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Good manufacturing practice

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https://www.readbyqxmd.com/read/28929177/-falsified-pharmaceutical-products-legislative-measures-in-the-european-union-and-in-germany
#1
REVIEW
Burkhard Sträter
Falsified pharmaceutical products are multi-faceted and driven by great criminal power. The health risks for patients who are frequently very seriously ill are high. The problem in Europe has been recognised. The European Union has created statutory requirements that considerably improve and tighten the system of manufacturing, distribution and documentation, and of pharmaceutical product authorisations. The traceability of each package via safety features is strengthened and made binding by detailed delegated legislation...
September 19, 2017: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/28928292/elastomer-change-out-justification-for-minimizing-the-removal-of-elastomers-in-order-to-prevent-cross-contamination-in-a-multiproduct-facility
#2
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validation, which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an Elastomer Change Out (ECO) should be considered as a segment of an overall changeover assessment. Lifecycle systems (e.g. Preventive Maintenance (PM), Cleanability Coupon Testing, Good Engineering Practices, etc...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28923044/cost-benefit-of-investment-on-quality-in-pharmaceutical-manufacturing-who-gmp-pre-and-post-certification-of-a-nigerian-pharmaceutical-manufacturer
#3
Chimezie Anyakora, Obinna Ekwunife, Faith Alozie, Mopa Esuga, Jonathan Ukwuru, Steve Onya, Jude Nwokike
BACKGROUND: Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study...
September 18, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28916916/investigating-baseline-red-meat-slaughter-operator-capacity-and-directions-for-development-in-lao-pdr
#4
Joanne C Thomas, James R Young, Kathrin Schemann, Phaivanh Chankhamthong, Syseng Khounsy, Sonevilay Nampanya, Peter A Windsor, Russell D Bush
A study of operator knowledge, attitudes and practices (KAP) in red meat slaughter premise operations in northern Laos was conducted and compared with international best practice, to inform future industry development. The survey interviewed 68 (of 94 possible participants) employees from all ten commercial slaughter premises in six districts in three northern Laos provinces. This was supported by observations of slaughter premises, processes and the conduct of personnel. Descriptive analysis and linear regression modelling identified significant KAP predictor factors, and a gap analysis supported or rejected inferences from the generally low KAP scores for human and animal health, animal welfare, good manufacturing practices (GMP), work conditions and economics...
September 15, 2017: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/28890324/direct-head-to-head-evaluation-of-recombinant-adeno-associated-viral-vectors-manufactured-in-human-versus-insect-cells
#5
Oleksandr Kondratov, Damien Marsic, Sean M Crosson, Hector R Mendez-Gomez, Oleksandr Moskalenko, Mario Mietzsch, Regine Heilbronn, Jonathan R Allison, Kari B Green, Mavis Agbandje-McKenna, Sergei Zolotukhin
The major drawback of the Baculovirus/Sf9 system for recombinant adeno-associated viral (rAAV) manufacturing is that most of the Bac-derived rAAV vector serotypes, with few exceptions, demonstrate altered capsid compositions and lower biological potencies. Here, we describe a new insect cell-based production platform utilizing attenuated Kozak sequence and a leaky ribosome scanning to achieve a serotype-specific modulation of AAV capsid proteins stoichiometry. By way of example, rAAV5 and rAAV9 were produced and comprehensively characterized side by side with HEK293-derived vectors...
August 10, 2017: Molecular Therapy: the Journal of the American Society of Gene Therapy
https://www.readbyqxmd.com/read/28887912/safety-profile-of-good-manufacturing-practice-manufactured-interferon-%C3%AE-primed-mesenchymal-stem-stromal-cells-for-clinical-trials
#6
Adam J Guess, Beth Daneault, Rongzhang Wang, Hillary Bradbury, Krista M D La Perle, James Fitch, Sheri L Hedrick, Elizabeth Hamelberg, Caroline Astbury, Peter White, Kathleen Overolt, Hemalatha Rangarajan, Rolla Abu-Arja, Steven M Devine, Satoru Otsuru, Massimo Dominici, Lynn O'Donnell, Edwin M Horwitz
Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule...
September 9, 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28862712/enhanced-liver-fibrosis-test-as-a-reliable-tool-for-assessing-fibrosis-in-nonalcoholic-fatty-liver-disease-in-a-clinical-setting
#7
Luca Miele, Teresa De Michele, Giuseppe Marrone, Maria Antonietta Isgrò, Umberto Basile, Consuelo Cefalo, Marco Biolato, Fabio Maria Vecchio, Gian Lodovico Rapaccini, Antonio Gasbarrini, Cecilia Zuppi, Antonio Grieco
BACKGROUND: Liver fibrosis is the main determinant and predictor of the clinical course of nonalcoholic fatty liver disease (NAFLD). To date, a liver biopsy is still considered the gold standard for staging fibrosis. The aim of this study was to investigate the diagnostic accuracy of the commercial enhanced liver fibrosis (ELF) test manufacturer's cutoff value (≥9.8) in identifying severe fibrosis for adult patients with histologically confirmed NAFLD. METHODS: We tested the ELF test in a clinical practice, prospective cohort of 82 consecutive patients who consecutively underwent percutaneous liver biopsy...
August 28, 2017: International Journal of Biological Markers
https://www.readbyqxmd.com/read/28860488/assessment-of-selected-media-supplements-to-improve-f-hn-lentiviral-vector-production-yields
#8
Jean-François Gélinas, Lee A Davies, Deborah R Gill, Stephen C Hyde
The development of lentiviral-based therapeutics is challenged by the high cost of current Good Manufacturing Practices (cGMP) production. Lentiviruses are enveloped viruses that capture a portion of the host cell membrane during budding, which then constitutes part of the virus particle. This process might lead to lipid and protein depletion in the cell membrane and affect cell viability. Furthermore, growth in suspension also causes stresses that can affect virus production yields. To assess the impact of these issues, selected supplements (Cholesterol Lipid Concentrate, Chemically Defined Lipid Concentrate, Lipid Mixture 1, Gelatin Peptone N3, N-Acetyl-L-Cysteine and Pluronic F-68) were assayed in order to improve production yields in a transient transfection production of a Sendai virus F/HN-pseudotyped HIV-1-based third generation lentiviral vector in FreeStyle 293 (serum-free media) in suspension...
August 31, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28858290/generation-of-high-purity-human-ventral-midbrain-dopaminergic-progenitors-for-in-vitro-maturation-and-intracerebral-transplantation
#9
Sara Nolbrant, Andreas Heuer, Malin Parmar, Agnete Kirkeby
Generation of precisely patterned neural cells from human pluripotent stem cells (hPSCs) is instrumental in developing disease models and stem cell therapies. Here, we provide a detailed 16-d protocol for obtaining high-purity ventral midbrain (VM) dopamine (DA) progenitors for intracerebral transplantation into animal models and for in vitro maturation into neurons. We have successfully transplanted such cells into the rat; however, in principle, the cells can be used for transplantation into any animal model, and the protocol is designed to also be compatible with clinical transplantation into humans...
September 2017: Nature Protocols
https://www.readbyqxmd.com/read/28854594/transparent-collaboration-between-industry-and-academia-can-serve-unmet-patient-need-and-contribute-to-reproductive-public-health
#10
Thomas D'Hooghe
The pharmaceutical and device industry has greatly contributed to diagnostic and therapeutic approaches in reproductive medicine in a very highly regulated environment, ensuring that development and manufacturing follow the highest standards. In spite of these achievements, collaboration between industry and physicians/academia is often presented in a negative context. However, today more than ever, partnership between industry and academia is needed to shorten the timeline between innovation and application, and to achieve faster access to better diagnostics, drugs and devices for the benefit of patients and society, based on complementary knowledge, skills and expertise...
August 1, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28839314/reusing-dialyzer-in-low-income-countries-a-good-cost-saving-tactic-with-complex-ethics
#11
Murtaza Fakhruddin Dhrolia, Salman Imtiaz, Ruqaya Qureshi, Aasim Ahmed
Despite almost universal practice of dialyzer reuse from the earliest days of haemodialysis, reusing dialyzer always remains a controversial issue and several ethical concerns have been raised. Some of the important are safety of reuse over single use, informed consent of the patient, conflict of interest on the part of physician or manufacturer, fiscal responsibility and environmental stewardship. Indeed, at the beginning of this century, there was a drastic shift of practice in favour of single use in developed countries due to availability of biocompatible haemodialyzers, at favourable price...
August 2017: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/28829937/using-cad-cam-modified-correlation-mode-to-produce-laminate-veneers-a-six-month-case-report
#12
Fsf de Siqueira, Afm Cardenas, Y L Gruber, C Kose, Y M Pupo, G M Gomes, Omm Gomes, J C Gomes
The expectation of an esthetically harmonious smile increases the level of difficulty when treating patients. Laminate veneers stand out as a treatment option for cosmetic rehabilitation in clinical practice, as they are a more conservative procedure and mimic dental structures. These laminate veneers are generally made with different techniques; the most common requires an impression of the prepared tooth, an impression antagonist, fabrication models, and extensive laboratory time. The computer-aided design/computer-aided manufacturing (CAD/CAM) system optimizes the fabrication of prosthetic structures, reducing chairside time and promoting good esthetic results...
September 2017: Operative Dentistry
https://www.readbyqxmd.com/read/28828392/thermal-stability-as-a-determinant-of-aav-serotype-identity
#13
Antonette Bennett, Saajan Patel, Mario Mietzsch, Ariana Jose, Bridget Lins-Austin, Jennifer C Yu, Brian Bothner, Robert McKenna, Mavis Agbandje-McKenna
Currently, there are over 150 ongoing clinical trials utilizing adeno-associated viruses (AAVs) to target various genetic diseases, including hemophilia (AAV2 and AAV8), congenital heart failure (AAV1 and AAV6), cystic fibrosis (AAV2), rheumatoid arthritis (AAV2), and Batten disease (AAVrh.10). Prior to patient administration, AAV vectors must have their serotype, concentration, purity, and stability confirmed. Here, we report the application of differential scanning fluorimetry (DSF) as a good manufacturing practice (GMP) capable of determining the melting temperature (Tm) for AAV serotype identification...
September 15, 2017: Molecular Therapy. Methods & Clinical Development
https://www.readbyqxmd.com/read/28812871/high-performance-porous-molybdenum-oxynitride-based-fiber-supercapacitors
#14
Dan Ruan, Rui Lin, Kui Jiang, Xiang Yu, Yaofeng Zhu, Yaqin Fu, Zilong Wang, He Yan, Wenjie Mai
Scalable manufacturing of flexible, fiber-shaped energy-storage devices has enabled great technological advances in wearable and portable technology. Replacing inefficient oxides with inexpensive and high-performance oxynitrides with more favorable three-dimensional (3D) structures is critical if the practical applications of these technologies are to be realized. Here, we developed a facile and controllable approach for the synthesis of 3D porous micropillars of molybdenum oxynitride (MON), which exhibit high conductivity, robust stability, and excellent energy-storage properties...
August 25, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28807013/microneedle-physical-contact-as-a-therapeutic-for-abnormal-scars
#15
David C Yeo, Elizabeth R Balmayor, Jan-Thorsten Schantz, Chenjie Xu
BACKGROUND: Abnormal (keloid and hypertrophic) scars are a significant affliction with no satisfactory single modality therapy to-date. Available options are often ineffective, painful, potentially hazardous, and require healthcare personnel involvement. Herein a self-administered microneedle device based on drug-free physical contact for inhibiting abnormal scars is reported. Its therapeutic activity through microneedle contact eliminates hazards associated with toxic anti-scarring drugs while self-treatment enables administration flexibility...
August 14, 2017: European Journal of Medical Research
https://www.readbyqxmd.com/read/28797612/decentralized-manufacturing-of-cell-and-gene-therapies-overcoming-challenges-and-identifying-opportunities
#16
REVIEW
Richard P Harrison, Steven Ruck, Nicholas Medcalf, Qasim A Rafiq
Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions...
August 7, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28797469/multivariate-statistical-process-control-in-product-quality-review-assessment%C3%A2-%C3%A2-a-case-study
#17
M Kharbach, Y Cherrah, Y Vander Heyden, A Bouklouze
According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for the quality standards to determine the need of any change in specification or manufacturing of drug products...
August 7, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28771040/validation-of-thermal-lethality-against-salmonella-enterica-in-poultry-offal-during-rendering
#18
Amie-Marie Jones-Ibarra, Gary R Acuff, Christine Z Alvarado, T Matthew Taylor
Recent outbreaks of human disease following contact with companion animal foods cross-contaminated with enteric pathogens, such as Salmonella enterica, have resulted in increased concern regarding the microbiological safety of animal foods. Additionally, the U.S. Food and Drug Administration Food Safety Modernization Act and its implementing rules have stipulated the implementation of current good manufacturing practices and food safety preventive controls for livestock and companion animal foods. Animal foods and feeds are sometimes formulated to include thermally rendered animal by-product meals...
September 2017: Journal of Food Protection
https://www.readbyqxmd.com/read/28763564/the-accuracy-of-static-pressure-measurement-with-water-filled-urodynamic-systems
#19
Andrew Gammie
AIMS: To quantify the inaccuracy of pressure measurement by water-filled systems, with a view to recommending better practice. METHODS: Papers examining quality of measurements were reviewed, and standards documents examined. Technical data from manufacturers were gathered and summarized. Measurements were made on two different urodynamic systems. Individual inaccuracies were combined using the root sum of squares method. RESULTS: The total inaccuracy in measurement may reach up to 9...
August 1, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28761170/intravenous-infusion-of-human-bone-marrow-mesenchymal-stromal-cells-promotes-functional-recovery-and-neuroplasticity-after-ischemic-stroke-in-mice
#20
Eliana Sammali, Claudia Alia, Gloria Vegliante, Valentina Colombo, Nadia Giordano, Francesca Pischiutta, Giorgio B Boncoraglio, Mario Barilani, Lorenza Lazzari, Matteo Caleo, Maria-Grazia De Simoni, Giuseppe Gaipa, Giuseppe Citerio, Elisa R Zanier
Transplantation of human bone marrow mesenchymal stromal cells (hBM-MSC) promotes functional recovery after stroke in animal models, but the mechanisms underlying these effects remain incompletely understood. We tested the efficacy of Good Manufacturing Practices (GMP) compliant hBM-MSC, injected intravenously 3.5 hours after injury in mice subjected to transient middle cerebral artery occlusion (tMCAo). We addressed whether hBM-MSC are efficacious and if this efficacy is associated with cortical circuit reorganization using neuroanatomical analysis of GABAergic neurons (parvalbumin; PV-positive cells) and perineuronal nets (PNN), a specialized extracellular matrix structure which acts as an inhibitor of neural plasticity...
July 31, 2017: Scientific Reports
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