good manufacturing practices
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Author(s):  
Irasema Vargas-Arispuro ◽  
Miguel Ángel Martínez-Téllez ◽  
Hilda Karina Sáenz-Hidalgo ◽  
Gustavo Mora-Aguilera ◽  
Nuvia Orduño-Cruz ◽  
...  

<p>Although the SARS-CoV-2 virus can survive in various environments for 28 days or more, and that the virus dispersion by microdroplets in the air can be a risk of contagion, there is no evidence that food carries it. However, the authorities have recommended measures in the handling of food, to avoid the possible spread of the disease through it or its packaging. In addition, current certification models such as ISO 22000 and Good Manufacturing Practices have generated a culture of prevention and food safety also applicable to the SARS-CoV-2 risk.</p>


Author(s):  
Gursaran P. Talwar ◽  
Jagdish C. Gupta ◽  
Shilpi Purswani ◽  
Hemant K. Vyas ◽  
Kripa N. Nand ◽  
...  

This article is a tribute and homage to Gerard Chaouat who invited me to contribute this article. My years in France have remained very memorable to me. Reviewed briefly is the vaccine that was made against human chorionic gonadotropin (hCG) to prevent unwanted pregnancy in sexually active women. It has now been developed as a genetically engineered recombinant vaccine and passed onto industry for its production under good manufacturing practices (GMP) conditions for confirmatory trials. The trials have received the approval of the Drugs Controller General of India. The trials have started but have been interrupted by the coronavirus disease 2019 (COVID-19) pandemic. This vaccine is likely to have another highly beneficial application in the treatment of cancers expressing ectopically hCG.


2021 ◽  
Vol 16 (2) ◽  
pp. 83
Author(s):  
Yusma Yennie ◽  
Gunawan Gunawan ◽  
Farida Ariyani

Listeria monocytogenes adalah salah satu bakteri patogen yang dapat menyebabkan penyakit bawaan pangan. Penolakan ekspor produk udang beku Indonesia karena kontaminasi L. monocytogenes masih terjadi yang berdampak pada kerugian material bagi pelaku usaha. Tujuan penelitian ini adalah untuk mengetahui prevalensi dan tingkat kontaminasi L. monocytogenes pada produk udang beku untuk pasar ekspor. Sampel yang diambil merupakan udang segar dari tambak dan bahan baku dari bagian penerimaan di Unit Pengolahan Ikan (UPI) serta udang beku sebagai produk akhir UPI, dengan menerapkan sistem ketertelusuran. Lokasi penelitian adalah Sumatra Utara (Medan), DKI Jakarta, Jawa Timur (Surabaya dan Banyuwangi), dan Sulawesi Selatan (Makassar). Identifikasi dan enumerasi L. monocytogenes dilakukan dengan metode MPN-PCR dengan target gen hlyA (~456bp). Prevalensi L. monocytogenes pada udang vaname secara keseluruhan sebesar 6,7% (9/135 sampel), dengan prevalensi di masing-masing titik pengambilan sampel berturut-turut 6,1% di tambak, 9,6% di bahan baku, dan 4% di produk akhir, yang merupakan sampel udang dari batch yang sama. Tingkat kontaminasi L. monocytogenes pada sampel udang vaname berkisar 6,1-1.100 APM/g. Persyaratan L. monocytogenes pada bahan pangan adalah negatif/25g, sehingga sampel udang yang terkontaminasi L. monocytogenes tersebut tidak memenuhi persyaratan sebagai pangan yang aman untuk dikonsumsi berdasarkan regulasi yang berlaku di Indonesia maupun di negara lain. Kontaminasi L. monocytogenes pada udang beku kemungkinan berasal dari tambak ataupun lingkungan pengolahan. Penerapan Good Aquaculture Practices (GAP) di lingkungan tambak udang, serta Hazard Analysis Critical Control Point (HACCP) dan Good Manufacturing Practices (GMP) di UPI perlu dilakukan dengan benar sebagai upaya pengendalian kontaminasi L. monocytogenes. Selain itu, perlu dilakukan kajian lebih lanjut mengenai sumber dan titik kritis kontaminasi L. monocytogenes di sepanjang rantai pengolahan udang beku mulai dari tambak sampai produk akhir.ABSTRACTListeria monocytogenes is pathogenic bacteria that can cause foodborne illness. Rejection of frozen shrimp exports due to L. monocytogenes contamination still occurs and causes economical losses for the industries. The objective of this study was to determine the prevalence and the level of L. monocytogenes contamination in frozen shrimp for export markets. Samples collected were fresh shrimp from shrimp culture and raw material from the receiving point of fish processing plants (UPI), and frozen shrimp as the end product, by implementing a traceability system. Study locations were in North Sumatra (Medan), Special Capital Region of Jakarta, East Java (Surabaya dan Banyuwangi), and South Sulawesi (Makassar). Identification and enumeration of L. monocytogenes were carried out using the MPN-PCR method with the target gene hlyA (~456bp). The prevalence of L. monocytogenes in vanname shrimp was 6.7% (9 out of 135 samples), where 6.1%, 9.6%, and 4% of the prevalence were found in samples from shrimp culture, raw material, and end product, respectively. These samples were from the same batch. The contamination level ranged from 6.1 to 1,100 MPN/g. L. monocytogenes in food should be negative/25g, thus the contaminated samples do not meet requirements as safe for human consumption based on food regulation in Indonesia and other countries. Findings from this study suggested that shrimp culture or fish processing environment are potential sources of L. monocytogenes contamination in frozen shrimp. Therefore, the implementation of Good Aquaculture Practices (GAP) in shrimp culture environment, as well as Hazard Analysis Critical Control Point (HACCP) and Good Manufacturing Practices (GMP) in shrimp processing plant are necessary to control L. monocytogenes contamination. Further studies regarding the sources and critical points of L. monocytogenes contamination throughout the processing of frozen shrimp from shrimp culture to end product are also needed.


2021 ◽  
Vol 8 ◽  
Author(s):  
Laura Righetti ◽  
Chiara Dall'Asta ◽  
Renato Bruni

Thirty-seven red yeast rice (RYR) food supplements were screened for their mycotoxin and natural statin content. Products included pure RYR capsules and multi-ingredient formulations with standardized amounts of monacolin K (MK), marketed both online and retail in the European Union. In terms of mycotoxins, citrinin (CIT) was found in all the monitored products. As CIT content ranged from 100 to 25100 μg/kg, only four products were compliant with maximum EU levels in force until April 2020, while a single product was compliant with the limit of 100 μg/kg introduced after that date. Four contaminated products were labeled as “citrinin free”. In terms of natural statins, nine products had a lower content vs. label statements (from −30 to −83%), while for 24 a larger MK amount (from 10 to 266%) was noticed. Three products had a negligible MK content and only 19 offered a daily dosage exceeding 10 mg as dictated by the health claim granted by EFSA in the EU. No sample had label values compliant with pharmaceutical Good Manufacturing Practices requirements (95–105% content of active constituent). Variable, but small amounts of simvastatin (0.1–7.5 μg per daily dose) were found in 30 samples. These results suggest that limited efficacy and reported safety issues may stem from an under-regulated and undercontrolled market, weakening both effectiveness and risk assessment evaluations.


2021 ◽  
Author(s):  
Ramy Harik ◽  
Joseph Elias Khoury

The objective of Manufacturing versus Corruption: Who Wins? is to use scientific methodologies and recommendations to motivate young people to participate in rendering the manufacturing ecosystem successful, by creating a socio-political stability amongst communities, counties, states, and nations in an unprecedented way. This book presents the reader with a practical approach and understanding of key scientific, industrial & managerial concepts that constitute a common policy narrative to be embraced, implemented, and executed across all governmental sectors. As a tool for policy makers, the authors demonstrate the need for a digital manufacturing economy grounded in complete transparency. With over 50 years of experience in engineering and manufacturing, Ramy Harik and Joseph Khoury are on a mission to bring together science, economics, technology, and policy making so all work in tandem for the greater good. Topics include digital manufacturing economies, manufacturing ring, importance of infrastructure and power for successful manufacturing, networks and internet, manufacturing policies, economic policies, education systems, water, importance of data in the manufacturing process, good manufacturing practices, and free-market manufacturing.


Author(s):  
Babeker AM ◽  
Ahmed AI ◽  
Ahmed AR ◽  
Ebrahiem Mohammed Alhadi

The present study was conducted in Sudan Sugar industry factories (Kenana, White Nile, Assalaya, Sennar, Guneid, and New Halfa) during the production season of 2017. The study aimed to evaluate the existing Assessment of the extent of implementing the Good Manufacturing Practices (GMPs) and Hazard Analysis Critical Control Point System (HACCP) by Sudanese sugar factories with reference to FSMS of the ISO 22000: 2005. The data were collected using ISO 22000 checklist and direct interviews. Likert Five-Point Scale was used in scoring the checklist statement and the arithmetic mean was obtained. The result showed that the Good Manufacturing Practices were varied between major deficiencies in White Nile, Assalaya, Sennar, and New Halfa due to score less than (3.6 points) and non-compliance in Kenana and Guneid due to score less than (2.6 points); the Sanitation Standard Operation Procedures (SSOP) assessed as major deficiencies in (Assalaya and Sennar) and minor deficiencies in (White Nile and New Halfa) due to score less than (5points). Moreover, the Hazard Analysis and Critical Control Points System revealed that it was varied between non-compliance in (Kenana, White Nile, and Guneid) and not applicable in (Assalaya, Sennar and New Halfa) due to score less than (1.8 points). Interestingly, the Sudanese sugar industries take all quality control characteristics from cane production to sugar production carefully, but unfortunately don’t care about any food safety systems. Lack of top management commitment and involvement and lack of government support represent the main constraints and Barriers of implementing food safety systems in Sudanese sugar companies. The study recommendations that the Sudanese Sugar Industry needs to establish proper quality assurance laboratories to help in monitoring the quality and safety of raw materials and end productions.


2021 ◽  
Vol 40 (3_suppl) ◽  
pp. 53S-76S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.


2021 ◽  
Vol 32 (10) ◽  
pp. 11-17
Author(s):  
Véronique Gibon ◽  
◽  
Wim De Greyt

Mineral oils are widespread food contaminants, and edible oils, like many other foodstuffs, are often contaminated. The lack of robust analytical methods and proper toxicological evaluation make it difficult to set a tolerance level. • The best way to avoid mineral oil contamination is to prevent it by complying with good manufacturing practices, and the best solution to reducing mineral oil contamination in edible oils is through refining, especially during deodorization. This paper gives an overview of contamination sources, levels in some edible oils, regulatory aspects, analytical methods, and strategies for mitigation during refining.


Author(s):  
Eleonora Di Piazza ◽  
Elisabetta Pandolfi ◽  
Ilaria Cacciotti ◽  
Andrea Del Fattore ◽  
Alberto Eugenio Tozzi ◽  
...  

Bioprinting is an emerging additive manufacturing technique which shows an outstanding potential for shaping customized functional substitutes for tissue engineering. Its introduction into the clinical space in order to replace injured organs could ideally overcome the limitations faced with allografts. Presently, even though there have been years of prolific research in the field, there is a wide gap to bridge in order to bring bioprinting from “bench to bedside”. This is due to the fact that bioprinted designs have not yet reached the complexity required for clinical use, nor have clear GMP (good manufacturing practices) rules or precise regulatory guidelines been established. This review provides an overview of some of the most recent and remarkable achievements for skin, heart, pancreas and cartilage bioprinting breakthroughs while highlighting the critical shortcomings for each tissue type which is keeping this technique from becoming widespread reality.


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