Microbiological quality of pharmaceutical products in Bangladesh: current research perspective

Maintenance of Environmental Sustainability Through Microbiological Study of Pharmaceutical Solid Wastes

“…Indeed, in Bangladesh several research works have been conducted so far on the pharmaceutical products oriented diseases due to unhygienic management; however, such microbiological investigations on the pharmaceutical wastes, to our knowledge, have been carried out, for the first time in this country . As in case of many other developing countries, this is not unlikely that the pharmaceutical wastes might be disposed off directly into the environment by a major fraction of local industries; however, the potential environmental impacts are often less understood, and have only recently become a topic of research interest due to the rapid emergence of the MDR bacterial strains.…”

Study of the in vitro Anti-bacterial Susceptibility of the Commercially Available Antibiotics in Suspension or Solution Forms Collected within Dhaka Metropolis

“…As stated earlier, the current study was designed to deal with the anti-bacterial potential of the finished products which have already passed a range of quality control (QC) and quality assurance (QA) tests and assays from the corresponding manufacturers. Indeed the pharmaceutical companies are in practice to maintain the records of the quality control tests of the raw materials, the in-process checks (IPCs) during manufacturing, packaging and distribution within the market 3 . Interestingly some pharmaceutical companies especially the multi-national ones are well set with the compliance departments to deal with the market complaints regarding the loss of quality of any product(s).…”

“…During the industrial manufacturing of such antibiotics, the total quality management (TQM) starting from the raw materials ending up to the finished products strictly adhere to the good manufacturing practice (GMP) that is prescribed usually by the food and drug administration (FDA). The final microbiological quality of the finished products together with their antibacterial activities are of clinical significance as comprehensively outlined by the European Pharmacopoeia (EP), the British Pharmacopoeia (BP) and the United States Pharmacopoeia (USP) 3 . Indeed, the industrial manufacturing of the antibiotics principally based on the large scale production of microorganisms, which later convert the corresponding raw materials into the precise antibiotics by a process called fermentation which further undergoes the downstream processing for the recovery of antibiotics [3][4] .…”

“…Though antibiotics have long been used as the effectual chemotherapeutic agents for the mitigation of almost all diseases; however, the unfortunate incidence of drug-resistance has become a major health concern around the world [5][6][7] . A number of antibiotics are becoming lesseffective against a range of pathogenic bacteria which is alarming in course of mass public health since such a situation would lead to morbidity and mortality due to simple pathogenic infection onward 3,8 . Now a days the occurrence of the multi-drug resistant microorganisms as well as the prevalence of methicillin-resistant S. aureus (MRSA), vancomycin-resistant S. aureus (MRSA),vancomycin-resistant Enterococcus species, extended-spectrum ²-lactamase producing bacteria are not unlikely [9][10][11][12][13] .…”

Effectiveness of Antibiotics: Anti-Bacterial Activity or Microbial Drug Resistance?

“…While the liquid forms of antibiotics (i.e., the antibiotic solutions or suspensions) are usually suggested for the pediatric usage, the granular antibiotics are widely taken by the adults following the appropriate drug concentrations as well as the correct dose of administration to get rid of the microbial infection 2 . The industrial manufacturing of antibiotics is of significant importance in order to maintain the quality of the active ingredients of the antibiotics and additionally, it's really important to set the excipients at appropriate concentrations as per the recommendations and guidelines set by the British Pharmacopoeia (BP) or the European Pharmacopoeia (EP), or the United States Pharmacopoeia (USP) 3 . Moreover, as per the guidelines set by the Food and Drug Administration (FDA) as well as by the standard operating procedures (SOPs) set by the pharmaceutical manufacturing and packaging regulatory guidelines (usually guided both by the FDA and the Pharmacopoeia), the total quality management (TQM) is emphasized through the implementation of the good manufacturing practice (GMP) starting from the raw materials ending up to the finished products ready for distribution into the market for sales [3][4][5] .…”