Log in

Relevant bibliographies by topics / Good Manufacturing Practice / Journal articles

To see the other types of publications on this topic, follow the link: Good Manufacturing Practice.

Journal articles on the topic 'Good Manufacturing Practice'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 journal articles for your research on the topic 'Good Manufacturing Practice.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.

1

SUGIHARA, M. "Good Manufacturing Practice." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 60, no. 5 (1990): 249–53. http://dx.doi.org/10.4286/ikakikaigaku.60.5_249.

Full text

APA, Harvard, Vancouver, ISO, and other styles

2

Clark, Andrew P. Z., Hong Dixon, Norma L. Cantu, Larry A. Cabell, and Joe A. McDonough. "Good Manufacturing Practice." International Journal of Toxicology 32, no. 4_suppl (2013): 18S—29S. http://dx.doi.org/10.1177/1091581813490204.

Full text

Abstract:

We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1′-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously develope

APA, Harvard, Vancouver, ISO, and other styles

3

Kell, Douglas B., and Bernhard Sonnleitner. "GMP — good modelling practice: an essential component of good manufacturing practice." Trends in Biotechnology 13, no. 11 (1995): 481–92. http://dx.doi.org/10.1016/s0167-7799(00)89006-x.

Full text

APA, Harvard, Vancouver, ISO, and other styles

4

Kerner, B. "Good manufacturing practice and viral safety." Blood Coagulation & Fibrinolysis 6, Sup 2 (1995): S15—S19. http://dx.doi.org/10.1097/00001721-199506002-00004.

Full text

APA, Harvard, Vancouver, ISO, and other styles

5

Shin, Byungchul, and Sangbock Lee. "Suggestion for Good Manufacturing Practice of Radiopharmaceuticals." Journal of the Korean Society of Radiology 7, no. 6 (2013): 397–402. http://dx.doi.org/10.7742/jksr.2013.7.6.397.

Full text

APA, Harvard, Vancouver, ISO, and other styles

6

Vijay, Kumar, Bist Meenu, Banyal Arti, and Patial Kirti. "Golden Rules of Good Manufacturing Practice (GMP)." Journal of Pharma and Drug Regulatory Affairs 1, no. 1 (2019): 30–37. https://doi.org/10.5281/zenodo.2575336.

Full text

Abstract:

<em>The basic rules in any good manufacturing practice (GMP) regulations postulate that the pharmaceutical manufacturer must maintain appropriate documentation and records. Documentation helps to build up a detailed interpretation of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a base for planning what it is going to do in the future. Regulatory evaluators, during their inspections of manufacturing sites, often devote much time on examining a company’s documents and records. Effective documentation boosts the visibility of the quality

APA, Harvard, Vancouver, ISO, and other styles

7

Schmidt, P. "Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory." Accreditation and Quality Assurance 4, no. 4 (1999): 129–32. http://dx.doi.org/10.1007/s007690050332.

Full text

APA, Harvard, Vancouver, ISO, and other styles

8

TANAKA, Hideo. "Good Manufacturing Practice of the Soy Sauce (Part1)." JOURNAL OF THE BREWING SOCIETY OF JAPAN 91, no. 10 (1996): 710–15. http://dx.doi.org/10.6013/jbrewsocjapan1988.91.710.

Full text

APA, Harvard, Vancouver, ISO, and other styles

9

Ertay, Türkan. "Current Good Manufacturing Practice for Radiopharmaceutical Products (GMPR)." Nuclear Medicine Seminars 6, no. 3 (2020): 295–306. http://dx.doi.org/10.4274/nts.galenos.2020.0025.

Full text

APA, Harvard, Vancouver, ISO, and other styles

10

Rampal, Abhimanyu, and S. P. Yamini Kanti. "Good Manufacturing Practice (GMP): History, structure and its significance." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 66–72. http://dx.doi.org/10.22270/ijdra.v8i4.439.

Full text

Abstract:

Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food, Cosmetics, Pharmaceuticals products, Medical Devices & Dietary products should follow these guidelines in order to be sure that their product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories may vary but there is only one aim & that is to prevent any kind of harm that can occur to the final user of the product.

APA, Harvard, Vancouver, ISO, and other styles

11

TANAKA, Hideo. "Good Manufacturing Practice of the Soy Sauce (Part 2)." JOURNAL OF THE BREWING SOCIETY OF JAPAN 91, no. 11 (1996): 783–92. http://dx.doi.org/10.6013/jbrewsocjapan1988.91.783.

Full text

APA, Harvard, Vancouver, ISO, and other styles

12

Tiwari, A., P. Sackett, S. Rehman, and H. Linton. "Good operations practice supervisor profiles in cell-centric manufacturing." International Journal of Production Research 46, no. 15 (2008): 4083–110. http://dx.doi.org/10.1080/00207540601161595.

Full text

APA, Harvard, Vancouver, ISO, and other styles

13

Heir, Robert Stuart. "Good Manufacturing Practice: An Historical Overview and Actual Status." Drug Information Journal 28, no. 4 (1994): 957–63. http://dx.doi.org/10.1177/009286159402800408.

Full text

APA, Harvard, Vancouver, ISO, and other styles

14

Kawamura, Kunio. "Good Manufacturing Practice for Investigational Pharmaceutical Products in Japan." Drug Information Journal 28, no. 4 (1994): 997–1001. http://dx.doi.org/10.1177/009286159402800414.

Full text

APA, Harvard, Vancouver, ISO, and other styles

15

Jokovic, Zora, Goran Jankovic, Slobodan Jankovic, Aleksandar Supurovic, and Vidosav Majstorović. "Quality 4.0 in Digital Manufacturing – Example of Good Practice." Quality Innovation Prosperity 27, no. 2 (2023): 177–207. http://dx.doi.org/10.12776/qip.v27i2.1870.

Full text

Abstract:

Purpose: The ever-evolving market dynamics and the trend toward increased product individualization demand a high degree of adaptability in production management. This calls for novel approaches, such as Industry 4.0 (I4.0), which integrates the Quality 4.0 (Q4.0) model as well. Methodology/Approach: I4.0 builds upon the foundation of digital manufacturing and entails three key dimensions: (i) The employment of advanced digital technologies to enable digital production, (ii) The development of smart products, which incorporate novel production methods and innovative features, and, (iii) The ad

APA, Harvard, Vancouver, ISO, and other styles

16

Poli, Michela, Mauro Quaglierini, Alessandro Zega, et al. "Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations." Applied Sciences 14, no. 4 (2024): 1584. http://dx.doi.org/10.3390/app14041584.

Full text

Abstract:

Risk assessment and management during the entire production process of a radiopharmaceutical are pivotal factors in ensuring drug safety and quality. A methodology of quality risk assessment has been performed by integrating the advice reported in Eudralex, ICHQ, and ISO 9001, and its validity has been evaluated by applying it to real data collected in 21 months of activities of 18F-FDG production at Officina Farmaceutica, CNR-Pisa (Italy) to confirm whether the critical aspects that previously have been identified in the quality risk assessment were effective. The analysis of the results of t

APA, Harvard, Vancouver, ISO, and other styles

17

Satrio, Danang, and Wenti Ayu Sunarjo. "ANALISIS MUTU PRODUK UMKM MELALUI PENERAPAN GOOD MANUFACTURING PRACTICE." Derivatif : Jurnal Manajemen 17, no. 2 (2023): 320–28. https://doi.org/10.24127/jm.v17i2.1854.

Full text

Abstract:

Salah satu upaya untuk mendorong dan mengembangkan industri-industri pengolahan skala kecil agar dapat memiliki mutu baik, aman dikonsumsi, tersedia secara berkesinambungan, dan berdaya saing tinggi secara ekonomis serta sesuai dengan selera masyarakat yaitu dengan mengendalikan proses pengolahan melalui sistem manajemen keamanan pangan berupa program kelayakan dasar berdasarkan konsep program manajemen mutu terpadu yaitu penerapan cara produksi pangan yang baik (CCPB) atauGood Manufacturing Practices(GMP). Tujuan dari penelitian ini adalah untuk Penelitian bertujuan mengidentifikasi penerapan

APA, Harvard, Vancouver, ISO, and other styles

18

Sitepu, Syawal, Yulia Annisa, Raichan Izzati, Siti Shofiya Nasution, Durrah Hayati, and Ida Rosita. "Evaluasi Penerapan Good Manufacturing Practice (GMP) di Industri Kopi (studi kasus UD. XYZ)." Jurnal Ilmiah Mahasiswa Pertanian 9, no. 2 (2024): 106–13. https://doi.org/10.17969/jimfp.v9i2.30335.

Full text

Abstract:

Good Manufacturing Practices (GMP) is a guideline that emphasizes food safety aspects for the Home Industry (IRT) to produce food that is good quality, safe and good for consumption. UD. XYZ is one of the arabica coffee producers located in Takengon, Central Aceh. Coffee processing at UD. XYZ starts from receiving raw materials which are then continued with grinding, washing, drying, and packaging to become green coffee beans that are ready to be distributed and marketed to the public. This study aims to evaluate the implementation of GMP at UD. XYZ. The results showed that UD. XYZ has impleme

APA, Harvard, Vancouver, ISO, and other styles

19

Avani, Reddy Alla, T. Cherian Kevin, Surapaneni Ramya, et al. "ROLE OF LOCAL MANUFACTURERS AND COMPETENT AUTHORITIES IN THE GOOD MANUFACTURING PRACTICE." International Journal of Current Pharmaceutical Review and Research 14, no. 01 (2022): 89–92. https://doi.org/10.5281/zenodo.12666223.

Full text

Abstract:

Good Manufacturing Practice (GMP) is a set of quality control and assurance principles andguidelines that are essential in the manufacturing of pharmaceutical, biotechnological, andmedical device products. GMP ensures that these products are consistently produced andcontrolled according to established quality standards to ensure their safety, efficacy, andquality. Local manufacturers are responsible for understanding and complying with the GMPregulations and guidelines set by the regulatory authorities in their respective countries. Theymust ensure that their manufacturing processes, facilitie

APA, Harvard, Vancouver, ISO, and other styles

20

Shlopak, L. B. "Standards of Good Clinical Practice (GCP)." Spravočnik vrača obŝej praktiki (Journal of Family Medicine), no. 6 (May 28, 2023): 23–28. http://dx.doi.org/10.33920/med-10-2306-03.

Full text

Abstract:

In the Eurasian Economic Union, the unified rules of Good Clinical Practice (GCP) came into force on May 6, 2017. These rules relate primarily to the circulation of medicines, and, along with good manufacturing practice (GMP) and good laboratory practice (GLP), are fundamental in matters of standardizing the quality of medical care for the population. The scope of these rules covers clinical trials of medicines, where the “subject” is an individual, and affects the ethical and moral aspects of conducting such trials [4]. Compliance with these rules is necessary when conducting clinical trials,

APA, Harvard, Vancouver, ISO, and other styles

21

Panovski-Nikoljski, Elena, Aleksandar Petanovski, and Ivo Spiroski. "Analysis of the methods for projection of spaces for good manufacturing practice." South East European Journal of Architecture and Design 2019 (December 29, 2019): 1–6. http://dx.doi.org/10.3889/seejad.2019.10042.

Full text

Abstract:

BACKGROUND: In this Paper we will present the evolution of the best practice for biobanks, the technical and medical standards for collecting, processing and storing, as well as the socio-economic standards for biobank management. AIM: The aim of this Thesis is to analyse and to present the methods for projection of spaces for good manufacturing practice. METHODS: The European Union has adopted guidelines for good manufacturing practice which define the requirements for manufacturing of sterile products. In the following text we will describe the details for determining microbiolog

APA, Harvard, Vancouver, ISO, and other styles

22

Lapele, Sukmawati, Annisa Kesy Garside, Ikhlasul Amallynda, and Mohammad Lukman. "Assessment Model of Halal Good Manufacturing Practice in Bakery SMEs." Industria: Jurnal Teknologi dan Manajemen Agroindustri 13, no. 1 (2024): 14–35. http://dx.doi.org/10.21776/ub.industria.2024.013.01.2.

Full text

Abstract:

Bakery products are in great demand among Indonesians today. Therefore, small and medium enterprises (SMEs) of bakeries have an essential role in creating products that are guaranteed to be halal and safe, following regulations in Indonesia. This research aims to design a Halal Good Manufacturing Practice (HGMP) assessment model for “X” Bakery to improve product quality. HGMP integrates the criteria of Indonesia's Halal Assurance System, called Sistem Jaminan Produk Halal (SJPH), and Good Manufacturing Practices (GMP). The Quality Function Deployment (QFD) method evaluates company performance

APA, Harvard, Vancouver, ISO, and other styles

23

Maitimu, Nil Edwin, and Marcy Lolita Pattiapon. "PENERAPAN GOOD MANUFACTURING PRACTICE PADA UD. XYZ DI KOTA TUAL." ARIKA 15, no. 2 (2021): 115–24. http://dx.doi.org/10.30598/arika.2021.15.2.115.

Full text

Abstract:

Usaha kecil menengah berperan penting dalam mendukung ekonomi Nasional, terutama pada bidang pangan olahan hasil laut. Olahan hasil laut dalam bentuk abon ikan merupakan usaha home industry UD. XYZ. Kondisi usaha abon ikan akan terhambat dengan adanya kejadian-kejadian yang tidak diharapkan atau risiko negatif yang dapat menimbulkan kerugian. Hal ini berkaitan dengan proses sanitasi yang belum maksimal dalam hal sanitasi pekerja, sanitasi alat dan wadah, dan sanitasi bangunan. Penelitian ini bertujuan untuk mengiplementasikan SSOP pada proses produksi Abon Ikan dan menghasilkan produk Abon Ika

APA, Harvard, Vancouver, ISO, and other styles

24

Oeller, Michaela, Sandra Laner-Plamberger, Linda Krisch, Eva Rohde, Dirk Strunk, and Katharina Schallmoser. "Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production." International Journal of Molecular Sciences 22, no. 10 (2021): 5178. http://dx.doi.org/10.3390/ijms22105178.

Full text

Abstract:

Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types. HPL as a raw material permits animal serum-free cell propagation with highly efficient stimulation of cell proliferation, enabling humanized manufacturing of cell therapeutics within a reasonable timeframe. Providers of HPL have to consider dedicated quality issues regarding identity, purity, potency, traceability and safety. Release criteria have to be defined, char

APA, Harvard, Vancouver, ISO, and other styles

25

Griffiths, Elwyn. "Quality standards for biopharmaceuticals: the importance of good manufacturing practice." Generics and Biosimilars Initiative Journal 9, no. 3 (2020): 97–99. http://dx.doi.org/10.5639/gabij.2020.0903.017.

Full text

Abstract:

Regulatory standards for rDNA derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly effective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support in dealing with these highly complex products. This Commentary highlights the need for regulatory convergence and support, notes the critical role of GMP and draws attention to the comprehensive review by Sia Chong Hoc

APA, Harvard, Vancouver, ISO, and other styles

26

Harolds, Jay. "What is Now Current Good Manufacturing Practice for PET Drugs?" Clinical Nuclear Medicine 35, no. 5 (2010): 329. http://dx.doi.org/10.1097/rlu.0b013e3181db9d6d.

Full text

APA, Harvard, Vancouver, ISO, and other styles

27

Lusky, Monika. "Good Manufacturing Practice Production of Adenoviral Vectors for Clinical Trials." Human Gene Therapy 16, no. 3 (2005): 281–91. http://dx.doi.org/10.1089/hum.2005.16.281.

Full text

APA, Harvard, Vancouver, ISO, and other styles

28

Bosse, R., P. Kulmburg, C. von Kalle, et al. "Production of stem-cell transplants according to good manufacturing practice." Annals of Hematology 79, no. 9 (2000): 469–76. http://dx.doi.org/10.1007/s002770000176.

Full text

APA, Harvard, Vancouver, ISO, and other styles

29

Tulina, M. A., and N. V. Pyatigorskaya. "Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products." Bulletin of Experimental Biology and Medicine 164, no. 4 (2018): 579–82. http://dx.doi.org/10.1007/s10517-018-4035-8.

Full text

APA, Harvard, Vancouver, ISO, and other styles

30

Arayne, M. Saeed, Najma Sultana, and M. Kamran Zaman. "Historical incidents leading to the evolution of good manufacturing practice." Accreditation and Quality Assurance 13, no. 8 (2008): 431–32. http://dx.doi.org/10.1007/s00769-008-0363-0.

Full text

APA, Harvard, Vancouver, ISO, and other styles

31

Erliana, Cut Ita, Iskandar Hasanuddin, Yuwaldi Away, and Raja Ariffin Raja Ghazilla. "Good Manufacturing Practice (GMP) in Tofu MSMEs in North Aceh." SINERGI 27, no. 3 (2023): 443. http://dx.doi.org/10.22441/sinergi.2023.3.015.

Full text

Abstract:

This study examined tofu MSMEs in Lhokseumawe City and the North Aceh District. Observations indicate discrepancies between tofu production and the GMP requirements for Good Manufacturing Practices. The amount that the tofu sector has adopted appropriate food production procedures by the Regulation of the Ministry of Sector of the Republic of Indonesia Number 75/M-IND/PER/7/2010 is determined using a GMP approach. This research is anticipated to improve the product safety of the tofu industry and provide recommendations for improvement. In this study, data collection techniques included candid

APA, Harvard, Vancouver, ISO, and other styles

32

Sari, Indriani Purnama, Nil E. Maitimu, and Alfredo Tutuhatunewa. "PENERAPAN GOOD MANUFACTURING PRACTICE PADA PERUSAHAAN AIR MINUM DALAM KEMASAN." i tabaos 3, no. 1 (2023): 9–16. http://dx.doi.org/10.30598/i-tabaos.2023.3.1.9-16.

Full text

Abstract:

Air minum yang sehat merupakan suatu kebutuhan yang tidak dapat ditinggalkan dan sangat penting bagi kehidupan manusia serta seluruh makhluk hidup karena dibutuhkan dalam berbagai macam kebutuhan seperti pertanian dan perindustrian. tujuan dari penelitian ini yaitu Menganalisis penerapan Good Manufacturing Practice di CV. Abadi Tiga Mandiri. Penilaian penerapan GMP terdiri dari identifikasi kondisi nyata pada ruang lingkup produksi AMDK di CV. Abadi Tiga Mandiri berdasarkan ruang lingkup GMP sesuai dengan peraturan Menteri perindustrian republik Indonesia NO. 75/M-IND/PER/7/2010. Jumlah ruang

APA, Harvard, Vancouver, ISO, and other styles

33

E.M., Aghayev, Suleymanov M.Y., Afandiyev R.V., and Marinchenko Y.V. "NECESSİTY OF PREPARATİON OF SPECİFİC REQUİREMENTS ON GOOD MANUFACTURİNG PRACTİCE." Azerbaijan Pharmaceutical and Pharmacoterapy Journal 23, no. 2 (2023): 38–43. http://dx.doi.org/10.58495/iaqh3241.

Full text

Abstract:

The article investigates existing international and regional requirements on various areas of Good Manufacturing Practice for the production of medicinal products, emphasizes the im-portance of preparing national requirements - annexes to the basic requirements of Good Manu-facturing Practice in the mentioned area, and gives relevant proposals on the relevant topic.

APA, Harvard, Vancouver, ISO, and other styles

34

Kartika, Kartika, cecep abdul cholik,, and Sandi Kurnia. "ANALISA PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PRODUK OLAHAN ROTI (STUDI KASUS: SAE ROTI KUNINGAN)." Jurnal Fakultas Teknik 5, no. 2 (2024): 80–88. http://dx.doi.org/10.70476/jft.v5i2.6.

Full text

Abstract:

Good Manufacturing Practice (GMP) is a reference for every food processing industry so that it can pay attention to food safety so that it can produce quality and healthy food for consumption. This research aims to: (1) determine the implementation of the Good Manufacturing Practice (GMP) system at SAE ROTI. (2) Identifying errors and deviations in the implementation of Good Manufacturing Practice (GMP) at SAE ROTI. (3) Providing solutions and recommending improvements to errors in implementing Good Manufacturing Practice (GMP). This research was conducted using qualitative methods. Data colle

APA, Harvard, Vancouver, ISO, and other styles

35

Rost, Johanna, Steve Langhein, Detlef Bartel, Andreas Bonertz, and Vera Mahler. "Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?" Allergo Journal International 31, no. 2 (2021): 36–42. http://dx.doi.org/10.1007/s40629-021-00193-3.

Full text

Abstract:

Abstract Background All currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The extracted proteins have different properties and their structure is differently labile to temperature variations. Despite various pharmaceutical formulations to increase product stability, with few exceptions, allergen products must be refrigerated to ensure that their quality and native protein structure do not change during storage and transport. Maintaining quality is a challenge in complex distribution chains. Methods Regulatory requir

APA, Harvard, Vancouver, ISO, and other styles

36

Pagolu, Sreenivasa Rao. "Standard Maintenance Practice for Feed Pellet Operation." International Journal of Research in Engineering, Science and Management 3, no. 12 (2020): 56–58. http://dx.doi.org/10.47607/ijresm.2020.406.

Full text

Abstract:

Plant Engineering, Maintenance, Repair and over hauling are most important in manufacturing industries. The aim of this paper is to identify and suggest good standard maintenance practice for feed milling operation in an animal feed manufacturing unit. It derives various results based on practical implementation in feed mill operation and data provided are an actual drawn in feed mill in a feed manufacturing industry. The outcome is discussed and studied in compare with standard maintenance practices.

APA, Harvard, Vancouver, ISO, and other styles

37

Tomić, Siniša, Anita Sučić, and Adrijana Martinac. "Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities." Archives of Industrial Hygiene and Toxicology 61, no. 4 (2010): 425–36. http://dx.doi.org/10.2478/10004-1254-61-2010-2035.

Full text

Abstract:

Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, inclu

APA, Harvard, Vancouver, ISO, and other styles

38

Indrawan, Surya, Juni S, and Sirlyana. "PENDAMPINGAN PENERAPAN GOOD MANUFACTURING PRACTICE UNTUK PENINGKATAN KUALITAS DAN KEAMANAN PRODUK." Jurnal Masyarakat Berdikari dan Berkarya (Mardika) 1, no. 1 (2023): 56–62. http://dx.doi.org/10.55377/mardika.v1i1.8190.

Full text

Abstract:

Increasing competition in the industrial world, especially in the food sector. With increasing competition, companies or business actors are facing pressure to continue to provide quality products, where customers demand good quality at an affordable price. For this reason, a strategy or method is needed to answer these challenges, one of which is by implementing Good Manufacturing Practice which aims to carry out good production procedures, implementation procedures, control and supervision of the implementation of the production process. Tempe UKM is one of the industrial players in Dumai Ci

APA, Harvard, Vancouver, ISO, and other styles

39

Huda, Listiani Nurul, and Rifqi Athaullah. "Ergonomic analysis through good manufacturing practice (gmp) training (case: Binjai MSME)." E3S Web of Conferences 332 (2021): 05002. http://dx.doi.org/10.1051/e3sconf/202133205002.

Full text

Abstract:

The work environment is one of the most important factors in production. In this paper, a study was conducted on the work environment in MSMEs to determine the safety and health of the work environment in producing products. Specifically, the study was conducted to see the deviation in the application of GMP in MSME. The subjects were 30 MSMEs involved in the research from Binjai Municipalities. This study uses a qualitative analysis method that aims to evaluate the level of application of 14 aspects of GMP and find out the understanding of MSMEs on aspects of GMP. The analysis results show th

APA, Harvard, Vancouver, ISO, and other styles

40

Edwin, Tivany, Reinny Patrisina, Alexie Herryandie Bronto Adi, Prima Fithri, and Nindy Hidayah. "Pelatihan Good Manufacturing Practice (GMP) pada Usaha Pangan Binaan Universitas Andalas." Jurnal Warta Pengabdian Andalas 27, no. 1 (2020): 1–5. http://dx.doi.org/10.25077/jwa.27.1.1-5.2020.

Full text

Abstract:

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 production control as well. Small and Medium Enterprises (SME) fostered by Andalas University, which is engaged in the field of food manufacturing, wants to find its products better known and with a wide sales distribution. This can be realized if the business owner has the trust of many consumers. One effort that can be done is to implement the G

APA, Harvard, Vancouver, ISO, and other styles

41

Unger, C., H. Skottman, P. Blomberg, M. Sirac Dilber, and O. Hovatta. "Good manufacturing practice and clinical-grade human embryonic stem cell lines." Human Molecular Genetics 17, R1 (2008): R48—R53. http://dx.doi.org/10.1093/hmg/ddn079.

Full text

APA, Harvard, Vancouver, ISO, and other styles

42

Kuswardhani, Nita, Nidya Shara Mahardika, and Adine Rara Salsabila. "ANALISIS PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PADA PROSES PRODUKSI ROTI GEMBONG." Jurnal Penelitian Sains dan Teknologi Indonesia 3, no. 2 (2024): 357–68. https://doi.org/10.19184/jpsti.v3i2.1567.

Full text

Abstract:

Perkembangan industri di Indonesia terus meningkat seiring dengan teknologi dan sistem produksi yang menunjang industri saat ini. Roti Gembong Hamasah merupakan salah satu perusahaan perseorangan yang bergerak di bidang pangan yaitu Roti Gembong. Evaluasi GMP mencakup 18 aspek seperti lokasi, bangunan, sanitasi, mesin, bahan, pengendalian proses, produk akhir, laboratorium, karyawan, pengemasan, label, penyimpanan, pemeliharaan, transportasi, dokumentasi, pelatihan, penarikan produk, dan penerapan pedoman. Analisis kesenjangan dengan metode gap analysis menunjukkan skor penerapan GMP sebesar 7

APA, Harvard, Vancouver, ISO, and other styles

43

Moog, Rainer, and Norbert Müller. "Quality assurance system in haemapheresis according to current good manufacturing practice." Transfusion Science 20, no. 1 (1999): 79–81. http://dx.doi.org/10.1016/s0955-3886(98)00096-4.

Full text

APA, Harvard, Vancouver, ISO, and other styles

44

Angelucci, Louis A. "Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities." Drug Information Journal 33, no. 3 (1999): 739–46. http://dx.doi.org/10.1177/009286159903300312.

Full text

APA, Harvard, Vancouver, ISO, and other styles

45

Bhattacharya, Joymalya. "Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry." IOSR Journal of Pharmacy and Biological Sciences 9, no. 5 (2014): 24–37. http://dx.doi.org/10.9790/3008-09562437.

Full text

APA, Harvard, Vancouver, ISO, and other styles

46

Wöhle, W. "Good Manufacturing Practice bei Herstellung und Prüfung von In-vitro-Diagnostika." LaboratoriumsMedizin 10, no. 7-8 (1986): 235–36. http://dx.doi.org/10.1515/labm.1986.10.7-8.235.

Full text

APA, Harvard, Vancouver, ISO, and other styles

47

Cunningham, Sarah, and Holger Hackstein. "Recent Advances in Good Manufacturing Practice-Grade Generation of Dendritic Cells." Transfusion Medicine and Hemotherapy 47, no. 6 (2020): 454–63. http://dx.doi.org/10.1159/000512451.

Full text

Abstract:

Dendritic cells (DCs) are pivotal regulators of immune responses, specialized in antigen presentation and bridging the gap between the innate and adaptive immune system. Due to these key features, DCs have become a pillar of the continuously growing field of cellular therapies. Here we review recent advances in good manufacturing practice strategies and their individual specificities in relation to DC production for clinical applications. These take into account both small-scale experimental approaches as well as automated systems for patient care.

APA, Harvard, Vancouver, ISO, and other styles

48

Ways, Judy P., M. Sue Preston, Donald Baker, Jean Huxsoll, and Jason Bablak. "Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation." Biotechnology and Applied Biochemistry 30, no. 3 (1999): 257–65. http://dx.doi.org/10.1111/j.1470-8744.1999.tb00779.x.

Full text

Abstract:

The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma‐fractionation industry has experienced increased compliance‐related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the imp

APA, Harvard, Vancouver, ISO, and other styles

49

Budiman, Erwanda, Muhammad Ilyas, Levina Khoe, Nuri Adi, and Agus Sugiharto. "P-164 KNOWLEDGE, ATTITUDE, AND PRACTICE ON OCCUPATIONAL HEALTH PREVENTION AMONG MANUFACTURING WORKERS IN JAVA ISLAND, INDONESIA." Occupational Medicine 74, Supplement_1 (2024): 0. http://dx.doi.org/10.1093/occmed/kqae023.0681.

Full text

Abstract:

Abstract Introduction There were increasing number of occupational accident and work-related disease cases among manufacturing workers in Indonesia, especially in Java Island. Therefore, strategies to implement occupational health prevention are necessary to reduce the number of these cases. This study aims to determine the knowledge, attitude, and practice of manufacturing industry workers in Java Island on occupational health prevention and its influencing factors. Methods Cross-sectional design was utilized among manufacturing workers. Data was obtained from the Indonesian Occupational Medi

APA, Harvard, Vancouver, ISO, and other styles

50

Aziza, Farida. "Comparison Review of Two Regulatory Agencies Regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in Relation to Good Manufacturing Practice (GMP) Guideline." Majalah Farmaseutik 17, no. 2 (2021): 243. http://dx.doi.org/10.22146/farmaseutik.v17i2.60237.

Full text

Abstract:

There are some regulatory bodies in the world that impacting the pharmaceutical industry to operate and perform Good Manufacturing Practice (GMP) principles. These regulatory bodies exist to ensure that the pharmaceutical product and other human supporting products have a high standard of quality, safety, and efficacy from product registration to product distribution to the patient. This article reviews some aspects which is regulated by two of regulatory entities including Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) in relation with Good Manufacturing Practice (

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!