scholarly journals Optimization of Bayesian repetitive group sampling plan for quality determination in Pharmaceutical products and related materials

Author(s):  
Velappan Kaviyarasu ◽  
Palanisamy Sivakumar

Sampling plans are extensively used in pharmaceutical industries to test drugs or other related materials to ensure that they are safe and consistent. A sampling plan can help to determine the quality of products, to monitor the goodness of materials and to validate the yields whether it is free from defects or not. If the manufacturing process is precisely aligned, the occurrence of defects will be an unusual occasion and will result in an excess number of zeros (no defects) during the sampling inspection. The Zero Inflated Poisson (ZIP) distribution is studied for the given scenario, which helps the management to take a precise decision about the lot and it can certainly reduce the error rate than the regular Poisson model. The Bayesian methodology is a more appropriate statistical procedure for reaching a good decision if the previous knowledge is available concerning the production process. This article proposed a new design of the Bayesian Repetitive Group Sampling plan based on Zero Inflated Poisson distribution for the quality assurance in pharmaceutical products and related materials. This plan is studied through the Gamma-Zero Inflated Poisson (G-ZIP) model to safeguard both the producer and consumer by minimizing the Average Sample Number. Necessary tables and figures are constructed for the selection of optimal plan parameters and suitable illustrations are provided that are applicable for pharmaceutical industries.

2005 ◽  
Vol 34 (3) ◽  
pp. 799-809 ◽  
Author(s):  
S. Balamurali ◽  
Heekon Park ◽  
Chi-Hyuck Jun ◽  
Kwang-Jae Kim ◽  
Jaewook Lee

2016 ◽  
Vol 13 (10) ◽  
pp. 6568-6575
Author(s):  
Muhammad Aslam ◽  
Ali Hamed S Algarni ◽  
Ramsha Saeed

In this paper, sampling plan using exact and approximated approaches is presented when the quality of interest follows the exponential distribution. The designing both presented using the repetitive group sampling plan. The design parameters of the proposed sampling plans are determined through non-linear optimization. The efficiency of proposed sampling plans is compared with the existing sampling plans in terms of average sample number. The application of the proposed plans is discussed by industrial data.


2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Aijun Yan ◽  
Sanyang Liu

Acceptance sampling plans are useful tools to determine whether the submitted lots should be accepted or rejected. An efficient and economic sampling plan is very desirable for the high quality levels required by the production processes. The process capability indexCLis an important quality parameter to measure the product quality. Utilizing the relationship between theCLindex and the nonconforming rate, a repetitive group sampling (RGS) plan based onCLindex is developed in this paper when the quality characteristic follows the Weibull distribution. The optimal plan parameters of the proposed RGS plan are determined by satisfying the commonly used producer’s risk and consumer’s risk at the same time by minimizing the average sample number (ASN) and then tabulated for different combinations of acceptance quality level (AQL) and limiting quality level (LQL). The results show that the proposed plan has better performance than the single sampling plan in terms of ASN. Finally, the proposed RGS plan is illustrated with an industrial example.


2019 ◽  
Vol 9 (01) ◽  
pp. 27-33
Author(s):  
Naveen Kumar ◽  
Sonia Pahuja ◽  
Ranjit Sharma

Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release. Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed


Author(s):  
Vikas Rathee ◽  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
...  

: Regulatory is the heart of the Pharmaceutical Industries which acts as an interface between the industries and government authorities for the growth and development of pharmaceutical industry system of their respective country. In 2017, India was a pharmaceutical country valued at USD (United States Dollar) 13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of Chemicals and Fertilizers, the Department of Pharmaceutical Products said that the national pharmaceutical market's gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion. 19.14 billion US$ in 2019. The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20. The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article that top 10 pharmaceutical companies are doing business, their turnover in 2020 and challenge in today's era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.


2015 ◽  
Vol 38 (2) ◽  
pp. 413-429 ◽  
Author(s):  
Muhammad Aslam ◽  
Saminathan Balamurali ◽  
Chi-Hyuck Jun ◽  
Batool Hussain

In this paper, we present the designing of the skip-lot sampling plan including the re-inspection  called SkSP-R. The plan parameters of the proposed plan are determined through a  nonlinear optimization problem by minimizing the average sample number satisfying both the producer's risk and the consumer's risks. The proposed plan is shown to perform better than the existing sampling plans in terms of the average sample number. The application of the proposed plan is explained with the help of illustrative examples.


2021 ◽  
Vol 15 ◽  
Author(s):  
Eduardo Muniz Santana Bastos ◽  
Victor Diogenes Amaral da Silva ◽  
Silvia Lima Costa ◽  
Samira Abdallah Hanna

Background: Medicinal plants present activities against neurodegenerative diseases with potential for the pharmaceutical industries. Therefore, the objective of this study was to investigate the current panorama of patents and articles of Brazilian medicinal plants with pharmacological activities in the Central Nervous System (CNS), regarding such aspects as: the number of patents by countries, areas of knowledge and technological maturity. Method: We carry out a technological exploration on the Questel Orbit® platform with the descriptors: Agave sisalana P., Amburana cearenses A., Dimorphandra mollis B., Jatropha curcas L, Poincianella pyramidalis T. and Prosopis juliflora (Sw.) DC. with pharmacological activity, and a scientific exploration in PubMed and Science Direct associated with the CNS in the title, abstract and methodology. Results: A total of 642 patents were identified between the years 1999-2019. India, China and Brazil are highlighted, 6th place, out of a total of 48 countries. Of these, 30 patents were not in the National Institute of Industrial Property and 10% are Brazilian in biotechnology and pharmaceutical products. Eleven articles were used in PubMed and Science Direct with scientific domains (anticancer, neuroprotection and anti-inflammatory). The Federal University of Bahia is highlighted, showing Technology Readiness Levels (TRL4), basic skills of pre-clinical research. Conclusion: Brazilian public universities have a significant role in the scientific, technological and innovative development of therapeutic assets for CNS.


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