Regulatory landscape analysis of Myanmar Food and Drug Administration based on the World Health Organization Global benchmarking tool [PDF]
Regulatory authorities play significant roles for ensuring quality, safety, and efficacy of pharmaceutical and health products. However, most of the national regulatory authorities in low- and middle-income countries encounter many challenges such as ...
Ei Ei Chaw +2 more
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Quality Control Tests and Acceptance Criteria of Diagnostic Radiopharmaceuticals
Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to ...
Jun Young Park
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Large-scale production of lentiviral vector in a closed system hollow fiber bioreactor
Lentiviral vectors are widely used in the field of gene therapy as an effective method for permanent gene delivery. While current methods of producing small scale vector batches for research purposes depend largely on culture flasks, the emergence and ...
Jonathan Sheu +7 more
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Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)
Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of
A. P. Meshkovskiy +7 more
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Brazilian Artisanal Cheeses: Diversity, Microbiological Safety, and Challenges for the Sector
Artisanal cheeses made with raw milk are highly appreciated products in Brazil. Most of these cheeses are produced in small facilities across different production regions in the country, some of which have been granted a protected designation of origin ...
Ana Paulina Arellano Pineda +4 more
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Pelatihan Good Manufacturing Practice (GMP) pada Usaha Pangan Binaan Universitas Andalas
Food business is a very promising, but the products must be safe and worth buying. Good manufacturing practices (GMP) are production practices which considering various aspects, such as preventing food contamination during the production process, and ...
Tivany Edwin +4 more
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Evaluation andreflection on the good donor practice
Blood donors, as the core of blood collection and supply system, can greatly ensure blood safety and meet clinical demands with effective management. Good donor practice (GDP) is based on the cooperation of multiple departments by multiple methods.
Yan QIU, Jiang LIU
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Good Manufacturing Practice (GMP) guidelines for virgin olive oil production
This paper presents GMP guidelines for the production of virgin olive oil. Standard procedures and conditions are indicated for olive production, harvesting, transportation and storage, for oil manufacture, storage and packaging, for buildings, process ...
Christos Petrakis
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Mesenchymal stromal cells (MSCs) isolated from bone marrow (BM-MSCs) are considered advanced therapy medicinal products (ATMPs) and need to be produced according to good manufacturing practice (GMP) in their clinical use. Human platelet lysate (HPL) is a
Katia Mareschi +9 more
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Good control practices underlined by an on-line fuzzy control database
In the olive oil trade, control systems that automate extraction processes, cutting production costs and increasing processing capacity without losing quality, are always desirable.
R. Aparicio +3 more
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