Director General explains the relevancy of testing Medical and Pharmaceutical products

Today 31st August 2017, Rwanda Standards Board (RSB) has welcomed and conducted Media visit to the new established Medical and Pharmaceutical Testing Laboratory.

The tour of the laboratory was led by the Mr. Raymond Murenzi the Director General of RSB accompanied by Mr. Antoine Mukunzi, the Manager and other staff in the National Quality Testing Laboratories Division. In his welcome remarks, Mr. Raymond Murenzi reminded that the core mission of Rwanda Standards Board (RSB) is to provide standards-based solutions for trade promotion, public safety and environmental protection, while Laboratory testing is one way of key services for trade facilitation. He added that Rwandan exports verification through Laboratory Testing ensures consumer safety, customer confidence in quality of the product tested, adds value to the product, enhances international market access for that particular commodity and eventually increases the national economy.


Journalists witness some tests

The incidence of counterfeiting pharmaceutical products and the proliferation of substandard quality medicines has been well identified internationally and constitutes a serious health hazard. It is primarily flourishing in developing countries where institutional capacity in regulation, inspection and law enforcement is weak and adequate funds for regular drug quality monitoring are missing. Counterfeiting of pharmaceutical products can take all kinds of forms, but the end result is, when administered to a patient that the consequences range from treatment failure, increased toxicity, and increased drug resistance, for example  with anti-malaria containing no active ingredient on market,  the trust of patients into health care and medicines is gradually fading away.

Given that background, Rwanda Standards Board, through support of the Ministry of Health, has established the Pharmaceutical Testing Laboratories with the mission to assist the Government of Rwanda to promote and protect public health by assuring the quality, efficacy, and safety of medicinal products and other health commodities.  The principal   function of the laboratory is to analyze medicines for public and private sector to ascertain the level of quality and efficacy of each medicine; imported or locally manufactured, analyze samples for registration and inspection purpose, carry out and organize proficiency testing with World Health Organization and other regional Quality Testing Bodies and provide data and advice on the quality of medicines to policy makers involved in medicines safety issues.
With the current scope below stated, the laboratory will continually be upgraded to ensure public safety requirements related to medical and pharmaceutical products testing are met, and it will further be accredited to ISO/IEC 17025 and World Health Organization (WHO) for international recognition in providing analytical services for pharmaceutical products of high standard.

Medical and pharmaceutical Testing laboratory currently has testing capabilities of the following parameters in anti Malaria, antiretroviral, anti TB and antibiotics:

• Assay on the active ingredients and Purity ( Chromatography, Titration, Limit Tests)
• Identity of product ( Spectroscopy, Chromatograph),
• Water content (loss on drying, Karl Fisher Titration),
• Appearance and friability
• Uniformity of  mass/dosage units
• Disintegration and dissolution studies
• Particle size analysis
• Acidity and alkalinity of solution

Laboratory analyst perform test  in the laboratory
Medical devices are also tested such as female condoms, male condoms and medical gloves. The laboratory is planning from financial year to start testing services of microbial limits tests, sterility testing, microbial contaminant identification, preservatives testing and microbial challenges, bacterial endotoxin and studies of extractable and leachable.


Condoms samples submitted for quality testing

Considering that RSB Medical and Pharmaceutical Testing Laboratory is located in a newly constructed, standalone, modern building with a variety of new and modern equipment for the testing of medicines, the ongoing EAC verification exercise for selecting potential laboratory that will host an EAC regional centre of excellence for provision of Chemical Reference Substances (CRS) for quality control of medicines has recommended the laboratory among potential laboratories to host the centre.