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| Reference: | 3366 |
| Country: | Democratic People's Republic of Korea |
| Multiple country event: | No |
| Region: | SEARO |
| City: | Pyongyang |
| Start date: | 28 July 2011 |
| End date: | 10 October 2011 |
| Estimated duration: | three weeks |
| Status: | Completed - Complété |
| | (The mission has taken place) |
|
| Title: | Strengthening of the National Drug Quality Control Laboratory |
| Type: | Mission |
| Terms of Reference: | The consultant will conduct an exhaustive assessment of the National Quality Control Laboratory and shall be guided by the following key areas of focus;
a) Assess the existing laboratory for international standards compliance (management system, organization, document control, equipments, qualifications, validation, personnel and operational procedures);
b) Conduct a GAP analysis showing the detailed corrective and preventive actions needed to comply with the international standards;
c) Provide support to define technical specification for necessary and basic equipments and supplies that could be procured within the limit of budget assigned for the QC lab (note the budget is limited);
d) Develop guidelines for sampling and handling of samples at the laboratory;
e) Establish a system to monitor quality control of TB and ant-malarial medicines within the country;
f) Conduct training needs analysis for the DQCL staff covering the technical and managerial aspects.
As a second level of technical support:
• Assess the compliance of the lab infrastructure, equipment, organizational setup, and operational procedures against WHO Guidelines prequalification requirement.
• Determine the scope of tests and procedures that can be applicable and within WHO Guidelines prequalification requirement.
• Prepare a GAP analysis report and presentation showing the detailed corrective and preventive actions needed to comply with WHO Guidelines prequalification requirement.
• Prepare action plan for completing analytical instruments qualifications, which must be performed according to WHO Guidelines prequalification requirement.
• Guide the development of the "Quality Manuals" needed to attain the ISO/IEC 17025:2005 accreditation including the technical procedures, work instructions, and relevant forms and templates.
• Produce an action plan for obtaining WHO Guidelines prequalification requirement. |
| Training Opportunity: | No |
| Website: | |
| Purpose 1: | Other |
| Purpose 2: | Laboratory strengthening |
| Purpose 3: | |
| Other purpose: | QC strengthening |
|
| Entered by: | WHO/SEARO |
| Partner 1: | |
| Partner 2: | |
| Partner 3: | |
| Contact name: | Muzafarova, Ms Nigorsulton |
| Contact email: | muzafarovan@searo.who.int |
| Other agencies: | |
|
| Funding needs: | No |
| Funding source: | Other, specify / Autres, spécifiez |
| Other funding source: | UNICEF, GFATM R 9 grant |
| Available funding: | $ 0 |
| Funding gap: | $ 0 |
| Global Fund reference: | |
|
| Comments: | Required as soon as possible. Interested consultants are required to send us their CV ASAP.
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There are no experts (roster) associated with this event. There are no experts (non-roster) associated with this event.
Date Created: 11 April 2011
Entered By: SEARO
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