Implementation Of GMP Research Articles

ANALISIS GOOD MANUFACTURING PRACTICES (GMP) DI PANTI SOSIAL LANJUT USIA MANDALIKA

Diseases transmitted through food or WHO calls them food-borne diseases (Food Borne Diseases) are infectious diseases or poisoning caused by microbes or agents that enter the body through the food consumed. This research aims to find out how GMP is implemented in food management at the Mandalika Social Home for the Elderly and recommend follow-up actions. This qualitative research uses a descriptive analysis approach. This research uses informants, namely nutritionists, as providers of information regarding the situation and conditions of the research setting with instruments as interview tools. Data analysis in this research uses the GAP Analysis method, namely to analyze the gaps that occur in the implementation of GMP at the Mandalika Elderly Social Home followed by recommending follow-up actions on aspects that have a low average score. This research shows that the implementation of GMP in the Mandalika Social Home for the Elderly is 79.59% with the highest implementation being in the aspects of materials, final products and packaging, namely 100%, while the lowest implementation is in the laboratory aspect, labels and product descriptions, training and record keeping with percentages by 40%.

Evaluasi Penerapan Good Manufacturing Practices Produk Minuman Botanikal Jahe Siap Minum di PT XYZ

<p><strong>In improving the quality of food products as an effort to build a competitive UMKM economic structure, it’s necessary to implement Good Manufacturing Practices to produce the quality and suitable for consumption products. GMP is used as a general reference for food industries which is designed to prevent problems related to the quality and safety of food products. The aim of this research was to evaluated the implementation of GMP for Ginger Botanical Drink product which includes 18 aspects of assessment based on the Minister of Industry's regulation regarding GMP. This research was conducted in a qualitative descriptive. The 11 respondents were employees in the management and production departments with the instruments were field observation and interview on each aspect of GMP parameters. The result of this research showed that GMP implementation at PT XYZ is classified as Level 3 with some non-conformities, there were 2 points in the mayor category from the building aspect, 2 points in the mayor category from the sanitation facilities aspect, 1 point in the mayor category and 1 point in the critical category from the machine and equipment aspect, 1 point in the mayor category from the final product aspect, 1 point in the critical category from the employee aspect, and 1 point in the mayor category from the storage aspect. This proves that the implementation of GMP at PT XYZ is still not good enough, therefore, several improvement recommendations need to be given.</strong></p><p><strong><em>Keywords </em></strong>- <em>Evaluation, GMP, Improvement Recommendations, UMKM</em><em>.</em></p>

Evaluasi Implementasi Cara Produksi Pangan Yang Baik (CPPB) Untuk Industri Rumah Tangga Produksi Bolen

Efforts to obtain safe and quality food include good food processing and management of a clean production environment. Implementation of good production by applying the CPPB-IRT food safety assurance system as a processing guideline. The basis of analysis uses 14 aspects, namely location and production environment, buildings and facilities, production equipment, facilities for providing water, sanitation facilities and practices, employee health and hygiene, maintenance and hygiene and cleanliness programs, storage, process control, food labeling, supervision from the person in charge, product recall, recording and documentation, and employee training. The research data collection used observation, interviews, checksheet filling and literature study. The results of the analysis based on BPOM regulation No. HK.03.1.23.04.12.2206 stated that CPPB-IRT in bolen production achieved a percentage conformity of 86.6% and a non-conformity of 13.4%. The assessment of non-conformity is found in the criteria in several aspects following the criteria from the aspects of buildings and facilities, employee health and hygiene, maintenance and cleaning and sanitation programs, storage, supervision by the person in charge, product recall, recording and documentation. The results of the analysis of BPOM regulation No. HK.03.1.23.04.12.2207 state that there are 4 out of 14 aspects of CPPB-IRT bias, namely in the aspects of buildings and facilities, employee health and hygiene, supervision by the person in charge, recording and documentation. Deviations in the implementation of GMP can be a reference for policy makers in creating regulations or strategies so that SMEs are able to implement GMP thoroughly

GMP implementation of a hybrid continuous manufacturing process for a recombinant non-mAb protein-A case study.

Advances in manufacturing technology coupled with the increased potency of new biotherapeutic modalities have created an external environment where continuous manufacturing (CM) can address a growing need. Amgen has successfully implemented a hybrid CM process for a commercial lifecycle program. In this process, the bioreactor, harvest, capture column, and viral inactivation/depth filtration unit operations were integrated together in an automated, continuous module, while the remaining downstream unit operations took place in stand-alone batch mode. CM operations are particularly suited for so-called "high mix, low volume" manufacturing plants, where a variety of molecules are manufactured in relatively low volumes. The selected molecule fit this mold and was manufactured in a low-capital micro-footprint suite attached to an existing therapeutic production facility. Use of a hybrid process within an already operating facility required less capital and minimized complexity. To enable this hybrid CM process, an established fed-batch process was converted to a perfusion process with continuous harvest. Development efforts included both process changes and the generation of a novel cell line adapted to long-term perfusion. Chromatography resins were updated, and purification processes adapted to handle variable inputs due to the fluctuations in harvest titer from the lengthy production process. A novel automated single-use (SU) viral inactivation (VI) skid was introduced, which entailed the development of a robust pH verification and alarm system, along with procedures for product isolation to allow discard of specific cycles. The CM process demonstrated consistent performance, meaning it met predefined performance criteria (including product quality attributes, or PQAs) when operated within established process parameters and manufactured according to applicable procedures. Using a 75% reduction in scale, it resulted in a five-fold reduction in process media and buffer usage, a fifteen-fold increase in mass per thaw, and an overall process productivity increase of 45-fold (as measured by grams drug substance per liter per day.) The hybrid CM process also enabled increased material demand to be met with no change in cost of goods manufactured or plant capacity, due to the repurposing of existing facility space and the flexible duration of the hybrid CM harvest. Overall, the success of the hybrid CM platform represents an exciting opportunity to reduce costs and increase process efficiency in industry.

Penerapan Sistem Good Manufacturing Practices (GMP) Pada Proses Pembekuan Ikan Layur DI CV. Sinar Harapan Berau

The freezing industry requires a basic eligibility program to provide guarantees for a food safety system. The application of GMP or Good Manufacturing Practices in the food industry is a requirement to produce products that are safe for consumption. The aim of the study was to examine the application of GMP in freezing layur fish at CV. Sinar Harapan Berau and identify non-compliance factors in the implementation of GMP. The results showed that the application of GMP in CV. Sinar Harapan Berau has largely complied with the CPPOB guideline requirements. Based on the analysis of non-conformity, there are 14 aspects that are suitable and 4 aspects that are not suitable with the percentages of 77.8% and 22.2%, respectively. Several factors cause non-compliance with GMP, namely puddles of water on the road leading to the production site, the road has not been cemented, and without laying stones. There are no washing facilities in the toilet area, there is still rust on the tables and pans in the production area. CV. Sinar Harapan also does not yet have laboratory facilities for quality control and safety of raw materials, but only inspects organoleptically.

State youth policy: search for an integrative model formation

A period has come in Russia when institutional transformations in matters of state youth policy (GMP) are objectively necessary. They presuppose the formation and development of a coherent system of youth affairs bodies, ensuring coordination of efforts of state bodies, local self-government bodies and civil society institutions to implement GMP. The problem is that Russia has been searching for an integrative management model in this area for more than 30 years, discussions continue about the interdepartmental and sectoral nature of GMP, its essence and typology. This article focuses on the issue of a management body in the field of GMP, designed to ensure the integration of the activities of all its social actors. According to the author, it should be created in the rank of a federal ministry. Dialectical and systematic approaches, historical, logical, formal-legal, comparative and structural-functional research methods are used for substantiation. A brief history of the creation and functioning of federal and regional bodies for youth affairs is given, attention is drawn to their current composition and development trends. Conclusions are drawn about the actual approach to the independence of the status of the executive authority responsible for the development and implementation of GMP, its regulatory and legal regulation in the Russian Federation, and measures are proposed to improve integration processes in the management of the sphere under consideration.

Kajian Penerapan Cara Pembuatan Obat Tradisional yang Baik pada Industri Ekstrak Bahan Alam di Indonesia

Good Manufacturing Practices for Traditional Medicine (GMP for TM) must be applied by Traditional Medicine Businesses in Indonesia, namely Traditional Medicine Small Businesses (TMSB), Traditional Medicine Micro Businesses (TMMB), Traditional Medicine Industry (TMI) and Active Traditional Medicine Ingredients Industries (ATMII), to ensure the quality of the products produced. At the end of 2021, the Indonesian FDA established the most recent GMP for TM standards, which follow the PIC / PE 009-015 standard that must be applied by TMI and ATMII, with an appendix related to GMP for Active Ingredients Traditional Medicine (ATMI) for ATMII. This study aims to determine the GMP profile for TM implementation, specifically in 17 ATMII in Indonesia, and to provide recommendations to the Indonesian FDA in supervising and assisting ATMII. The method was carried out by creating a list of questions from 17 aspects of GMP for Active Ingredients TM, including aspects of product development and technology transfer, to be filled out independently by 17 IEBA, followed by verification and assessment of compliance with the implementation of GMP for TM with the conclusion of the assessment results of the categories are very good, good, sufficient, and poor. According to the findings of the current GMP for TM application, 6 ATMII (35.3%) received a very good assessment result, 6 ATMII (35.3%) received a good assessment result, 3 ATMII (17.6%) received sufficient assessment results, and 2 ATMII (11.8%) received poor assessment results. The current GMP for TM implementation by ATMII that requires attention are Contract Manufacturers (Including Laboratories), product development and technology transfer, personnel, quality control, and validation, whose average level of fulfilment is still less than 80%. These aspects are critical because they significantly influence the consistency of the quality.

Pharma Software - A Complete Overview

With the recent advancements in Pharmaceutical Industry, there comes an increased complexity in data and products. In a Pharmaceutical Industry, various aspects are considered simultaneously. So, nowadays various advanced softwares are used to handle these parameters. A Software is a set of programs that tells a computer what tasks it should perform. It consists of a series of code written by a programming language, which is then interpreted by a computer. This process is known as compilation. Thus, it makes our work easier by maintaining all the records and performing necessary calculation and much more. In a pharmaceutical industry variety of software are used as the tasks that needs to be performed are also of various types. For example, Record keeping of a Batch of Tablet in a manufacturing section, Quality Control Test Results, Regulatory Management, Marketing And Sales Data Handling, Clinical Trial Data Management, etc. Sometimes, a single software is used and sometimes a combination of two or more are used. There are roughly 19 types of software used in the whole Pharmaceutical Industry, and among them various companies have their wide range of products. Currently, after the implementation of GMP, GLP and GCP, the use of the software has marginally increased. Keywords: Pharmaceutical, Software, Industry, Recent software, Pharma- Industry

SISTEM JAMINAN KEAMANAN PANGAN BERDASARKAN FSSC 22000 versi 5.1 / ISO TS 22002-4 PADA PROSES PRINTING DI INDUSTRI FLEXIBLE PACKAGING

A HACCP analysis of the printing process at one of the process steps in the Flexible packaging industry has been carried out as a hazard analysis step to determine the hazards that need to be controlled. The initial steps for making a flow chart have been carried out, which includes a flow chart of the printing process, which is the object of research. As per the ISO 22000 clauses that all food safety hazards that may occur related to the type of product, type of process, and existing process facilities are identified and recorded, a flowchart for the printing process is made in detail, including input, process, and output. This is to avoid product types, process types, and process facilities that can be overlooked during the hazard analysis process. In the HACCP analysis of the printing process, each food safety hazard has been identified and the acceptable level of the hazard has been determined. The results of the HACCP analysis on the printing process in this study have identified several process stages, from the input process to the output process. All of these stages have been analyzed for all hazards or sources of hazards, level of acceptance, hazard assessment, linkages with regulations or legislation, and determination of actions to prevent, reduce, or eliminate hazards. If the hazard assessment results in a "high" risk value and/or is related to regulations or legislation, then further analysis is carried out to determine whether a CCP is required or not. By carrying out a HACCP analysis of the printing process for the manufacture of flexible packaging, it is possible to determine the OPRP and CCP for the process, so that food safety guarantees in this process can be controlled and realized. The results of the validation process by monitoring the results of hazard measurements on residual solvent as a hazard from CCPs that have been determined in the printing process have shown that the process is under control and capable. The main findings in this study cannot be separated from the strong pillar support of GMP implementation, which is a rule or requirement from ISO/TS 22002-4 and FSSC requirements for the food packaging industry.

Level of Implementation of GMP and SSOP in SMEs Wet Noodle Production Process with Gap Analysis Tools

Level of Implementation of GMP and SSOP in SMEs Wet Noodle Production Process with Gap Analysis Tools

Analisis Penerapan Good Manufacturing Practice (GMP) di CV. Buana Citra Sentosa, Yogyakarta

GMP application is used to support the industry to be responsible for the products produced. In addition, by implementing GMP, the competitiveness of the industry will increase. The application analysis of the GMP in CV. Buana Citra Sentosa aims to provide solutions caused by GMP deviations in the industry. The method used in analyzing the GMP application is the scoring method with the AHP (Analytical Hierarchy Process) method approach. The results of the evaluation can be used to determine the compatibility of GMP implementation. Based on the GMP feasibility level assessment, CV. Buana Citra Sentosa was at a satisfactory level and was declared eligible.Total GMP assessment score in CV. Buana Citra Sentosa is 493 which means it is close to the requirements of the Good Processed Food Production Method.

Accelerating downstream analytical testing for gene therapy

Watch the video or read the poster to learn: The benefits of rapid, reliable in-process testing for AAV downstream process development How utilizing Slope Spectroscopy can remove or automate multiple process stepsGene therapy case studies demonstrating use of the SoloVPE System to make real-time decisions for viral vector applicationsHarald Ehlen has been with Repligen for almost 2 years, supporting Biopharma analytical development, GMP implementation, and QC validation of Slope Spectroscopy® methods and instruments for rapid bioprocess analytics. Prior to working with Repligen, he gathered 6 years of experience as Senior Pharma Analytics Application Specialist and Bioproduction Application Specialist supporting Biopharma QC and Analytical Development. He graduated in Biology at the University of Cologne where he also retrieved a PhD in Physiological Chemistry and then spent several years as scientist studying the physiology, pathogenesis, and development of the skeletal system before moving to the biotech industry. When not in the lab, you can find Harald enjoying playing guitar or spending time with his wife and two children.

The prevalence of foodborne parasites in raw vegetables in Iran: a comprehensive systematic review and meta-analysis.

The online version contains supplementary material available at 10.1007/s40201-021-00714-w.

ORGANISATIONAL AND INDIVIDUAL FACTORS ON THE IMPLEMENTATION OF GREEN MANUFACTURING PRACTICES IN MALAYSIA

International Reports announced that Malaysia's commitment in reducing low carbon emission to overcome environmental problems is inconsistent, where the commitment is considered to be slow or uneven, although various initiatives such as tax exemptions and financial funds are provided by the Malaysian government to manufacturing companies. Empirical studies suggested that the weakness of the company's leadership or the lack of highly skilled workforce in GMP have become one of the key problems. Therefore, this study intends to examine organizational and individual factors in influencing GMP's implementation, as well as evaluating whether servant leadership plays a significant role in GMP implementation as a mediator. The initial results revealed that factory managers indicated organizational factors as the most influential factor in motivating manufacturing companies to implement effective GMP in Malaysia, specifically proactive communication. Meanwhile, individual factors is indicated as the second influential factor in motivating manufacturers implement GMP in Malaysia. In addition, servant leadership mediated the relationship between both factors in implementing effective GMP, providing new knowledge for researchers and other industrial players in Malaysia. Nevertheless, further analysis is required in order to provide more empirical evidences on this research.

MASTER CLASS APPLICATION OF A COMPLEX OF APPROPRIATE PHARMACEUTICAL PRACTICES IN THE PROFESSIONAL TRAINING OF FUTURE MASTERS OF PHARMACY

The article reveals the theoretical justification and methodological principles of designing a master class on the application of a set of good pharmaceutical practices in the training of future masters of pharmacy in higher education. It is determined that the practical implementation of the theoretically grounded principles of promoting the development of higher pharmaceutical education and the formation of professional competence of future masters of pharmacy in Ukraine based on the results of systematic analysis in the context of European integration of educational processes. the process of training future masters of pharmacy at universities in Central and Eastern Europe and in Ukraine. The design of integrated implementation in the educational process of professional training of future masters in the specialty 226 - Pharmacy, the use of interactive method and case-studi technology to assess the quality of the master class.
 To provide pharmaceutical care based on evidence-based medicine and pharmacy on the basis of GPP implementation, it is necessary to comprehensively apply the methods of pharmacoeconomic analysis. An algorithm for the phased implementation of pharmacoeconomic analysis based on the integrated application of methods has been developed.
 It is established that the Guidelines on Good Practices in Pharmacy in Regulated Markets are used at all stages of the circulation of medicines. At the stage of drug development, their safety and dose-dependence of efficacy on the basis of integrated implementation of GMP and GLP are studied.
 At the stage of substantiation of the design of research in the process of clinical trials of therapeutic efficacy and safety, the regulatory document is a guideline with GLP.
 To assess the quality of the proposed solution of situational problems using the interactive method and case-study technology, the software package "Case of professional readiness of masters of pharmacy to implement professional competencies of pharmacoeconomic justification of rational pharmacotherapy and support of pharmaceutical care."

Ergonomic analysis through good manufacturing practice (gmp) training (case: Binjai MSME)

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 that the types of products with the most considerable deviations from the GMP aspect are Bakery Products and Ready-to-Eat Snacks MSMEs. However, overall, the most urgent aspects to improve are Aspect Process control and Production Location and Environment. The deviation results can reach 100%, indicating that GMP implementation is lacking or does not apply GMP.

Diagnosis of hygienic-sanitary conditions in restaurants located in the municipality of Cametá-Pará

The law by the ANVISA requires GMP in food. This study aimed to apply the checklist to assess hygienic-sanitary conditions and provide lectures and support materials in restaurants located in the municipality of Cametá-PA. It is a descriptive survey in eighteen restaurants using a quality measurement instrument called a checklist. In addition to the proposal of forms to verify the impact of corrective actions. This verification instrument is part of the requirements required by RDC No. 216/2004 of ANVISA, based on the RDC No. 275, of October 2002 of ANVISA. It was found through the results obtained that all the popular restaurants studied did not satisfactorily comply with the current Brazilian legislation and were classified in groups II and III, that is, they reached a maximum of 75% compliance. Thus, through the diagnosis obtained through the application of the checklist, it is noticed that the restaurant owners have little knowledge about the implementation of GMP; consequently, in none of the evaluated restaurants, these practices are adopted. Thus, they do not comply with the country's current legislation. Corrective actions and delivery of support materials helped the owners. However, it is necessary to support the Health Surveillance, in addition to charging consumers for improvements to these establishments, since adequate sanitary hygienic conditions are an ongoing process.

The role of innovation in the development of melinjo chips agro-industry in Aceh

Melinjo chips are commonly eaten by Indonesian people as a condiment when having the main course. Aceh is one of the well-known areas for producing melinjo chips which yield up to 60 tonnes melinjo seeds in 2017. This paper aims at identifying the current condition of the production of melinjo chips enterprises, quality of products, and production problems faced by melinjo chips SME in Aceh. This paper also proposes recommendations for technology adoption by SMEs. This research took place in Pidie Regency, Aceh Province. The participants were selected using purposive sampling. Production process steps were selecting raw materials, frying, peeling, pounding, and drying. Problems faced by the SMEs are the inconsistency of finished product quality, non-standardized production process, low level of GMP implementation and lack of adoption of new technology. The recommendations are to change the production equipment, apply GMP guidelines for food production, use SNI for grading, and form a cluster.

FAKTOR PENGHAMBAT PENERAPAN GOOD MANUFACTURING PRACTICES PADA PROSES PENGENDALIAN KUALITAS BANDREK DI CV. X

Along with the increasing production of food and beverage industry in Indonesia, people today insist for hygienic food product. CV. X is a n Industry that produces instant drinks. However, CV. X has not implemented Good Manufacturing Practices on the quality control of its products. There are employees who have not complied with the regulations while working and the machine has been damage several times, so it inhibit the production process. As a result, there are product defects resulting in as much as 5% of total production. The design used in this research is qualitative with case study techniques. The analysis techniques used in this research is descriptive analysis techniques with tool named fishbone diagram. The result showed that 72% of GMP aspects had been fulfilled but 28% had not been so the implementation of GMP was hampered. According to fishbone diagram result, there are four the inhibiting factor that have been identified.

GMP – нові вимоги до виробництва ветеринарних препаратів в Україні

At the current stage of the development of the veterinary pharmacy in Ukraine, the regulation of requirements to all stages of the life cycle of veterinary medicines (VM) is due to the establishment and implementation of national regulations of GMP. The purpose of our studing was to develop a legislative framework for the introduction GMP in production of VM in the algorithm: the legal framework, ready experts from GхP, informing producers. In order to achieve the objectives, the analysis and grouping of Ukrainian and European directives and standards that regulate the requirements for the production of veterinary medicines were conducted. To date, by Order No. 606 of 10.11.2017, the Ministry of Agrarian Policy and Food of Ukraine approved the Regulations and Rules of GMP. However, the primary authorization document for the conduct of economic activity is a license. The Resolution of the Cabinet of Ministers of Ukraine dated October 3, 2018 No. 808 approved the Licensing conditions for conducting economic activities for the production of veterinary medicines, which are consistent with the requirements of GMP for veterinary medicines, as well as one of the obligatory documents is Site Master File. The analysis of the SMF identifies manufacturers of VM that do not meet the established requirements for production conditions, technological processes, quality control, implementation of the pharmaceutical quality system and personnel training. The next task is to prepare experts in the field of inspection for compliance with GMP requirements for veterinary medicines, so within three years, the experts in the sector of good practices of the National Agency of State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives take on the positive experience of certified PIC / S inspectors, participate in joint inspections on Compliance with GMP European Veterinary Products. Informing manufacturers of VM is also important in this GMP implementation strategy. Every year, starting from 2014, State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives and fodder supplements, with the support of the State Service of Ukraine for Food Safety and Consumer Protection hold on international conferences and seminars with the participation of European and American experts where highlighted the peculiarities of implementation and maintenance of GMP requirements. Thus, the approval of the legislative framework, the preparation of experts on GxP and the clarification of new requirements for implementation of producers is a prerequisite for confirming the compliance of the GMP requirements of veterinary preparations in Ukraine.