Emphasizing the Importance of Assuring Product Quality

Raymond R. Tjandrawinata, Director of Business Development and Scientific Affairs, Dexa Medica

In early 2023, the World Health Organization (WHO) reported that over 300 child deaths in 2022 were related to tainted drugs in The Gambia, Indonesia, and Uzbekistan. The cough syrups available without a prescription had ethylene glycol (EG) and diethylene glycol (DEG) contamination. Even in modest doses, they can be lethal and induce severe renal damage. The majority of the kids weren't older than five. Given the comparable prior instances, the industry should have had enough time to make the required adjustments to prevent this.

Cough syrup tainted with diethylene glycol claimed the lives of over a hundred Americans in 1937, the majority of them being youngsters. DEG poisonings have also been documented in recent history in China, Argentina, Bangladesh, Nigeria, Haiti, Panama, India, and, most recently, the Gambia and Indonesia.

Diverse factors can introduce diethylene glycol into the supply chain, including incorrect product labeling, human error, and deliberate adulteration by suppliers or manufacturers to increase sales. By examining the components, the manufacturer can efficiently determine the presence of diethylene glycol and other risks. For some products sold in the US, this kind of testing is mandated by law. The resources and standards for quality assurance are similar in a few low- and middle-income nations.

According to the WHO, there have been additional deaths in a similar manner in Haiti in 1995 and Panama in 2006. As a result, in a 2009 revised monograph, the United States Pharmacopoeia (USP) adopted a Gas Chromatography (GC) method that can separate and quantify ethylene glycol and diethylene glycol in glycerin.

Pharmaceutical suppliers and manufacturers should also supply safe, high-quality pharmaceuticals. The intricate nature of the pharmaceutical supply chain calls for a heightened focus on regulatory oversight of robust quality controls for raw material testing. Companies should have had enough time to modify to avoid these situations. Closing the quality gaps in pharmaceutical ingredients would enable improved patient safety and prevent tragedies like the recent deaths of children in The Gambia and Indonesia.

The following is something that pharmaceutical manufacturers need to be aware of: buy only pharmaceutical-grade excipients from reputable and certified vendors.

1. Perform thorough testing when supplies are received before producing final goods.

2. Ensure the quality of the product, for example, by providing certifications of analyses based on relevant test findings.

3. Maintain correct, comprehensive, and appropriate records of all material purchases, testing, manufacturing, and distribution to enable traceability if an occurrence requires inquiry.

Pharmaceutical quality assurance aims to reduce costs by upholding quality and adhering to pertinent norms and standards

In this instance of contaminated cough syrups, the concern concerns an excipient in the product, not the active pharmaceutical ingredient (API). Therefore, all components used in the pharmaceutical manufacturing process, not just the API, must be assessed and tested to full monograph specifications. More than limited testing may be required to detect harmful impurities that present a risk.

Before any ingredients, excipients, or active components are utilized in the manufacturing process, the site management must always ensure that they have been evaluated and proven appropriate and safe.

The pharmaceutical sector frequently needs to pay more attention to the duties of the quality control unit, even with sophisticated control systems in place. A common cause of this is a misinterpretation of the function and boundaries of the quality unit, wherein specific actions may depart from anticipated standards.

Organizations can define their quality requirements and set appropriate specifications and measures for their quality assurance, which can be carried out internally or by an outside party. Quality assurance procedures in the pharmaceutical sector must guarantee that quality standards are fulfilled from the product's conception to its post-purchase maintenance.

Pharmaceutical quality assurance includes several vital tasks. It entails the transfer of technology, which entails outlining the value chain's activities, going over the work phases, creating tests and procedures, offering instruction, and setting rules. A comprehensive record of quality measures is ensured by the supervision of record transmission and archiving, made possible by documentation. Programs for quality management are designed to maintain standards and investigate inconsistencies. Sampling acquired goods, approving production procedures, assessing supplier deliveries, carrying out inspections, putting controls in place, and maintaining test equipment are all part of ensuring product quality. Enforcing plans and confirming resource planning requires validation. Together, these roles seek to uphold strict quality requirements that guarantee the dependability and security of pharmaceutical products.

To sum up, quality assurance is critical in guaranteeing product safety and meeting customer requests throughout a product's life cycle. The pharmaceutical business regularly assesses client requirements and highly values quality assurance. Adopting strategies that facilitate this process without placing an undue financial burden on the company is crucial. Pharmaceutical quality assurance aims to reduce costs by upholding quality and adhering to pertinent norms and standards. Businesses can maintain high standards of quality and provide goods that satisfy the demands and expectations of their clients by adhering to these principles. If these guidelines were followed, numerous nations could have been able to prevent needless infant deaths brought on by subpar QA performance.