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.

Pharmacist Akoi Fahnbulleh currently serves as the Director of the Quality Control Laboratory at the Liberia Medicines and Health Products Regulatory Authority (LMHRA)

Pharm. Fahnbulleh has been in the employ of the Authority since 2010. Previously he served as Assistant Regulatory Officer/Senior Quality Control Laboratory Technician, Senior Regulatory Officer/Manager of the Department of Evaluation and Registration at the Authority.

He has represented the Authority and made presentations at several fora exemplifying the activities and achievements of the Regulatory Body.

He graduated from the University of Liberia with a Bachelor of Science Degree in Zoology and Bachelors of Pharmacy from the School of Pharmacy, University of Liberia. He went on to obtain certificates in the following areas: Clinical Trials, University of Ghana, Legon; Laboratory Preparation Towards ISO/IEC 17025:2005, USP/PQM/USAID/LMHRA; Pharmacology and Toxicology Internship, Raymond Poincare Hospital, Garches (France); Hands on HPLC, USP/USAID/LMHRA; Basic Tests and Sampling Procedure USP/USAID/LMHRA; Reproductive Health Commodity Supply and Data Management, UNFPA; Clinical Trials Training for Capacity building in Regional Centres of Regulatory Excellence (RCORE), Accra, Ghana; Mental Health, USAID/LCIP;  Diagnostics Research, ISGLOBAL, Barcelona Institute for Global Health (IGORCADIA Project); Dossier Evaluation Training, USP/PQM/USAID/LMHRA; Introductory Discussion to ICH/GCP, EDCTP/World Health Pharmaceutical Group/LMHRA; Internal Auditing, LMHRA; Teaching Methodology and Leadership Training, JRS/ MOE; Test Development and Administrative Procedures, WAEC.

Pharmacist Akoi Fahnbulleh is a candidate for M.Sc. in Public Health, Cuttington Graduate School and Professional Studies, Liberia. He is married with children.

Pharm Diana M. Jeator is serving currently as Deputy Director of the Quality Control Lab of the Authority. Prior to this position, she served as head of the Inspectorate and Post Marketing Surveillance Department. She also served as Pharmacy Technician at the Redemption Hospital.

She holds a Bachelor degree in Zoology and B.Pharm degree from the School of Pharmacy at the University of Liberia. She also holds certificates in GMP and Dossier evaluation.

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.
the Medical Devices Unit