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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
Testing fields Analytical chemistry
Technical details
Test item Tested property Testing method
Tablets ready for analysis Assay International method/according to laboratory selection
-
Dissolution International method/according to laboratory selection
-
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

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
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
If you find any mistakes please contact the responsible EPTIS coordinator in Tanzania, Mr Donald Masuku. Mr Donald Masuku.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.21