*MEDS Attains ISO 9001:2008 Certification* More....
MEDS QC Laboratory is WHO pre-qualified and is the:
i. First in Faith Based Drug Supply Organizations
ii. 4th in Sub-Saharan region
Without assurance that medicines are relevant to priority health needs and that they meet acceptable standards of quality, safety and efficacy, any health service is evidently compromised. - World Health Organization, 2007
Supply of good quality essential medicines is undoubtedly one of the pre-requisites for the delivery of health care. As a way to this realisation, MEDS put in place an elaborate and well documented quality assurance system that ensures the procurement and supply of safe, effective and good quality medicines and medical supplies. This is enhanced by a well equipped professionally run Quality Control Laboratory that started operations in 1997, necessitated mainly by two factors: 1) The liberalization of the Kenyan economy which opened the market to diverse sources of pharmaceuticals whose quality needed to be ascertained and 2) High costs and delays associated with sending samples to overseas laboratories.
WHO Pre-Qualification
MEDS Quality Control Laboratory was pre-qualified by World Heath Organisation (WHO) early 2009. This makes it the first Faith Based organisation globally and forth in Sub-Saharan Africa to attain this status.
WHO is a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health.
The WHO Pre-qualification Programme assesses whether quality control laboratories meet the recommended international norms and standards for the analysis of pharmaceutical products. This is aimed to ensure compliance with Good Practices for National Pharmaceutical Control Laboratories (GPCL) and relevant parts of WHO Good Manufacturing Practices (GMP).
MEDS Quality Control Laboratory was found to comply with standards recommended by WHO. This phenomenal achievement placed MEDS laboratory among a limited number of laboratories around the world that are pre-qualified by WHO. Further information can be found at WHO website: http://www.who.int/prequal/info_applicants/qclabs/prequal_quality_control_labs.htm.
What does this Pre-Qualification Mean?
MEDS Quality Control Laboratory is acceptable, in principle, for use by United Nations agencies, pharmaceutical manufacturers and other procurement organisations. The organizations in the region now have an easy access to a quality control laboratory for assessing quality of medicines. Building capacity for sustainable manufacturing and monitoring of quality of medicines in close co-operation with national regulatory agencies and other partner organizations goes a long way in ensuring that will go a long way in helping to uplift the quality of medicines within the country as well as the sub-Saharan region.
MEDS laboratory also participates in the WHO Proficiency Testing Scheme which enables it to compare its performance with other laboratories around the world. It has recorded good results in tests it participated within this scheme. Continued participation in this scheme in combination with other measures will ensure quality assurance of the laboratory.
Pre-Qualified Services
The laboratory is prequalified for physical and chemical analysis of finished products and active pharmaceutical ingredients.
Tests include assay, impurities and related substances by High Pressure Liquid Chromatograph (HPLC) Ultraviolet Visible (UV-VIS) detection; Gas Chromatograph (GC); UV-VIS spectro-photometry; volumetric titrations; and polarimetry.
Physical/chemical tests include pH; density; refractometry, viscosity, loss on drying; water content; disintegration; dissolution; uniformity of dosage units (mass, content); friability; tablet hardness; particulate matter test; specific optical rotation; heavy metals; sulphate ash; acid insoluble ash; acid value; iodine value; ester value, acetyl value; peroxide value; and saponification value.
Acknowledgements
MEDS appreciates support and encouragement received from WHO, Johnson and Johnson Group of Companies Donation Program (New Jersey, USA) and DIFAEM (German).
Quality Assurance