures
- Handling deviations, CAPAs and Change controls
- Stakeholder management
- Writing, reviewing and updating GMP-documentation and SOPs
- Assistance during inspections and audits
Our consultants can provide the following services:
- Support all types of production from CNC to sterile environments
- Production, labeling and packaging support including securing daily deliveries
- Review of batch documentation
- Primary-, secondary- and tertiary packaging
- Serialisation
- Managing deviations, including dialogues with QA about defining a deviation
- Handling CAPAs and cases of change controls
- Writing, reviewing and updating SOPs and other types of GMP-documentation
- Environmental monitoring
- Inspection of the authorities and Audits
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 need assistance with your production, packaging, or labeling processes?
Reach out today to learn more about how our team can help you!