Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents [PDF]
Biomaterials and Biosystems, 2021 Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also ...
Clara Sanz-Nogués, Timothy O'Brien
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The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence [PDF]
Frontiers in MedicineIntroductionRegulatory agencies impose stringent legislation and guidelines in the pharmaceutical industry to ensure the safety and quality of medicinal products.
Aisha Al Azawei +5 more
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Exosomes in clinical trial and their production in compliance with good manufacturing practice [PDF]
Tzu Chi Medical Journal, 2020 Exosomes, 60-200-nm extracellular vesicles secreted from cells, have been used as an active pharmaceutical ingredient or drug carrier in disease treatment. Human- and plant-derived exosomes are registered in clinical trials, but more complete reports are
Yu-Shuan Chen +3 more
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An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan [PDF]
Cost Effectiveness and Resource Allocation, 2022 Background Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity.
Rohullah Roien +8 more
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Good Manufacturing Practice (GMP) Compliance for Phage Therapy Medicinal Products [PDF]
Frontiers in Microbiology, 2020 Facing the emergence of difficult-to-treat bacterial infections, the perspective of using bacteriophages has re-gained interest in many countries. In terms of pharmaceutical classification in EU and United States, phages are considered as anti-infectious
Laurent Bretaudeau +4 more
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Evaluating health information provided to kratom consumers by good manufacturing practice-qualified vendors [PDF]
Substance Abuse Treatment, Prevention, and Policy, 2023 Background “Kratom” commonly refers to the botanical Mitragyna speciosa, native to Southeast Asia, which is increasingly used globally for its unique pharmacological effects.
Katherine Hill +5 more
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A Full Good Manufacturing Practice–Compliant Protocol for Corneal Stromal Stem Cell Cultivation [PDF]
Bio-ProtocolCorneal scarring, a significant cause of global blindness, results from various insults, including trauma, infections, and genetic disorders. The conventional treatment to replace scarred corneal tissues includes partial or full-thickness corneal ...
Mithun Santra +8 more
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Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards [PDF]
Journal of Pharmacopuncture, 2021 Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for ...
Ji-Eun Han +6 more
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Good manufacturing practice in low‐ and middle‐income countries: Challenges and solutions for compliance [PDF]
Public Health ChallengesApproximately 2 billion people globally have limited access to essential medicines, particularly those living in low‐ and middle‐income countries (LMICs).
Pelden Chejor +3 more
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Considering Cell Therapy Product “Good Manufacturing Practice” Status [PDF]
Frontiers in Medicine, 2018 Patrick Bedford +3 more
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