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Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

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Published on: August 11, 2017

Quality analytics of Internet pharmaceuticals.

B Baert¹, B De Spiegeleer

¹Drug Quality and Registration (DruQuaR) Group, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium.

Analytical and Bioanalytical Chemistry

|June 29, 2010

Summary

Ensuring pharmaceutical product quality online is challenging due to counterfeit drugs. This review details quality attributes and analytical methods to control medicines traded via the internet.

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Area of Science:

Pharmaceutical Sciences
Analytical Chemistry
Regulatory Science

Background:

Online pharmaceutical trade presents significant challenges in legal compliance, distribution, information dissemination, and financial management.
A major concern is the prevalence of counterfeit and substandard drugs sold through illicit online platforms, demanding robust quality control measures.
Authorities face a difficult task in monitoring and ensuring the quality of pharmaceuticals available on the internet.

Purpose of the Study:

To provide a comprehensive overview of quality attributes for assessing finished pharmaceutical products traded online.
To review current analytical techniques employed for evaluating these quality attributes.
To address the challenges associated with ensuring drug quality in the context of internet pharmaceutical sales.

Main Methods:

Review of quality attributes including labeling, packaging, and physicochemical properties.
Analysis of methods for identification and assay of active pharmaceutical ingredients (APIs) and excipients.
Examination of impurity profiling, biopharmaceutical testing, and data interpretation strategies.

Main Results:

Identified key quality attributes essential for evaluating pharmaceuticals sold online.
Outlined various analytical techniques applicable to assessing drug quality.
Highlighted the complexities in ensuring product integrity and patient safety in e-pharmaceuticals.

Conclusions:

A thorough evaluation of multiple quality attributes is crucial for understanding the safety and efficacy of online pharmaceuticals.
Current analytical methodologies provide tools for quality assessment, but challenges remain in their consistent application and enforcement.
Effective strategies are needed to combat substandard and counterfeit medicines in the online pharmaceutical market.