Table 4 Screening Technologies – Ideal Qualities
Region | Ideal Qualities |
|---|---|
Africa | Nigeria |
STs should be: â–ª battery powered â–ª easy to use â–ª fast â–ª portable â–ª provide high sensitivity and specificity results â–ª quantitative â–ª reliable â–ª run microbiological and impurity profiling tests | |
Zimbabwe | |
STs should be: â–ª accessible â–ª centralized and automatic data back-up â–ª easy to calibrate â–ª easy to use â–ª employ non-destructive sampling â–ª able to follow U.S., British, or International Pharmacopeia test methods â–ª inexpensive â–ª offer local access to technical support â–ª provide instant reporting â–ª quick setup time | |
Americas | Argentina |
STs should: â–ª determine levels of impurities â–ª employ non-destructive sampling â–ª perform instant microbiological counts | |
Mexico | |
STs should be: â–ª compact â–ª cost-effective â–ª easily interpretable results â–ª easy to calibrate â–ª easy to use â–ª employ non-destructive sampling â–ª equipped with a camera and/or barcode reader â–ª have the capacity to test all products without having to develop a labor-intensive spectral library â–ª inexpensive â–ª portable â–ª provide high sensitivity and specificity results â–ª capable of rapid analysis â–ª generating results comparable to standard compendial analyses (i.e., limits of detection, quantification) with the ability to extract the data | |
United States of America | |
Surveillance and screening technologies should be: â–ª able to analyze both product and packaging â–ª easy to maintain â–ª easy to use â–ª capable of big data analysis and linkage â–ª inexpensive â–ª rugged | |
Eastern Mediterranean | Egypt |
STs should be capable of: â–ª providing qualitative results of active pharmaceutical ingredients prior to production â–ª testing most excipients | |
Jordan | |
STs should: ▪ provide accurate results ▪ have the capacity to check the quality of finished products ▪ be handheld ▪ have a touchscreen ▪ include an extensive and validated spectral library ▪ include in-country customer service ▪ be inexpensive ▪ have long battery life ▪ provide quantitative results ▪ support all pharmaceutical products (i.e., not just one manufacturer’s products) | |
Southeast Asia | India |
Mobile vans should include: â–ª ability to conduct rapid on-the-spot analysis of medicines â–ª disintegration tests â–ª high sensitivity and specificity technologies â–ª high performance liquid chromatography â–ª staffing by an analyst, inspector, and a laboratory assistant | |
Western Pacific | Philippines |
STs should: â–ª provide accurate results â–ª include customer service â–ª provide data that are transferable to computers without requiring other systems/software â–ª be easy to maintain â–ª provide faster quality control testing of raw materials and finished product throughout its shelf life â–ª be inexpensive â–ª be reasonable in size and weight â–ª provide results comparable to those of benchtop instruments â–ª be sensitive â–ª be specific â–ª be user-friendly | |
China | |
STs should: â–ª include barcodes â–ª be compact (i.e., suitcase size) â–ª be easy to maintain â–ª follow U.S. Pharmacopeia monograph specifications â–ª be handheld â–ª include in-country customer service â–ª be inexpensive â–ª have long life span â–ª provide rapid screening results â–ª be robust â–ª use less organic solvents |