Assay and Disintegration Testing for Amoxicillin Capsules
[Assay and Disintegration Testing for Amoxicillin Capsules]
EPTIS factsheet 1075301 | Last revision 2023-09-04 | URL: https://www.eptis.bam.de/pts1075301 https://www.eptis.bam.de/pts1075301
| PT provider | ||||||||||||||||
| PT provider | Pharmaceutical Research and Development Lab, MUHAS Pharmaceutical Research and Development Lab, MUHAS | |||||||||||||||
| Based in | Tanzania | |||||||||||||||
| Language(s) | English | |||||||||||||||
| Remarks | 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 (10) regional Proficiency Tests (PTs) on solid dosage forms have been undertaken. The last PT was on Ciprofloxacin 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 | ||||||||||||||||
|
||||||||||||||||
| Aims of the PT scheme | ||||||||||||||||
| Target group of participants | African Pharmaceutical Testing Laboratories | |||||||||||||||
| Linked to specific legislation / standards | ISO 17043 | |||||||||||||||
| 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 | ISO 17043 | |||||||||||||||
| Fees and frequency | ||||||||||||||||
| Participation fee | USD 100 | |||||||||||||||
| Regularly operated | Yes (EACH 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 |
|||||||||||||||