Malawi | Pharmacy and Medicines Regulatory Authority

Quality Control laboratory

The National Medicine Quality Control Laboratory is established under Section 79 of the PMRA Act. It aims at providing effective support to the Authority, making sure that analytical tests results obtained accurately describe the properties of the samples assessed, permitting correct conclusions to be drawn about each medicine and also serving as an adequate basis for any subsequent regulatory decision and legal action.
The Laboratory performs the following functions:

  1. Analysis of Finished Pharmaceutical Products (FPP’s) prior to Market Authorization by the PMRA
  2. Analysis of Medicines before distribution by the Central Medical Stores Trust (CMST)
  3. Assessment of medical devices before distribution
  4. Assessment of pharmaceutical products and medical devices as part of the Authority’s Post-Market Surveillance program
  5. Analysis of suspect ‘drugs of abuse’ for Law enforcement agencies
    The Laboratory is currently establishing a Quality Management System (QMS) according to ISO 17025: 2017 Standard. This QMS is established for purposes of gaining international recognition through accreditation. The NMQCL also participates in local and international inter-laboratory proficiency testing programs.