scholarly journals METHOD DECISION FOR DETERMINING SPECIFIC MICROORGANISMS IN PHARMACEUTICAL PRODUCTS: AN OVERVIEW

Author(s):  
Gökhan CENGİZ ◽  
Evren ALGIN YAPAR

In the direction of microbiological quality control analysis in pharmaceutical products, determining the microbiological load of the product at the end-use stage is very important for human health. Quality control parameters in pharmaceutical products vary according to the structure of the type of product and administration route. In this context, according to the pharmacopoeias, parenteral products and eye drops are classified as sterile products and the other group of pharmaceuticals are classified as non-sterile products. However, non-sterile pharmaceuticals also must have a certain microbiological quality. For this reason, the pharmaceuticals should have a certain microbiological load and should not contain defined microorganisms specified to its type. Since the control of the microbiological quality of the products is important for safety, it should be determined by quality control analysis. In this study, standard methods used to detect specific microorganism in pharmaceutical products were compared. Application steps in standard methods and identification tests of specific microorganisms were examined. In addition, studies that are alternative to standard methods were evaluated. Peer Review History: Received: 5 September 2020; Revised: 20 October; Accepted: 28 October, Available online: 15 November 2020 UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file Average Peer review marks at initial stage: 6.0/10 Average Peer review marks at publication stage: 8.0/10 Reviewer(s) detail: Dr. Mujde Eryilmaz, Ankara University,Turkey, [email protected] Dr. Rawaa Souhil Al-Kayali, Aleppo University, Syria, [email protected]   Comments of reviewer(s): Similar Articles: CHEMICAL COMPOSITION AND ANTIMICROBIAL ACTIVITY OF THE ESSENTIAL OILS OF FOUR VARIETIES OF LIPPIA MULTIFLORA IN BENIN ANTIMICROBIAL ACTIVITIES FOR HADHRAMI HONEY ON GROWTH OF SOME PATHOGENIC BACTERIA

2021 ◽  
Vol 4 ◽  
pp. 1-6
Author(s):  
Krishna Gurung ◽  
Mamita Khaling Rai

Recently, the manufacturers of pharmaceuticals have improved the quality of non-sterile pharmaceuticals in such a way that such products contain only minimal bioburden. However, the production of sub-standard cough syrups and multivitamin syrups may cause non-therapeutic effect in patients, particularly in children. For this reason, this study was conducted to evaluate the microbiological quality of cough syrup and multivitamin syrups marketed in Pokhara, Nepal. Different brands of 15 cough syrups and 15 multivitamin syrups were collected from different vendors of Pokhara and the spread plate technique was performed to enumerate the microbial contaminant from the collected samples. Among 15 cough syrups, 12 samples were found to be contaminated with bacteria and nine samples were found to be contaminated with fungi. Similarly, among 15 multivitamin syrups, 10 were found to be contaminated with bacteria whereas 12 were found to be contaminated with fungi. Escherichia coli was not isolated in any samples. Overall, 14(93.33%) of cough syrup and 13(86.67%) of multivitamin syrups were found to be contaminated by either bacteria, fungi, or by both which exceeded the acceptance limit of International Pharmacopeia. The prevalence of these microorganisms in pharmaceutical products such as syrups samples may indicate the unhygienic condition, defect in production, poor adoption of Good Manufacturing Practice, ineffective preservatives and inadequate quality control. Though these products fall under non-sterile pharmaceutical products, so they need not require sterility but these drugs must conform to the microbiological purity criteria set in the appropriate pharmacopeial standard. These contaminated syrups explain the poor treatment and complicacy of the uncompromised people and the sick children.


2018 ◽  
Vol 8 (2) ◽  
Author(s):  
Ida Ayu Nuh Kartini ◽  
Dwi Jayanthi Syarief

Companies need to maintain and improve the quality of products derived by applying a good quality control, because quality is an important factor in improving satisfaction and loyalityas consumers, as well as PT. PG .Gorontalo ; Six Sigma methods that have high discipline can help develop and deliver near-perfect products. The purpose of this study was to determine how the value of sigma PT .PG . Gorontalo and what factors of product defects. In this analyzis , researchers took 3 months of data production and analyze the Six Sigma DMAIC method. Researchers examined / analyzed using a questionnaire and the report of production to help get the material of analyzis. From this research , it has been showed that the presence of defects of products in the production process of PT. PG. Gorontalo at 5.664, 72 DPMO. It is also known that the cause is the human factor , machines, methods, materials, and environment. Based on these results , we can conclude that the value of sigma PT. PG. Gorontalo is located at 4 to 4.5 sigma, the factor most dominant cause of disability is due to lack of proper vacuum pressure


Planta Medica ◽  
2011 ◽  
Vol 77 (05) ◽  
Author(s):  
W Ahmad ◽  
MS Khan ◽  
SMA Zaidi ◽  
SS Jameel ◽  
S Ahmad

1995 ◽  
Vol 31 (5-6) ◽  
pp. 75-79 ◽  
Author(s):  
M. Würzer ◽  
A. Wiedenmann ◽  
K. Botzenhart

In Germany the application of procedures such as flocculation and filtration in the preparation of drinking water results in the annual production of an estimated 500,000 t of sediments and sludges. Some of these residues have a potential for being reused, for example in agriculture, forestry, brickworks or waste water treatment. To assess the microbiological quality of residues from waterworks methods for the detection of enterobacteria, Escherichia coli, Salmonella, Pseudomonas aeruginosa, Legionella, poliovirus, Ascaris suis eggs and Cryptosporidium have been evaluated regarding their detection limits and were applied to various residues from German waterworks. Results show that sediments and sludges may contain pathogenic bacteria, viruses and protista. When residues from waterworks are intended to be reused in agriculture or forestry the microbiological quality should therefore be considered.


PLoS ONE ◽  
2015 ◽  
Vol 10 (10) ◽  
pp. e0139868 ◽  
Author(s):  
Mohan A. V. S. K. Katta ◽  
Aamir W. Khan ◽  
Dadakhalandar Doddamani ◽  
Mahendar Thudi ◽  
Rajeev K. Varshney

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