Tecnical department

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.

The Director of Audit, Mr. Sylvester Adams Kanneh, is a candidate for Master of Business Administration (MBA) in finance at the Cuttington University Graduate School and Professional Studies since 2018 and also holds a certificate of proficiency in internal audit from the Liberia Institute for Public Administration (LIPA). He holds a Bachelor’s Degree in Business Administration (BBA) from the University of Liberia.

He has had several years of experience, both in private and public sectors, including currently serving as Secretary General of the Montserrado Chapter of the ruling Congress for Democratic Change (CDC); as a petroleum retailer, he has served as secretary general of the Liberia Petroleum Products Retailer Union (LPPRU), a motivation he got from serving as accounts clerk with Petrol One, a petroleum distributor in Liberia.

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 the 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 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.