scholarly journals Managing automation developrent in harmony with the rest of an international company—a QC laboratory manager's perspective

1998 ◽  
Vol 20 (3) ◽  
pp. 91-94
Author(s):  
Paul Newton
Keyword(s):  
Pharmaceutical Products ◽  
Test Methods ◽  
Single Site ◽  
Collaborative Management ◽  
Laboratory Automation ◽  
International Harmonization ◽  
A Company

Significant opportunities and challenges are presented when transitioning from managing laboratory automation development of pharmaceutical products at a single site to collaborative management with multiple domestic and international sites. Prior to integrating Glaxo and Burroughs Wellcome about two years ago, each company had expertise in laboratory automation, but neither had a strategy for consistent business-justified laboratory automation. The approach for international harmonization of automation development of pharmaceutical test methods that the integrated company has adopted is presented. Some items to consider before undertaking a company-wide automation development harmonization programme are offered for consideration. Experiences encountered and future planned benefits are discussed.

scholarly journals Laboratory automation impact on antimicrobial resistance

2019 ◽  
Vol 40 (2) ◽  
pp. 66
Author(s):  
Patrick R Murray
Keyword(s):  
Fundamental Problem ◽  
Test Methods ◽  
Rapid Diagnosis ◽  
Laboratory Automation ◽  
Test Results ◽  
Clinical Value ◽  
Bacterial Cultures ◽  
Identification Of Bacteria ◽  
Diagnostic Microbiology ◽  
Traditional Approaches

Antibiotic resistance in common bacterial pathogens, such as Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae, has significantly limited the therapeutic options available for management of infectious diseases. While the indiscriminant use of broad spectrum antibiotics is a significant contributing factor, a more fundamental problem exists. Diagnostic microbiology test results have historically been available too late to be useful. This is, in part, due to the nature of the test methods and in part due to workflow practices in the laboratory. Thus, patients remain on empiric treatments that are frequently ineffective or unnecessarily too broad spectrum1,2. Microscopy and bacterial cultures are mainstays in the microbiology lab, using techniques developed more than 100 years ago. Although microbiologists speak with pride about the ‘art' of their science, the clinical value of the diagnostic tests is frequently lost because of the delays in reporting results with these ‘traditional' approaches. Fortunately, the practice of clinical microbiology is undergoing a dramatic transformation with the introduction of molecular diagnostics, primarily for rapid diagnosis of infections caused by viruses and difficult to grow bacteria, MALDI-TOF mass spectrometry for identification of bacteria, mycobacteria and fungi, and automation of all practices in bacteriology.

scholarly journals Laboratory automation —some perspectives on the challenges in the implementation of the technology in pharmaceutical development

1998 ◽  
Vol 20 (4) ◽  
pp. 111-115 ◽  
Author(s):  
Nigel North ◽  
Simon Smith
Keyword(s):  
Drug Product ◽  
Clinical Information ◽  
Pharmaceutical Products ◽  
Successful Implementation ◽  
Laboratory Automation ◽  
Stability Studies ◽  
Product Analysis ◽  
Pharmaceutical Development ◽  
The Stability ◽  
Product Team

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options.

Stability Testing of Pharmaceutical Products

2021 ◽  
pp. 317-328
Author(s):  
Yashpal Singh Chauhan ◽  
Ravi Nex ◽  
Ghanshyam Sevak ◽  
Mahendra Singh Rathore
Keyword(s):  
Pharmaceutical Products ◽  
Test Methods ◽  
Pharmaceutical Product ◽  
Stability Test ◽  
World Health ◽  
Stability Testing ◽  
Container Closure ◽  
The Stability ◽  
Main Components ◽  
Health Organization

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

scholarly journals Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan

2020 ◽  
Vol 17 (13) ◽  
pp. 4748 ◽  
Author(s):  
Keigo Sato ◽  
Kota Kodama ◽  
Shintaro Sengoku
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Quality Standard ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Product Categories ◽  
Adoption And Implementation ◽  
Key Characteristics ◽  
Key Driver ◽  
A Company

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company’s adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company’s manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.

scholarly journals APAKAH AUDIT LAPORAN KEUANGAN MENGURANGI SUAP?

2019 ◽  
Vol 16 (4) ◽  
pp. 536-542
Author(s):  
Stevani Kurniawati Lestari Galamba ◽  
Wehelmina Theresia Patric Nggebu
Keyword(s):  
World Bank ◽  
Secondary Data ◽  
Test Methods ◽  
T Test ◽  
Chi Square ◽  
Financial Report ◽  
The World Bank ◽  
The World ◽  
Enterprise Survey ◽  
A Company

Audit financial report is the most important thing in a company. The function is to measure a financial report of a company whether it has fulfilled the standard and characteristic in arranging the financial report. The purpose of the report is to know the use of audit financial report in the company can reduce the bribery practice of government officials. Chi square test and T-test methods were used in this research. The purpose of using this research is to know the relation between variables which is the relation of audit financial report toward the bribe practice in the company. Secondary data from the world bank Indonesia enterprise survey in 2009 is used as the source of data. The results of the research showed that the company that has done the audit financial report tended to not involved in bribe practice.   Audit laporan keuangan adalah hal yang sangat penting dalam suatu perusahan dimana audit laporan keuangan berfungsi untuk menilai suatu laporan keuangan perusahaan telah memenuhi standar dan karakteristik dalam penyusunan laporan keuangan. Penelitian ini bertujuan untuk ingin mengetahui apakah dengan adanya audit laporan keuangan dalam suatu perusahaan dapat mengurangi praktik suap di kalangan pejabat pemerintah. Metode yang digunakan pada penelitian ini menggunakan uji chi square danuji T-test. uji  chi square dan uji  T-test bertujuan untuk mengetahui antar hubungan variabel, hubungan antar variabel dalam penelitian ini yaitu hubungan antara audit laporan keuangan terhadap tindakan suap dalam suatu perusahaan. Sumber data yang digunakan dalam penelitian ini yaitu data sekunder yang diperoleh dari The World Bank Indonesia Enterprise Survey yang dilakukan pada tahun 2009. Hasil penelitian ini menunjukan bahwa perusahaan yang telah melakukan audit atas laporan keuangan cenderung tidak terlibat dalam tindakan suap.

scholarly journals Ticking time bomb: Poorly managed product safety

1969 ◽  
Vol 12 (4) ◽  
Author(s):  
Greg Meline ◽  
Chris Albani
Keyword(s):  
Medical Devices ◽  
Safety Management ◽  
Safety Data ◽  
Pharmaceutical Products ◽  
Data Handling ◽  
Safety Issues ◽  
Handling Practices ◽  
High Level ◽  
A Company

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) – starting early on in clinical development – is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area – from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing – pharmacovigilance.

scholarly journals General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines

2018 ◽  
Vol 6 (2) ◽  
pp. 59-66
Author(s):  
Jyothshna Devi Katamreddy ◽  
Prathyusha Jeeva
Keyword(s):  
Regulatory Authority ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Review Article ◽  
Marketing Authorization ◽  
Expiry Date ◽  
Legal Entity ◽  
Process Outcomes ◽  
A Company

The review article is only for brief idea about the Marketing Authorization Transfers in few of ASEAN region. Whatever the data here I have been provided is according to my knowledge and study depends on healthy authorities/regulatory authorities sometimes requirements also may change. A Marketing Authorization Transfer is may be necessary to a company selling their product rights to another company it’s like acquisition. In Order to transfer any kind of Pharmaceutical Products in ASEAN region from one MAH to other MAH that particular product must have a Marketing Authorization Transfer issued by the competent health/Regulatory Authority. This MAT is issued to a legal entity called MAT.  It is a procedure by which the MA is transferred from the Old MAH to New MAH which is a different legal entity. The MA holder is completing responsibility for the life of the pharmaceutical product including all technical development and further alterations. The MAT process outcomes in the original MAH rights and responsibilities concerning the specific pharmaceutical product to be transferred to the New MAH on a specific date on which the transfer is stimulated. According to dossier all the parameters would be present. The expiry date is same and therefore, if applicable, the date by which it has to be renewed in order to remain legal. If any obligations are applicable (post authorization): PSUR, follow-up measures and special commitments.

scholarly journals A REVIEW ON STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

2020 ◽  
pp. 3-9
Author(s):  
ZOTHANPUII F ◽  
RAJESH R ◽  
SELVAKUMAR K
Keyword(s):  
Pharmaceutical Products ◽  
Test Methods ◽  
Pharmaceutical Product ◽  
Stability Test ◽  
World Health ◽  
Stability Testing ◽  
Container Closure ◽  
The Stability ◽  
Main Components ◽  
Health Organization

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

scholarly journals Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods

2019 ◽  
Vol 9 (3) ◽  
pp. 153-161
Author(s):  
Yu. R. Biglova ◽  
N. V. Gadasina ◽  
T. N. Bokovikova ◽  
E. L. Kovaleva ◽  
S. A. Nemykina ◽  
...  
Keyword(s):  
Methodological Approach ◽  
Pharmaceutical Products ◽  
Test Methods ◽  
Emission Spectrometry ◽  
Trace Impurities ◽  
Specific Test ◽  
Pharmaceutical Substances ◽  
Biological Tests

One of the prerequisites of efficacy and safety of finished pharmaceutical products is the quality of pharmaceutical substances used in their production. Criteria of assessment of pharmaceutical substance purity are determined by the substance composition and production technology, as well as by specific aspects of the finished pharmaceutical product production and use. It is necessary to control the content of nonspecific organic and inorganic impurities, impurities of microbial origin, and residual solvents. The aim of the study was to analyse characteristics of test methods used to determine nonspecific impurities in pharmaceutical substances. The State Pharmacopoeia of the Russian Federation describes various chemical, physical, physicochemical and biological tests for the analysis of nonspecific impurities. Determination of inorganic cations and anions usually includes comparison of test solutions with solutions of the corresponding reference standards, or checking the absence of a positive reaction in the test solution. Quantitative analysis of trace impurities largely relies on highly specific and sensitive test methods, such as atomic absorption spectrometry, atomic emission spectrometry and inductively coupled plasma mass spectrometry. The content of residual organic solvents is determined by gas chromatography or high-performance liquid chromatography. The purity and safety of pharmaceutical substances are ensured by biological tests: “Microbial quality”, “Sterility”, “Pyrogenicity”, “Bacterial endotoxins”. Specific characteristics of test methods used for determination of the content of nonspecific impurities in various pharmaceutical substances depend on physicochemical properties of the tested substances, toxicity of the analysed impurities, and content limits. The results of the study make it possible to formulate a methodological approach to the development of criteria for assessing the quality of pharmaceutical substances. This approach includes mandatory compliance with the basic principles of substance standardisation, as well as case-by-case selection of quality parameters, specific test conditions and content limits for impurities.

Sign in / Sign up

Export Citation Format

Share Document