Are you interested in learning more about our Manufacturing Consulting services?
Pharma IT ensures your manufacturing processes reach and remain in compliance
Quality and Compliance in Manufacturing
Ensuring life science companies achieve and remain in compliance
Quality and Compliance in Manufacturing
Ensuring life science companies achieve and remain in compliance
We ensure that your manufacturing processes are complaint
Pharma IT has an experienced team of consultants ready to assist life science companies to achieve and stay in compliance. Our team remains up-to-date on the latest legislation to create effective solutions that drive value for your company, while meeting the requirements set by regulatory authorities.
We ensure that your manufacturing processes are complaint
Pharma IT has an experienced team of consultants ready to assist life science companies to achieve and stay in compliance. Our team remains up-to-date on the latest legislation to create effective solutions that drive value for your company, while meeting the requirements set by regulatory authorities.
Our expertise enables us to support you with QA, QC, and QP
We cooperate closely with our clients and across relevant departments to ensure that all quality related activities are carried out effectively and in compliance with cGMP. To this end, we can support you in the following areas:
- Quality Assurance (QA) of manufacturing activities, batch release and QC documentation.
- Ensuring the batch has been manufactured and tested in accordance with accordance with GMP regulations, quality agreements and Marketing Authorizations.
- Quality Assurance (QA) of Facility & Equipment.
- Quality Assurance (QA) of Qualification & Validation activities (projects).
- QMS update and maintenance.
- Change control handling and quality documentation approval (SOPs, qualifications, validations, CAPA’s and deviations).
- Training: ensure that initial and ongoing training programs are developed, implemented and maintained, and that employees receive regular training.
- Internal/external audits and regulatory inspections.
- QC support within raw materials, water systems and production and packaging materials.
- Analytical test results review and approval.
- Release incoming materials and WFI.
- Deviation handling, CAPAs and change controls.
- Method validations and equipment qualifications.
- Prepare and maintain specifications, SOPs and other GMP documentation.
- Internal/external audits and regulatory inspections.
- QP and QP delegate activities.
- QP release and batch confirmation.
Our expertise enables us to support you with QA, QC, and QP
We cooperate closely with our clients and across relevant departments to ensure that all quality related activities are carried out effectively and in compliance with cGMP. To this end, we can support you in the following areas:
- QA of manufacturing activities, batch release and QC documentation.
- Ensuring the batch has been manufactured and tested in accordance with accordance with GMP regulations, quality agreements and Marketing Authorizations.
- QA of Facility & Equipment.
- QA of Qualification & Validation activities (projects).
- QMS update and maintenance.
- Change control handling and quality documentation approval (SOPs, qualifications, validations, CAPA’s and deviations).
- Training: ensure that initial and ongoing training programs are developed, implemented and maintained, and that employees receive regular training.
- Internal/external audits and regulatory inspections.
- QC support within raw materials, water systems and production and packaging materials.
- Analytical test results review and approval.
- Release incoming materials and WFI.
- Deviation handling, CAPAs and change controls.
- Method validations and equipment qualifications.
- Prepare and maintain specifications, SOPs and other GMP documentation.
- Internal/external audits and regulatory inspections
- QP and QP delegate activities.
- QP release and batch confirmation.
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.
Are you interested in learning more about our Manufacturing Consulting services?
Pharma IT ensures your manufacturing processes reach and remain in compliance