Assay and Dissolution testing for Ciprofloxacin Tablets
[Assay and Dissolution testing for Ciprofloxacin Tablets]
EPTIS factsheet 834713 | Last revision 2021-03-09 | URL: https://www.eptis.bam.de/pts834713 https://www.eptis.bam.de/pts834713
| PT provider | ||||||||||||||||
| PT provider | Pharmaceutical Research and Development Lab, MUHAS Pharmaceutical Research and Development Lab, MUHAS | |||||||||||||||
| Based in | Tanzania | |||||||||||||||
| Language(s) | English | |||||||||||||||
| Remarks | Proficiency Testing Scheme for African Pharmaceutical Testing MUHAS Pharm R&D Lab is an ISO 17043:2010 accredited laboratory running proficiency testing scheme for pharmaceutical testing laboratories.The Lab also provides training, R&D and consultancy services in the pharmaceutical sector within Africa. It gained experiences on proficiency testing through participating in several rounds of proficiency testing (PT) schemes in the field including WHO External Quality Assurance testing schemes. Proficiency Testing is an interlaboratory comparison of samples against pre-established criteria. In an effort to build regional capacity for providing PT services in the pharmaceutical sector the EAC Secretariat in co‐ operation with PTB, the German Metrology Institute, started to support Pharma R&D laboratory, to become a regional PT provider for pharmaceutical testing laboratories. So far nine (9) regional Proficiency Tests (PTs) on solid dosage forms have been undertaken. The last PT was on Cotrimoxazole assay and dissolution. All the labs were promptly notified and requested to carry out root cause analysis of their results. There after the participated lab were invited for training as part of CAPA and sharing their experience with fellow colleagues in the field. We have a strong confidentiality policy, in a way that all labs are coded and their results are not shared to a third party. Why proficiency Working with US? Our PT schemes are uniquely provided as we have a well-established pharmaceutical technology laboratory in which pharmaceutical samples with desired different strength from that available on the market can be prepared in a way to mask product strength to the participating laboratories. Participants have flexibility to propose substance for the PT scheme based on the challenges they face in real daily practices. | |||||||||||||||
| Keywords | ||||||||||||||||
| Product groups |
Pharmaceutical products, drugs
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| Testing fields |
Analytical chemistry
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| Technical details | ||||||||||||||||
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| Aims of the PT scheme | ||||||||||||||||
| Target group of participants | African Pharmaceutical Testing Laboratories | |||||||||||||||
| Linked to specific legislation / standards | ISO 17o43 | |||||||||||||||
| Additional, subsidiary aims | Competence assessment | |||||||||||||||
| Number of participants | 100-200 | |||||||||||||||
| Accredited or otherwise reviewed by a 3rd party |
Accredited by KENAS on the basis of ISO 17043 YES |
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| Operation is commissioned / requested by | NO | |||||||||||||||
| Fees and frequency | ||||||||||||||||
| Participation fee | 160 | |||||||||||||||
| Regularly operated | Yes (ONCE A YEAR) | |||||||||||||||
| Year of first operation | 2013 | |||||||||||||||
| Contact details of the PT provider | ||||||||||||||||
| Provider | Contact person | |||||||||||||||
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Pharmaceutical Research and Development Lab, MUHAS
9-United Nation Road Dar Es Slaam Tanzania Phone: +255754453847 Fax: Web: http://pharmrd.muhas.ac.tz/ http://pharmrd.muhas.ac.tz/ |
Mr Raphael Shedafa
Phone: Fax: Email: raphael.shedafa@gmail.com raphael.shedafa@gmail.com |
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