The National Drug Quality Control Laboratory is one of the main pillars of the National Medicines and Food Administration, Ministry of Health, that plays a key role in ensuring the quality of medicines and medical devices. Founded in 1997, the NDQCL is mandated to conduct analytical tests for imported as well as locally manufactured pharmaceutical products for confirming compliance to standards of quality and to issue certificate of analysis. The laboratory is moving forward to achieve this mandate having four sections namely; Physicochemical, Microbiology, Quality Assurance, and sample management and storage.

However, the laboratory was not able on many occasions to test all parameters required by the monograph due to resource constraints, such as lack of critical analytical equipment, reference standards, chemicals and shortage of skilled human resource. So far, products of fixed dose combinations like anti-TB, anti-Malarial and ARVs are tested at external accredited laboratories where expenses are covered from Global Fund grant. The average cost per test sample is expensive (>1000 USD) which would be very difficult to manage upon grant termination.

The Ministry of Health envisioned to upgrade the laboratory to the accepted international standard and took initiative to address the priority gaps identified via the WHO benchmarking assessment team and USP-CePAT consultant in early 2017. Based on the recommendations given, budget was requested from the Global Fund grant for upgrading the laboratory to the expected competency level required by ISO/IEC 17025 and/or WHO prequalification. To date, the lab is fairly equipped with key analytical equipment and on-going efforts are made to secure additional budget for procuring the remaining critical instruments.

The assessment emphasized on the need of capacity building for staff members to familiarize with the contemporary techniques and procedures. Moreover, introduction of Quality Management System (QMS) was also stated as a priority task. Based on the recommendations, the laboratory was able to draft the required QMS documents (quality manual, safety manual, SOPs and forms). However, there still need expert for reviewing the draft QMS documents to meet the expected level of competency required by the international organizations.

In light of addressing the existing gaps, the NMFA/MoH is looking for hiring external QC expert who can stay 6-12 months to guide the accreditation process of the laboratory. Terms of reference (TOR) for the project is as follows.

Terms of reference (TOR)

Aim of the Contract

The aim of this contract is to hire an expert who can guide the accreditation process by institutionalizing the QMS capacity of the laboratory in line with the requirements of ISO/IEC 17025 standard and prepare for the application for accreditation.

Scope of Work:

The major components of the Technical Assistance are establishment of Quality Management System, conduct training to the technical staff on QMS and contemporary method of analysis, perform instrument calibration to some of the equipment found in the laboratory, assist the laboratory in establishing connection with other accredited regional laboratories, review the existing working documents of the laboratory.

Description of the Task:

The applicant/selected personnel will perform the following

Carry out a comprehensive assessment of the laboratory infra-structure and existing quality system arrangements with reference to compliance with ISO/IEC 17025 standard requirements,
Make recommendations and provide technical advice to fill in the identified gaps (non-conformities) and come out with road map for the accreditation scheme.
Review and finalize the existing draft QMS documents (quality manual, safety manual, SOPs and forms)
Capacity building for QC staff members to keep abreast with the contemporary method of analysis and instrument operation and troubleshooting
On-the-job training to familiarize staff members with the available analytical instruments
Train the technical personnel on the newly revised and developed working documents
Prepare equipment qualification plans
Perform equipment qualification by using the technical staff in the laboratory or by hiring a calibrating and qualifying firm
Identify and create attachment with accredited regional quality control laboratories
Guide accreditation process and apply to accreditation bodies
Provide an actionable recommendations and way forward for the laboratory

Deliverables:

The Consultant will be expected to produce the following deliverables

A detailed report on findings of the ISO 17025 documentation review and recommendations for addressing non-conformances found.
Work-plan for the development of outstanding documentation as required by ISO 17025 (as identified in the documentation audit)
Templates for the outstanding ISO 17025 documentation (SOPs, forms, work instructions, etc) as identified
Strategy for maintenance of quality system documentation
Periodic training for the laboratory staff in documentation system, instrument operation and qualification, and safety

Qualifications and experience of consultant:
Qualification and Skill:

A Post graduate degree in at least pharmaceutical analysis,
Qualification in Quality Assurance system
Excellent facilitation and interpersonal skill
Fluent in English

Professional experience

Should have a minimum of four (4) years’ experience as a quality manager in a drug quality control laboratory
Should be a trained lead auditor with a minimum of two years’ experience in auditing - ISO 17025 systems.
Should have knowledge and experience in documentation as required by ISO 17025
Should be trained in ISO9001 and ISO 17025
Should have knowledge and experience in compendia and contemporary method of analysis
Should have knowledge and experience with different laboratory equipment