QUALITY CONTROL LABORATORY
The Quality Control Laboratory is the bedrock of the Liberia Medicines & Health Products Regulatory Authority (LMHRA), with the responsibility to conduct testing of all medicines and health products circulating the commerce of Liberia. Testing is intended to ensure that medicines and health products are safe, of good quality and efficacious for use by the general population of Liberia.
The major functions of the QC Lab are: 1. Laboratory management, 2. Pre and Post market analysis of pharmaceutical products regulated by the Authority as well as analysis of pharmaceutical products on request, 3. Issuance of certificates of analysis for all medicines and health products tested, 4. Development, review and validation of analytical methods and 5. Research into quality swing.
The testing activities at the QC Laboratory are performed via Quality Assurance and Quality Control. Quality Assurance (QA) is a set of activities for ensuring quality in the processes by which a product quality is assessed; while Quality Control (QC) is a set of activities for ensuring quality in medicines and health products.
The Quality Control Laboratory works in close collaboration with the other three technical departments to ensure that the mandate of the Authority is fully implemented.
STRUCTURE OF DEPARTMENT
The Quality Control Laboratory is headed by a Director, who is a registered Liberian pharmacist, assisted by a Deputy Director, who also is a registered Liberian Pharmacist; a Quality Control Manager for the Quality Control Section and a Quality Assurance Manager for the Quality Assurance Section, each with a deputy. Each Laboratory unit is headed by a Unit Supervisor, who supervises the Analysts/Technicians and Laboratory Assistants of that unit. The Control Laboratory also has a Research and Communication Officer for the Research and Communication Section, an IT and Secretarial Officers for the IT and secretarial sections, as well as a metrological officer.
The Laboratory comprises of four (4) Units: Physio-Chemical, Micro-Biology, Medical Devices and Cosmetics.
QUALITY CONTROL FUNCTIONS
Ensures that the management system is established, implemented and maintained in conformance with the requirements of ISO/IEC 17025:2017
Tests and verifies the product quality against the predefined standards.
Ensures that all measures are put in place to eliminate risk of non-conforming outcomes.
It ensures the safeguard of accuracy, reliability, and timeliness of lab results by ensuring early detection of results or measurement errors and the procedures to rectify them.
It makes sure that regularly quality control materials should be treated the same as the samples, from the beginning to the end of the run.
Laboratory quality control (QC) ensures that the lab processes and operations run efficiently and guarantees the production of accurate and reproducible results.
QUALITY ASSURANCE FUNCTIONS
Monitors technical functions;
Ensures compliance with the requirements of ISO/IEC 17025:2017;
Establishes an internal audit program and informs the Managing Director of audit outcomes
Ensures management system procedures, applicable standards, specifications and regulations are clearly followed;
Ensures that qualified, skilled and trained personnel and other resources are available;
Ensures that products and services satisfy customers requirements
Ensures that every step of the process of producing results-requesting, sampling, analysing and reporting- is monitored to ensure the correct tests are performed, that reliable results are produced.
FUNCTIONS OF THE PHYSIO-CHEMICAL UNIT
• Ensures quality controls for the approval of a drug identity, purity and content;
• Ensures that testing is carried out according to the manufacturer’s instructions submitted at registration.
FUNCTIONS OF THE MICRO-BIOLOGY UNIT
• Ensures routine tests for total counts and specified indicator microbial contaminants. For example, natural plant, animal and some mineral products for salmonella, oral liquids for E. Coli, topical for P. aeruginosa and S. Aureus, and articles intended for rectal, urethral, or vaginal administration for yeasts and molds.
FUNCTIONS OF THE MEDICAL DEVICES UNIT
• Tests to ensure product quality;
• Ensures that the device will reliably and safely perform in use;
• Validates device design. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing;
• Demonstrates dimensional checks and packaging verification;
• Ensures that varying degrees of biocompatibility testing is performed according to their classification taking into consideration the main source of guidance on the essential requirements for biological safety: ISO 10993- Biological evaluation of medical devices.
FUNCTIONS OF FUNCTIONS OF THE COSMETICS UNIT
• Ensures the efficacy and safety of products;
• Conducts tests for: Bacterial Aerobic Plate Counts;
• Fungal Aerobic Plate Counts;
• Preservative Challenge Testing;
• Stability and Shelf Life Testing;
• Non – Animal Safety/Toxicity Testing;
• Custom Testing etc.
Pharm. David Paye Namakpeh is a licensed Liberian Pharmacist currently serving as Director at
the Quality Control Laboratory (QCL) of the Liberia Medicines and Health Products Regulatory
Authority (LMHRA).
Pharm. Namakpeh graduated from the Diecke Refugee School in the Republic of Guinea in 1999
and later matriculate at the University of Liberia in 2004 and graduated in 2009 and 2015 with a
Bachelor of Science (BSc) degree in chemistry and a Bachelor of Pharmacy (BPharm) degree in
general Pharmacology respectively. Pharm. Namakpeh also holds master’s degree in public
Health (MPH) specifically in epidemiology from the Cuttington University located in Congo
Town. He is a candidate of Doctor of Pharmacy Degree at the school of University of Liberia.
Namakpeh has several certificates in clinical and regulatory related courses from China, USP-
Ghana, USP-Liberia PQM+, NAFDAC Nigeria among others.
Namakpeh has contributed to the work force of our beloved country Liberia in so many
capacities but limited to the following areas such as teaching in several high schools for 14 years,
Hospital Pharmacist at Curran Lutheran Hospital, Zorzor Lofa County, laboratory technician at
the Quality Laboratory of LMHRA, Quality Assurance Manager at LMHRA Quality Control
Laboratory and the list goes on.
In addition to his contributions to society and academic achievement, Pharm. Namakpeh has
participated in numerous international training and workshops.