Good manufacturing practice
Microbiological Evaluation of Artisanal Food Quality and of Good Manufacturing Practice in Agroindustries of the Far West Region of Santa Catarina, Southern Brazil
... health. Good Manufacturing Practices (GMP) training courses have been used in order to prevent foodborne ...of good manufacturing practice in the far west region of Santa Catarina, ...
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“A Comparative Study: Good Manufacturing Practice (GMP) Requirements for Herbal Products: India & Europe” by Kamli Ankita S, Desai Shuchi M, India.
... The Present study deals with a brief overview of the GMP requirements for herbal products manufactured in India & Europe. Herbal medicine have always played an important role in the primary health care therefore ...
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Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation
... and Good Manufacturing Prac- tice requirements, to be implemented within the process of producing blood products or plasma derived biological drugs by ...ing Good Manufacturing Practice ...
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Validation of analytical methods in compliance with good manufacturing practice: a practical approach
... GMP: Good manufacturing practice; GM-CSF: Granulocyte-macrophage colony- stimulating factor; HS: Human serum; ICH Q2: International conference on harmonization Q2; IL: Interleukin; IQ: Installation ...
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Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks
... Fabrication of cell-based medicinal products for clinical trials should take place in compliance with the principles of GMP, formulated in Commission Directive 2003/94/ EC [25]. Safety aspects represent one of the main ...
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Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal
... Our Nepali case study documents problems with GMP implementation and enforcement due to low regulatory capacity, insufficient training of staff in the pharmaceut- ical industry as well as financial constraints. Nepali ...
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A bioreactor system for the manufacture of a genetically modified Plasmodium falciparum blood stage malaria cell bank for use in a clinical trial
... A process for culturing sufficient volumes of P. falci- parum in tissue culture flasks for in vitro production of Good Manufacturing Practice (GMP) grade blood stage malaria cell banks was recently ...
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Bringing New PET Drugs to Clinical Practice - A Regulatory Perspective
... current good manufacturing practice; CMS: Center for Medicare & Medicaid Services; CT: com- puted tomography; DMF: drug master file; EA: ex- panded access; eIND: exploratory investigational new ...
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Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation
... GMP: Good Manufacturing Practice; HDI: Human Development Index; HIV/AIDS: Human immunodeficiency Virus, Acquired immunodeficiency Syndrome; HLTF: High Level Task Force on Innovative International ...
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Microbial quality control management in industry : approaches for assessing bioburden and community composition
... Fluorescence in situ hybridization US Food Safety and Inspection Service Food Safety Modernization Act Ground calcium carbonate Genomic DNA Good manufacturing practice Glutaraldehyde Haz[r] ...
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Management of retinitis pigmentosa by Wharton’s jelly-derived mesenchymal stem cells: prospective analysis of 1-year results
... The mesenchymal stem cells used in this study were isolated from Wharton’s jelly of the umbilical cord that was collected allogenicly from a single donor with the mother’s consent. The umbilical cord sample was treated ...
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CURRENT GOOD MANUFACTURING GUIDELINES FOR MEDICINAL PRODUCT
... incorporates Good Manufacturing Practice plus other factors outside the scope of this ...a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for ...
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First clinical case report of local microinjection of autologous fat and adipose-derived stromal vascular fraction for perianal fistula in Crohn’s disease
... The surgical procedure requires the performance of two consecutive surgeries on the same day under general anesthesia (Fig. 1). The first surgery consists of lipoas- piration to obtain ADSVF. Adipose tissue was harvested ...
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Immunologic special forces: anti-pathogen cytotoxic T-lymphocyte immunotherapy following hematopoietic stem cell transplantation
... product manufacturing, and uses existing Good Manufacturing Practice-compliant sorting ...for manufacturing of CTLs from pathogen-naïve donors nor for pathogens that induce a poor ...
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Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo controlled, randomised clinical trial of efficacy and safety of cannabidiol (CBD)
... on Good Clinical Practice; CRF : Case Report Form; CRP : C-reactive protein; DASS – 21 : The Depression, Anxiety, Stress Scale; DSMB : Data Safety Monitoring Board; EORTC QLQ-C15-PAL : European Organisation ...
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High-efficiency derivation of human embryonic stem cell lines using a culture system with minimized trophoblast cell proliferation
... GMP: Good manufacturing practice; Hb: Hemoglobin; hESC: Human embryonic stem cell; HFF: Human foreskin fibroblast; ICM: Inner cell mass; iPSC: Induced pluripotent stem cell; IVF: In vitro ...
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Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study
... The HAI-AP toolkit to identify IFDCs consists of fifteen parameters to be fulfilled by a particular FDC under study. The parameters in the toolkit state that the FDC should have a marketing status in different countries, ...
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Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial
... GMP: Good manufacturing practice; GPHCM: Guangdong Provincial Hospital of Chinese Medicine; IF: Isofraxidin; IWRS-CMT: The Interactive Web Response System for Chinese Medicine Trials3; KC: ...
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Documentation and Records: Harmonized GMP Requirements
... contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose intravenous solutions that were not uniformly sterile. The ...
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GMP-compatible and xeno-free cultivation of mesenchymal progenitors derived from human-induced pluripotent stem cells
... Background: Human mesenchymal stem cells are a strong candidate for cell therapies owing to their regenerative potential, paracrine regulatory effects, and immunomodulatory activity. Yet, their scarcity, limited ...
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