The circulation of low-quality medicines is a major public health concern worldwide. This is especially a problem with antimicrobials, as they play a key role in the treatment of major infectious diseases such as malaria, tuberculosis, and HIV/AIDS. Poor-quality antimicrobials present a substantial barrier to providing proper clinical care, often leading to decreased treatment effectiveness, increased morbidity and even mortality, and the development of antimicrobial resistance (AMR). The key factor contributing to poor-quality medicines is weak pharmaceutical quality assurance (QA) systems. A good QA system has many interlinked components, which must be applied in concert to be effective. The major challenge for many resource-limited countries is prioritization—how best to allocate limited resources to accommodate the greatest needs in both technical (e.g., registration, laboratory testing, inspection, etc.) and managerial (e.g., laboratory management, documentation, training, etc.) areas of regulation.
The Pharmaceutical Quality Assurance activities, which started with Tanzania Food and Drugs Authority (TFDA), MSH/SEAM and MSH/RPM Plus in Tanzania, are being implemented in Zambia by a collaboration between the Pharmaceutical Regulatory Authority (PRA) of Zambia, RPM Plus, and TFDA. RPM Plus is working with in-country partners to put into place a standardized QA system which emphasizes quality system management, including Standard Operating Procedures (SOPs), documentation, and information/data reporting.
After an assessment of the regulatory capacity of PRA and a meeting with other in-country QA stakeholders, a plan was developed to build capacity of PRA and others partners for implementing an inspection network. The inspection scheme developed includes:
- Using Minilab at key ports of entry in Zambia
- Rigorous checking of registration status of products
- Checking for appropriate documents such as certificates of analysis, import licenses, and customs declarations
- Visual and physical inspection of consignment packaging and labeling
- Physical inspection of dosage form appearance
As a key initial step in the implementaion of this scheme, inspectors and a laboratory analyst from PRA, Churches Health Association of Zambia, and National Institute for Scientific and Industrial Research were trained in early 2007 with a focus on the above-mentioned areas of document verification, visual inspection, and Minilab testing. The training was based on an inspection training module developed collaboratively by PRA and RPM Plus.
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