Services
GMP Consultation
GMP Consultation
TAG-GMP assists and advises clients on compliance with cGMP according to the Local & international Authorities requirements. We have experience and success stories in this field in many countries in the middle east and Africa. We review general GMP compliance or focus on specific issues of concern and advice on potential solutions:
Establish Quality Management Systems
- TAG-GMP provides assistance and advice regarding the Establishment, implementation and maintenance of effective Quality Management System for GMP.
(It’s our pleasure if you contact us to know more about this valuable Service)
Preparations for new license
- TAG-GMP can provide the client with simulated inspection to prepare for regulatory inspections by local and international authorities, like EDA, SFDA, GCC, FDA, WHO, EMA, etc. and any other external audits.
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Validation & Qualification Studies
- Process validation.
- Cleaning validation
- DQ, IQ, OQ & PQ for the Utilities production machines.
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HVAC Technical Assessment
HVAC System is the muster power consumer in the building, also in the cleanroom facility, it is one of the main pillars which impact the performance of the cleanroom.
Our experts can provide Deep HVAC Technical Assessment for an existing facility to achieve various objectives like Energy Saving and compliance with cGMP. We have many experience and success stories in which we exceeded our client’s expectations. We have specialized process to enhance our successful and effective results and recommendations in order to give the support to our clients until achieving the optimum performance of the system:
- Current Situational Analysis.
- Documentation Revamping.
- Design Review & Qualification.
- Installation Qualification.
- Pre-Measurements.
- Gap Analysis Study.
- Design Modifications.
- Vendor Selection.
- Project Management for System Renovation.
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Training
TAG-GMP believes that our clients have the right to provides training to customer personnel in all areas of GMP. This training is delivered on-site in the form of a training course or is provided as part of the above services.
We have experiences and success stories of sharing knowledge and executing training courses with our clients in the following fields:
- HVAC Design fundamentals in Cleanroom.
- HVAC Testing Adjusting & Balancing.
- HVAC Qualification (DQ, IQ, OQ & PQ).
- Thermal Mapping and validation.
- BMS Validation.
- Medical Gases Qualification.
- Calibration.
And more…..
(It’s our pleasure if you contact us to know more about this valuable Service)