Antecedentes
The Medicines Control Authority of Zimbabwe (MCAZ) was established through an act of parliament the Medicines and Allied Substances Control Act (MASCA) [Chapter 15:03]. It is the sole regulator of medicines, medical devices and allied substances in Zimbabwe. The Authority is mandated through this act to ensure that safe, effective and good quality medical products and allied substances are supplied onto the Zimbabwean market, through pre and post-market surveillance.
The MCAZ Microbiology laboratory is responsible for microbiological analysis of pharmaceutical preparations before and after they are distributed in the country. Currently, the laboratory performs three (3) test methods namely;
- Microbiological Assay of Antibiotics,
- Sterility Test (parenterals and ophthalmic preparations),
- Microbiological Examination of Non-Sterile Products.
In 2015, a World Health Organization (WHO) consultant performed an assessment, evaluation and review of the MCAZ Microbiology laboratory to check compliance of the management system and working standards against WHO Good Practices for Pharmaceutical Microbiology Laboratories. The WHO Consultant made a recommendation to the Medicines Control Authority of Zimbabwe (MCAZ) to renovate the Microbiology Laboratory in line with WHO Prequalification requirements. The Microbiology Laboratory was under remodelling for the past three (3) years and the project was funded by Global Fund and managed through the United Nations Development Programme (UNDP). The project was completed and handed over to MCAZ on the 5th of February 2021 after a WHO Technical Consultant conducted a virtual assessment of the remodelled laboratory against the WHO Prequalification requirements and found it to be structurally compliant.
The Medicines Control Authority of Zimbabwe intends to have the Microbiology Laboratory assessed for WHO prequalification in 2023. In preparation for the assessment, the Laboratory is currently developing and implementing a Quality Management System (QMS) in line with the requirements of the WHO Prequalification program. Although the laboratory has qualified personnel, they have limited experience in developing documentation for prequalification but would however want to ensure the success of this project. It is against this background that the laboratory is seeking technical assistance in developing QMS documentation that meets WHO requirements as well as guidance to establish a clear roadmap for WHO prequalification.
Deberes y responsabilidades
Objective of the assignment:
The objective of the consultancy is to assist the MCAZ Microbiology laboratory and Quality Unit in developing Quality Management System (QMS) documentation that meets WHO Prequalification requirements and a roadmap for WHO prequalification of the Microbiology Laboratory.
3.0 Scope of work
The assignment will involve a desk review of the current documentation and the identification of gaps in the laboratory documentation, practices and operations. The consultant will be required to assist the Laboratory to address and close the identified gaps. In performing these tasks, the consultant shall be guided by the following guidance documents amongst others:
- WHO Technical Report Series No. 961, 2011 Annex 6: WHO good manufacturing practices for sterile pharmaceutical products;
- WHO Technical Report Series No. 957, 2010 Annex 1: WHO good practices for pharmaceutical quality control laboratories;
- WHO Technical Report Series No. 961, 2011 Annex 2: WHO good practices for pharmaceutical microbiology laboratories.
- Any other relevant standards.
4.0 Duties and Responsibilities
The consultant shall;
4.1 Perform a desk review of the available QMS documentation for compliance to WHO prequalification and identify gaps. The gaps may include but not limited to; missing Standard Operating Procedures, forms, validation protocols, and inadequately written standard operating procedures.
4.2 Write a report on the identified gaps and present to MCAZ Top Management, highlighting critical areas and the identified gaps.
4.3 Assist personnel in the Microbiology Laboratory and Quality Unit to address the gaps by providing technical assistance in the development of missing documents and reviewing of QMS documents that do not meet WHO prequalification requirements.
4.4 Train MCAZ Microbiology and Quality Unit personnel on the implementation of the developed and reviewed QMS documentation.
4.5 Write a report on the level of compliance of the MCAZ Microbiology Laboratory upon completion of the tasks.
4.6 Liaise with the MCAZ Microbiology Laboratory Manager and Quality Manager throughout the duration of the consultancy to understand their needs.
5.0 Institutional Arrangement
The consultant will report to UNDP, MCAZ Microbiology Laboratory Manager and MCAZ Quality Manager.
6.0 Expected Outputs and Deliverables
Deliverables/Outputs | Estimated Duration to complete | Target Due Dates | Review and approvals required |
Document desk review on current QMS and Gap report | One calendar month
| February2023 | MCAZ Microbiology Laboratory Manager MCAZ Quality Manager UNDP |
Assisting and training MCAZ in addressing identified gaps. | One calendar month | March 2023 | MCAZ Microbiology Laboratory Manager MCAZ Quality Manager UNDP |
A report on the adequacy of the laboratory QMS to meet WHO Prequalification requirements | One calendar month | April 2023 | MCAZ Microbiology Laboratory Manager MCAZ Quality Manager UNDP |
7.0 Duration of Assignment, Duty Station and Expected Place of Travel
Contract duration: 3 months
The assignment will involve a site assessment of the facility to allow the consultant to familiarize with the new facility. The site assessment can be done physically or virtually depending on feasibility. Virtual meetings can also be conducted for any other engagements.
Competencias
8.1 Project and Resource Management: Ability to work independently, produce high-quality outputs.
8.2 Partnership building and teamwork: Provides constructive coaching, feedback and team building.
8.3 Communication:
8.3.1 Strong ability to write clearly adapting style and content to different audiences and speak clearly and convincingly.
8.3.2 Strong capacity to communicate clearly and timely when required.
8.3.3 Ability to produce high-quality practical advisory reports.
8.3.4 Ability to impart skills and information.
Habilidades y experiencia requeridas
9.1 Education
Advanced degree or equivalent in Microbiology, Biology, biomedical sciences, pharmaceutical sciences or related field.
- Experience
- At least 10 years’ experience in a WHO Prequalified Pharmaceutical Microbiology Laboratory.
- Good knowledge of SOP writing, QMS development and implementation for WHO PQ Laboratory requirements.
- Good knowledge of WHO norms and standards as well as prequalification for Microbiology Labs.
Language
Good command of English language
10.0 Evaluation criteria
Candidates will be evaluated using a combined scoring method with the qualifications and methodology weighted at 70% and the price offer weighted at 30%. Only candidates obtaining a minimum of 49% (out of 70%) points on the technical qualifications part will be considered for the Financial Evaluation.
10.1 Criteria for evaluation of qualifications and methodology (70 points maximum):
10.2 Criteria for financial evaluation (30 points)
10.3 Criteria for evaluation of qualifications and methodology (70 points maximum)
10.3.1 Relevance of education to the consultancy. (10 points).
10.3.2 Demonstrable experience in WHO Prequalified Pharmaceutical Microbiology Laboratory. (10 points)
10.3.3 Demonstrable experience in Auditing Microbiology Laboratory. (10 points)
10.3.4 Sound understanding of WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. (5 points)
10.3.5 Sound understanding WHO Good Practices for Pharmaceutical Quality Control Laboratories. (5 points)
10.3.6 Sound understanding WHO Good Practices for Pharmaceutical Microbiology Laboratories. (5 points)
10.3.7 Knowledge in ISO 17025. (5 points)
10.3.8 Knowledge in ISO 9001. (5 points)
10.3.9 Knowledge in WHO PQ requirements. (5 points)
10.3.10 Demonstrable experience and references in the assistance of Laboratories towards attainment of certifications. (10 points)