Article Per Year (5 Year)
p-Index From 2021 - 2026
3.374
P-Index
This Author published in this journals
All Journal CAKRA KIMIA (Indonesian E-Journal of Applied Chemistry) INDONESIAN JOURNAL OF LEGAL AND FORENSIC SCIENCES Journal Pharmaceutical Science and Application (JPSA) Buletin Udayana Mengabdi Jurnal Farmasi Udayana Indonesian Journal of Pharmaceutical Science and Technology Syntax Literate: Jurnal Ilmiah Indonesia Jurnal Bali Membangun Bali Humantech : Jurnal Ilmiah Multidisiplin Indonesia Sains Medisina Prosiding Workshop dan Seminar Nasional Farmasi (WSNF) Svāsthya: Trends in General Medicine and Public Health
Ni Kadek Warditiani
Program Studi Farmasi Universitas Udayana
Religion Agriculture, Biological Sciences & Forestry Arts Humanities Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Civil Engineering, Building, Construction & Architecture Computer Science & IT Decision Sciences, Operations Research & Management Dentistry Economics, Econometrics & Finance Education Electrical & Electronics Engineering Environmental Science Health Professions Immunology & microbiology Languange, Linguistic, Communication & Media Law, Crime, Criminology & Criminal Justice Materials Science & Nanotechnology Medicine & Pharmacology Public Health Social Sciences Transportation Other

Published : 58 Documents Claim Missing Document
Claim Missing Document
Check
Articles

Found 1 Documents
Search
Journal : INDONESIAN JOURNAL OF LEGAL AND FORENSIC SCIENCES

 1 
Evaluasi SPO Pengujian Produk Jadi Pre-Marketing terhadap Mutu Sediaan COL (Cairan Obat Luar) Tradisional di Salah Satu Industri X Komang Tri Farmani; Ni Kadek Warditiani
Indonesian Journal of Legal and Forensic Sciences (IJLFS) Vol 12 No 2 (2022): Indonesian Journal of Legal and Forensic Sciences
Publisher : Penerbit, sejak 2012 : Asosiasi Ilmu Forensik Indonesia dan UPT Lab. Forensik Sain dan Kriminilogi - Universitas Udayana

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24843/IJLFS.2022.v12.i02.p01

Abstract

Introduction: The traditional medicine industry (TMI) is an industry that can produce all types of traditional medicinal preparations including EML (external medicine liquid). In the process of making traditional medicine (TM), TMI is obliged to follow the rules of GMPTM (good manufacturing practices traditional medicines) which aims to ensure the quality of the preparations produced. In the process, an SOP (standard operating procedure) is needed which contains the steps that must be taken to realize the goals and product quality (specifications) that have been determined. Pre-marketing finished product testing is part of the production process, so it also requires an SOP. One of the IOT X that has made CML has been established long time, of course it already has a Finished Products Pre-Marketing EML Preparations Testing SOP. Objective: to evaluate the SOP of Pre-Marketing Finished Product Testing on the quality of COL preparations, based on quality standards finished products which are regulated in BPOM Regulation No. 32 of 2019 concerning the Safety and Quality Requirements for Traditional Medicine and 1996 SNI (Indonesian National Standard), and GMPTM 2021. Methods: literature study and observational description with a qualitative approach in the form of interviews Results: SOP is in accordance with existing EML quality standards, its implementation has also been implemented well (during the production of COL X products never happened not eligible), and there has never been a recall of EML products during the production period. Conclusion: The SOP for testing finished products in the pre-marketing phase has been implemented properly in accordance with applicable regulations.
Co-Authors Ade Winanda Pangestu Adi P.S, I.K Agus Adi Purnama Putra Ananda Putri, Ida Ayu Ngurah Trisna Noviani Andika, Dewa Made Dwi Ariswari, Ni Kadek Putri Arkhania, Ni Putu Ayu Dhea Armita, Pande Made Nova Artini, P. E. U. D Asih, Diah Jenari Astarina, N. W. G. Astuti N.M.W. Astuti, K. W. Astuti, K.W. Astuti, Ni Made Widi Bayu J.K, I.M Budiman, I.N.A C. Juwianti Candrayani, Komang Tri Chantika P, N.K Cokorda Istri Sri Arisanti Dewa Ayu Swastini Dewa, Julio Angga Purnama Dewi K. A. S. Dewi P.E.M.U Dewi S.M. Dewi Wulandari Dewi, A.A.A.P.K. Dewi, I Gst A A Gangga Samala Dewi, I Gusti Ayu Widha Paramistya Dewi, I.D.A.D.Y. Dewi, N.P Apsari Dewi, N.P.A.K. Dewi, Ni Kadek Santi Maha Dewi, Ni Pande Kadek Sinta Dharmapradnyawati N.N.P. Diah K, Shinta G.D. Pranawa Gitarini N. M. Hapsari, Meivanti Diva I Gede Sandi Wiarsana I Ketut Adnyana I Made Agus Gelgel Wirasuta I N.K. Widjaja I Nyoman Arsana I Nyoman Arsana, I Nyoman I Putu Sudiartawan I Wayan Martadi Santika I. Damanik, I. N. T. Wisesa I.A.T Dewi I.B.D Esa I.M.K.A Suyadnya I.M.S. Sapanca Ida Bagus Putra Suta Ida Bagus Wiryanatha IG.Y Prayadnya IK.A.Y. Murti Indrani, A.A.I. S. Indriani N. P. W. Indyayani I.G.A Jayanti, N.K.P Aprilia Juniari N.P.M. K. Megayanti Kadek Dian Widyapurwanti Kinanti, Novi Sekar Komang Tri Farmani Kopong, Maria Vianey Uma Luh Putu Febryana Larasanty M. A. P. P. Rashid M. Primantara Made Galu Putra Ardiana Maha Dewi, Ni Kadek Santi Maruli Davidson Sitompul Milawati Milawati Mutiarani Dasha Hanggaresty Mutiarani Dasha Hanggaresty Mutmainah, Susanti N.K.A. Suksmawati N.K.I.P Dewi N.L.P.A Pratiwi N.M. Febrianti N.M. Suryaningsih N.P. Widiastuti N.P.R.A Putri N.P.R.D. Putri N.W.W Citradewi Nasya Nathania Chandra Natalia Kote, Jessica Christy Ni Luh Gede Sudaryati Ni Luh Putu Putri Dewi Ni Made Pitri Susanti Ni Made Widi Astuti Ni Made Widi Astuti Ni Made Widiastuti Ni Putu Eka Leliqia Ni Putu Linda Laksmiani Ni Putu Wahyudewi Primananda Noviyanti N. W. R Noviyanti, Ni Putu Rika Nugrahaeni, Luh Gede Ratih Dewi Tri Nugroho A.E. Oka M. P.A. Pramana, P.A. Savitri, P.P.K. Vedawati P.R. Satriari Padmanaba I.G.P. Padmasari, P.D. Pande Made Nova Armita Pande Made Nova Armita Sari Pande Made Nova Armita Sari, Pande Made Nova Permatasari, Ni Made Ayu Dinda Pinangkaan, C. Pramono S. Prascitasari, Ayu Prasetya, I Wayan Sindhu Wahyu Putri, Lucienne Agatha Larasati Nugraha Putri, W. S. Putu Dinda Pradnya Putri Permatasari Putu Lakustini Cahyaningrum Putu Oka Samirana R. Wirayanti Rahayu, N.P Savitri Rajeswari, Ni Kadek Ida Ratih, Ayu Putu Pramana Maha Rismayanti, A. A. M. I. Sanjaya, Sadina Vania Tsany Dyah Sanjiwani, P. Sarasmitha M.A Sarayawati, Kadek Ayu Mas Sari , Putri Ayu Puspita Sari, N. A. P. P. Septiarini, Putu Ayudia Setyawan E.I Setyawan E.I. Siahaan, T. F. Silalahi, Lydia Devy Sudiartawan, I Putu Sugiantara, I.W Eka Suhendi, Jessica Rianty Sunariyani, P. E. A. Suryani, N.P Febri Susanti, N.M.P Suta, Ida Bagus Putra Swasti, I.A.S. Talitha Amanda Hartono wahyuni, LP eka Wahyuni, N.N.S Wahyuni, Ni Luh Komang Widhiastuti, K.A.P. Widjaja I N.K. Widjaja I. N. K Widjaja I.N.K Widjaja I.N.K. Widjaja, I. N. K. Widjaja, I.N.K Wijayanti, N.L.P.D Windarini, L.G.E. Wiputri N.M.C.A.