GMP consultancy to support EDA

Contractual Arrangement : External consultant
Contract Duration (Years, Months, Days) : ‎60 working days
Job Posting : Sep ‎11, ‎2023, ‎2:58:‎21 AM
Closing Date : Sep ‎25, ‎2023, ‎4:59:‎00 PM
Primary Location : Egypt-Cairo
Organization : EM_EGY WHO Representative's Office, Egypt
Schedule : Part-time

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‎1. Purpose of consultancy
The main objective of this consultancy is to enhance the GMP inspection inside
the EDA to ensure the compliance of EDA regulatory inspection functions with
WHO standards as per the Global benchmarking tool requirements.
‎2. Background

As Egypt is one of the main producers of medical products including vaccines
in Eastern Mediterranean Region (EMR). WHO has been providing support to the
national regulatory authorities of Egypt since ‎1998, and more intensively
since ‎2006.

Egypt was assessed in ‎2010 and recognized by WHO as functional regulatory
authority for regulation of vaccines. The medical products regulatory system
in Egypt has been restructured in ‎2019 with the establishment of the Egyptian
Drug Authority (EDA).

In light of the Egypt vision ‎2030 and to enhance and develop the
pharmaceutical sector in Egypt, the creation of a robust national regulatory
authority as an autonomous entity has been a crucial pillar in the process and
in accordance with the Law (Law No. ‎151, ‎2019), the Egyptian Drug Authority is
the only entity in charge of drug control, registration, pharmacovigilance,
trade and supervision, it is also responsible for issuing operational licenses
to pharmaceutical industrial establishments.
The creation of EDA was aligned with recommendations provided by WHO during
the assessment of the regulatory system in Egypt and consequent follow ups and
discussions.
EDA is the sole regulatory body to oversee the quality, safety, and efficacy
of the medical products in Egypt.

EDA was benchmarked by WHO in March ‎2022. WHO announced that Egypt has reached
maturity level ‎3 for vaccines regulation (locally produced and imported).

Medicine regulatory system, on the other side, is being prepared for WHO
benchmarking.

Strengthening vaccine and medicine good manufacturing practices (GMP)
regulatory inspection (RI) function was identified as one of the areas for
further improvement during the last formal benchmarking of the vaccine
regulatory system as well as the self-benchmarking of medicine regulatory
system and accordingly an advanced GMP workshop has been held in Egypt for ‎30
inspectors from EDA in February ‎2023.

EDA's observed GMP audit has taken place by WHO team in July ‎2023 and many
areas of improvements have been recognized related to the preparation,
procedure, reporting of findings including the skills and competencies of the
inspectors during the GMP inspection.
‎3.* Work to be performed
Output ‎1 : Conduct situational analysis for the status of GMP
inspection in the National Regulatory Authority
* Deliverable ‎1.1: Conduct back up planning and several meetings with EDA responsible team for regulatory inspection.
* Deliverable ‎1.2: Desk review of all documents related to GMP inspection including legislations, regulations, guidelines, SOPs, and records.
* Deliverable ‎1.3: Conduct gap analysis and identify gaps and challenges to create a robust regulatory inspection system.
Output ‎2: Technically Support the revision of SOPs, guidelines
related to regulatory inspections along with all procedural documents related
to the same topic in EDA.
* Deliverable ‎2.1: Revise Draft SOPs/ guidelines/job descriptions and other GMP related documents in conjunction with EDA and verify the compliance of all drafted documents with WHO related guidelines.
* Deliverable ‎2.2: Provide technical advice after review and suggest modification in the final draft based on discussion and feedback from all stakeholders inside the EDA to seek their endorsement while engaging the Quality Department if needed.
Output3:* Provide technical support to the EDA in GMP audits in Egypt and
train inspectors on various GMP topics.
* Deliverable ‎3.1: Conduct coached GMP audits in ‎10 local producing companies in Egypt.
* Deliverable ‎3.2: Provide technical guidance to the inspectors in preparing for and conducting the GMP audit including CAPA implementation by the manufacturer.
* Deliverable ‎3.3: Train GMP inspectors from EDA on the following topics: classification of deficiencies, on how to write an inspection report, on the quality risk management, on the computerized system validation, on the inspection of QC/on the inspection of the HVAC/Data integrity/Sterile production/Investigational Skills/Evidence Based Inspection/communication and other GMP inspectors' competencies.
* Deliverable ‎3.4: Review, evaluate and provide guidance on the GMP inspection reports.

Output ‎4 Submit reports and final recommendations at the end of the
consultancy contract.
* Deliverable ‎4.1: Submit ‎2 progress reports during the period of the contract.
* Deliverable ‎4.2: Submit comprehensive assignment report including executive summary, findings, and comprehensive detailed recommendations.

‎4. Qualifications, experience, skills and languages

Educational Qualifications:
Minimum first university degree for lower end of range, an advanced university
degree for mid and high end of range, in a relevant field of pharmaceutical
sciences and/or pharmaceutical production and/or pharmaceutical quality.

Experience:
‎5 to ‎10 years of relevant work experience in GMP inspection and regulatory
systems related to different types of health technologies.

Skills/Technical skills and knowledge:
* Excellent skills in desk reviews, gap analysis, revising guidelines and SOPs and report writing skills
* Detailed understanding of FDA/ EMA/ WHO GMP guidelines.
* Experience in GMP regulatory inspections, GMP audit coaching
* Experience in developing training materials and conducting capacity building on GMP inspection

Languages and level required:
Fluent (Read - Write - Speak) English.
‎5. Location
The consultant will work in a hybrid format according to the needs of
national. The Consultant will work between the field/ WHO CO Egypt and the
desk review will be done through teleworking.

‎6. Planned timelines

(Part time consultancy total of ‎60 working days subject to confirmation)
Start Date: 1st of November ‎2023
End Date: 30th 0f April ‎2024

‎7. Medical clearance
The selected Consultant will be expected to provide a medical certificate of
fitness for work.

‎8. Travel
The Consultant is expected to travel.
Travel cost is excluded from this contract.

Additional Information
* This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
* Only candidates under serious consideration will be contacted.
* A written test may be used as a form of screening.
* If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
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