Medicines quality control testing evaluates the product’s parameters of potency, dose uniformity, specificity, efficacy, stability, identity and purity. The MQCSD employs chemical/physiochemistry methods of analysis from simple physico-chemical tests to more complex and frequently used techniques such as Spectrophotometry (UV/VIS, Infra-red) and High-Pressure Liquid Chromatography (HPLC). The Department confirms that a medicine is compliant with its stated label claim using internationally recognized monographs and standards such as the British Pharmacopoeia (BP) and United States Pharmacopeia (USP), which specify the required tests and acceptable limits for individual medicine formulations. Manufacturer’s test methods and reference standards may be employed when the product makes no stated claim to either standard.
The World Health Organization and Pan American Health Organization identify market surveillance and control as essential regulatory functions of national medicines regulatory authorities to ensure the good quality of medicines placed and available on the market to consumers and health professionals. A market surveillance programme is a key activity for monitoring medicines quality along the supply chain and is supported by the vital component of laboratory testing. It is recommended to prioritize testing using a risk-based approach for best use of resources (human, financial, technical) especially for small island states such as the Caribbean countries because it is not possible to test every medicine or product and there are many points along the supply chain to monitor. The MQCSD has implemented a risk-based post market surveillance (PMS) programme for assessment of the quality of selected medicines since 2018 with support from the Pan-American Health Organization.
1. Proactively conduct surveys of priority medicines selected using risk-based criteria, across CARPHA Member States, to evaluate their compliance to standards of quality, safety and efficacy.
2. Detect possible market penetration of substandard/ falsified, or unregistered products as applicable within a country.
3. Develop/strengthen capacity in countries (national regulatory authorities, procurement bodies and national medicines quality control laboratories) for sampling and quality testing of medicines on the market
All CARPHA Member States are eligible to participate. The activities of the programme include:
Identification and communication of selected
Sampling of medicines by national medicines regulatory authorities/procurement bodies
Submission of samples to the MQCSD with appropriate documentation
Testing of samples by the MCQSD
Communication of results in Certificates of Analysis to submitting CARPHA Member State and reporting of programme activities to CARPHA Member States
MQCSD has developed a Post-Marketing Surveillance Guide for Small Island Developing States to:
To assist national medicines regulatory authorities/ procurement bodies of CARPHA Member States in the conduct or improvement of their national post market surveillance activities.
To describe the risk-based criteria and procedures for the MQCSD’s PMS programme.
This Guide serves as a tool that may be used by national medicines regulatory authorities and procurement bodies. It is supplemented by training workshops and updated according to new approaches to strengthen medicines regulatory systems
Why is Post Market Surveillance and Monitoring of Medicines Critical?
Good quality, safe, and effective medicines are key for strong health systems, regulation and good public health.
Substandard and falsified medicines may harm patients and cause disease treatment failure, lowering confidence in medicines and health systems
Other factors may impact quality and/or safety of medicines while on market e.g. storage, environment conditions, transportation
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