Media Fill for Validation of a Good Manufacturing Practice-Compliant Cell Production Process

Author(s):  
Marta Serra ◽  
Livia Roseti ◽  
Alessandra Bassi

Cytotherapy ◽  
2014 ◽  
Vol 16 (6) ◽  
pp. 750-763 ◽  
Author(s):  
Sara Castiglia ◽  
Katia Mareschi ◽  
Luciana Labanca ◽  
Graziella Lucania ◽  
Marco Leone ◽  
...  


2021 ◽  
Vol 5 (2) ◽  
pp. 94
Author(s):  
Rezki Amelia Aminuddin A.P., Hari Purnomo

Background: In the production process, small accidents often occur between fellow workers in the production area, such as workers colliding with each other during the transfer process from one process to the next which causes the product to spill and workers fall, causing injury. PT. XYZ is a company engaged in the seafood industry, especially canning crabs. The company's production process applies a Good Manufacturing Practice (GMP) system with 12 work areas and 80% of the process is still done manually. Purpose: The purpose of this study is to identify risks and control the implementation of the HACCP system in the crab canning industry using the HAZOP method. Method: This type of research is a descriptive study, using the HAZOP (Hazard and Operability) method. The research was carried out at 12 nodes, namely receiving, checking aroma, sorting, mixing and filling, metal detecting, weighing, seaming, pasteurization, chilling, packing, and sanitation. Result: The results showed 4 risk ratings, namely low, medium, high, and extreme risk based on 8 sources of potential hazards. The biggest risk that is extreme is in node seaming. Conclusion: Based on processing data, 8 sources of potential hazards that can occur in the pasteurized crab meat production room. The recommendations given are to implement elimination, reduction, engineering control, administrative control, Personal Protective Equipment, work attitude improvement, and OHS training.



2013 ◽  
Vol 66 (3-4) ◽  
pp. 170-176
Author(s):  
Sofija Djordjevic ◽  
Aleksandra Dickov ◽  
Sava Pavkov ◽  
Vanja Tadic ◽  
Ivana Arsic ◽  
...  

Introduction. Rational phytotherapy is a modern concept of using plant-originated drugs which has emerged from the need to improve phytotherapy in order to make the use of herbal remedies more efficient and safer. The aim of this study was to give the health-care workers more information on the manufacturing process of high quality phytopreparation following principles of Good Manufacturing Practice and Good Laboratory Practice on the example of herbal sedative, Odoval S? capsules. Material and Methods. This study was designed to reflect the production process of a high-quality and safe herbal remedy, starting from defining the formulation and the production procedure to the quality control of raw materials, characterization of the final product, and testing stability of active ingredients in the capsules. Results. Formulation of the phytopreparation, validation of the production process, quality control and stability testing, all together have resulted in the production of capsules with defined valeric acid content (1 mg valeric acid per capsule). Discussion. The preparation is recommended to relieve the symptoms caused by chronic stress (anxiety, irritability, fatigue, lack of concentration, heart palpitations) and for mild insomnia. Conclusion. This paper presents the complete cycle of the production of a phytopreparation on the example of a new herbal sedative - Odoval S? capsules.



2003 ◽  
Vol 6 (4) ◽  
pp. 265-273 ◽  
Author(s):  
Yoshiaki Inukai ◽  
Masami Miwa ◽  
Yasuo Nagato ◽  
Hidemi Kitano ◽  
Akira Yamauchi




1968 ◽  
Vol 122 (3) ◽  
pp. 230-235 ◽  
Author(s):  
A. J. Erslev
Keyword(s):  
Red Cell ◽  




2019 ◽  
Vol 28 (9) ◽  
pp. 50-53
Author(s):  
N.N. Martynov ◽  
◽  
G.A. Sidorenko ◽  
G.B. Zinyukhin ◽  
E.Sh. Maneeva ◽  
...  
Keyword(s):  


Sign in / Sign up

Export Citation Format

Share Document