BACKGROUND

WHO has been providing technical assistance to support the Medicines Quality Control Laboratory (MQCL) in Papua New Guinea. With technical partners, work has been made to establish and progressively operationalize the MQCL for it to perform analysis of essential medicines samples. This capacity is aimed at effectively supporting product registration, licensing, and post-marketing surveillance at the Pharmaceutical Services Standards Branch of the National Department of Health (NDOH).

Since its official inauguration in 2017, the MQCL has worked to support the NDOH in monitoring the quality of essential health products in the country. By end of 2020, the following are some of the key accomplishments and milestones of the laboratory:  (1) training of quality control analysts and conduct of competency assessment and mapping of key personnel; (2) establishment of a Laboratory Quality Management System (QMS) based on WHO and ISO standards; (3) development of Operating Procedures, Quality Manual and a Post-Marketing Surveillance Framework; (4) conduct of medicines quality survey in 9 provinces and investigative testing of samples, including antimalaria, anti-TB, and other essential products; and, (5) development of a 5-year national laboratory strategic plan, (proposed) pricing structure and forecasting tools.

With the ongoing revision of the Medicines and Cosmetic Act of 1999 which recognizes the need for institutionalization of the WHO-recommended regulatory functions, including quality control and testing and post market surveillance (PMS), MQCL will play a more significant role in the country’s regulatory system. Achieving WHO pre-qualification for the MQCL also remains critical to the country’s ability to have a fully functioning regulatory authority with a national quality control laboratory able to support key regulatory functions.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

This work aims to provide technical assistance to Papua New Guinea in contributing to establishing a functioning medicines regulatory system that ensures the quality, efficacy, and safety of medical products. Specifically, this technical support aims to strengthen the capacity of the Medicines Quality Control Laboratory (MQCL) towards WHO prequalification through the following strategic outcomes: (1) established and well-functioning Quality Management System for quality assurance of testing activities; (2) improved technical capacity to perform compliance and investigative testing; and, (3) completion of key technical processes, procedures, and documentation towards WHO Prequalification.

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

The supplier, in coordination with NDOH and WHO Papua New Guinea and close collaboration with key partners and stakeholders, will undertake a programme of work according to the strategic activities identified below.

Activity 1: Establish a well-functioning Quality Management System to provide quality assurance to testing activities

Activity 2: Improve technical capacity of the Medicines Quality Control Laboratory to perform compliance and investigative testing

Activity 3: Complete key technical processes, procedures, and documentation necessary towards WHO Prequalification of the Medicines Quality Control Laboratory

METHODS TO CARRY OUT THE ACTIVITY

Activity 1: Establish a well-functioning Quality Management System to provide quality assurance to testing activities

• • Complete a technical skills competency evaluation of select staff on their application of validated testing methods, usage of software, and preparation of the required chemicals, reagents, and standard solutions
• • Implement a laboratory training plan and conduct QMS training for MQCL which will include, but not limited to, the following: uncertainty of measurement; good documentation practice; laboratory risk management; WHO assessor training; corrective actions and risk planning; internal auditing; data integrity; development of laboratory validation masterplan, including computer system validation; reagent management and handling; management review
• • Provide technical assistance for proficiency tests, interlaboratory tests, and mock audit
• • Strengthen capacity on laboratory equipment maintenance and calibration to build self-reliance and sustainability of the laboratory’s instrument maintenance program
• • Provide technical assistance on laboratory management through theoretical lectures and hands-on training on topics such as, but not limited to, among other management topics, principles of leadership, effective budgeting, strategic planning, sustainability planning, process design, and performance evaluation and development

Activity 2: Improve technical capacity of the Medicines Quality Control Laboratory to perform compliance and investigative testing

• • Conduct technical review of laboratory data to create and implement a process for review and approval of test results before release
• • Conduct trainings on compliance and investigative testing, including the following topics: validation and verification, analyses of impurities and testing techniques (Fourier transform infrared spectroscopy, Karl Fischer, high-performance liquid chromatography, advanced dissolution)
• • Support implementation of guidelines for post market surveillance towards its institutionalization as a key regulatory function within the NDOH PSSB
• • Support MQCL in planning for the second national medicines quality survey
• • Conduct progress reviews and supervisory visits to review the progress of implementation and engage stakeholders
• • Support dissemination of data from the First National Medicines Quality Survey and release of publication that outlines PNG’s pharmaceutical landscape and proposed framework for improving the quality of priority essential medicines in the country

Activity 3: Complete key technical processes, procedures, and documentation necessary towards WHO Prequalification of the Medicines Quality Control Laboratory

• • Develop and submit Laboratory Information File to trigger the WHO PQ process
• • Support MQCL in WHO collaborative assessment, planning a visit, and assessment visit
• • Support MQCL to respond to WHO findings and corrective actions
• • Support MQCL to help address potential issues that surface during this post-accreditation

QUALIFICATIONS & EXPERIENCE

EDUCATION

• • Essential: Expertise in pharmaceutical sciences, analytical chemistry, quality assurance/control of pharmaceuticals and instrumentation
• • Desirable: Expertise in pharmaceutical regulatory systems and public health

EXPERIENCE

• • Essential: Minimum of 15 years of experience in developing quality standards for medicines, workforce development in medicines quality assurance and supporting laboratories for accreditation/prequalification; work experience in Papua New Guinea in the area of medicines quality assurance and pharmaceutical regulatory systems
• • Desirable: Experience working with other WHO/UN offices and international organizations

TECHNICAL SKILLS & KNOWLEDGE

• • Essential: Pharmaceutical sciences, analytical chemistry, quality assurance/control, instrumentation, quality management systems, laboratory information systems, quality management systems, and laboratory systems assessment and accreditation 
• • Desirable: Health systems strengthening and public health

LANGUAGES

• • Fluency in English (reading, writing, and speaking).

COMPETENCIES

• • Communicating in a credible and effective way
• • Producing results
• • Moving forward in a changing environment
• • Fostering integration and teamwork
• • Knowing and managing yourself

APPLICATIONS

Qualified and interested specialists should submit the following documents to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 1 June 2021

• • Curriculum Vitae (for individual contractors) or Company Profile (for institutional applications)
• • Expression of Interest (cover letter). The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed fee and timeline.
• • Technical and financial proposals

Please use Tender Notice No. 128974 as subject to all submission. Only successful candidates will be contacted.