Manufacturing Practices Research Articles

Innovations in Wind Turbine Blade Engineering: Exploring Materials, Sustainability, and Market Dynamics

This manuscript delves into the transformative advancements in wind turbine blade technology, emphasizing the integration of innovative materials, dynamic aerodynamic designs, and sustainable manufacturing practices. Through an exploration of the evolution from traditional materials to cutting-edge composites, the paper highlights how these developments significantly enhance the efficiency, durability, and environmental compatibility of wind turbines. Detailed case studies of notable global projects, such as the Hornsea Project One, the Gansu Wind Farm, and the Block Island Wind Farm, illustrate the practical applications of these technologies and their impact on energy production and sustainability. Additionally, the manuscript examines the critical role of regulatory frameworks and industry standards in fostering these technological advancements, ensuring safety, and promoting global adoption. By analyzing the current trends and future directions, this study underscores the potential of modern turbine technologies to meet the increasing global demand for renewable energy and contribute to sustainable development goals. The findings advocate for continued innovation and policy alignment to fully harness the potential of wind energy in the renewable energy landscape.

A Universal Framework for Skill-Based Cyber-Physical Production Systems

In the vision of smart manufacturing and Industry 4.0, it is vital to automate production processes. There is a significant gap in current practices, where the derivation of production processes from product data still heavily relies on human expertise, leading to inefficiencies and a shortage of skilled labor. This paper proposes a universal framework for skill-based cyber–physical production systems (CPPS) that formalizes production knowledge into machine-processable formats. Key contributions include a novel conceptual model for skill-based production processes and an automated method to derive production plans from high-level CPPS skills for production planning and execution. This framework aims to enhance smart manufacturing by enabling more efficient, transparent, and automated production planning, thereby addressing the critical gap in current manufacturing practices. The framework’s benefits include making production processes explainable, optimizing multi-criteria systems, and eliminating human biases in process selection. A case study illustrates the framework’s application, demonstrating its current capabilities and potential for modern manufacturing.

Sustainable practices in steel manufacturing: Substitution elasticities between waste, raw materials, and energy for greenhouse gas emission reduction

This study investigates the potential of waste utilization to mitigate greenhouse gas (GHG) emissions within the steel manufacturing industry. Utilizing a translog production function, we analyze the substitution elasticities among scrap steel, iron ore, and energy, exploring their roles in carbon reduction. Our approach incorporates the Resource Efficiency and Climate Change Mitigation model to simulate the impact of various waste utilization strategies on GHG emissions. The findings highlight that scrap steel and iron ore exhibit substitution dynamics. Iron ore and energy exhibit complementary relationship, and there is also a complementary relationship between scrap steel and energy but with lower elasticity, indicating that increasing scrap steel usage can significantly reduce emissions while decreasing iron ore demand. Specifically, enhancing the input efficiency of scrap steel in secondary steel production can reduce GHG emissions by over 8.3 tons for each additional ton produced—surpassing the impact of merely increasing the volume of reused material, which offers a reduction of more than 2.2 tons per ton. The strategies centered on reduction and recycling demonstrate even lower GHG reduction efficiency. The findings advocate for governmental intervention to promote and support waste reuse initiatives, highlighting the potential environmental benefits and efficiency gains from such policies.

Validation of chromatographic methods, TLC and HPLC, to quantify known radiochemical impurities and the radiochemical purity the radiopharmaceutical [177Lu]Lu-PSMA I&T

The Energy and Nuclear Research Institute (IPEN) is studying the production of the radiopharmaceutical [177Lu]Lu-PSMA I&T, in accordance with the good manufacturing practices recommended by the National Health Surveillance Agency (ANVISA), to be used in the therapy of prostate cancer. This work aims to validate chromatographic methods, Thin-Layer Chromatographic (TLC) and high-performance liquid chromatography (HPLC), to determine the radiochemical purity (RCP) of the product. The entire validation process of this work was based on ANVISA's RDC 166, 2017 and the Guide 10, version 1, 2017, guided the statistical treatments adopted. With the selectivity study we can observe that the presence of impurities or excess excipients in the sample does not interfere with the quantification of the product. The proposed methods were linear with linear correlation coefficients (r) above 0.99. The precision and repeatability presented relative standard deviation values lower than specified (RSD < 5 %). The small controlled variations in the method suggested for the robustness test also did not affect the radiochemical purity of the product. In view of the results and in accordance with the criteria established by the National Health Surveillance Agency (ANVISA), the two chromatographic methods were validated in accordance with RDC 166, 2017, proving to be selective, precise, linear and robust. The validation of TLC and HPLC methods enables their application in the batch release routine of the new radiopharmaceutical at Radiopharmacy Center of IPEN.

Critical barriers to adopt sustainable manufacturing practices in medium-sized ready-made garment manufacturing enterprises and their mitigation strategies

This study delves into the critical barriers hindering sustainable manufacturing practices in medium-sized ready-made garments manufacturing enterprises. Initially, barriers were identified through a literature review and expert opinions. Then, the fuzzy Delphi Method and expert consensus were used to prioritize the critical barriers. Finally, based on the insights from a focus group discussion and the supported literature, strategies to mitigate the identified critical barriers were formulated. In this study, the initial barriers identified encompassed various dimensions. The top three critical barriers were identified as higher prices of sustainable products, limited supplier commitment, and lack of access to information. Strategies to address these critical barriers include adopting collaborative business approaches, incorporating sustainability standards, investing in technology, implementing sustainable manufacturing techniques, and integrating green supply chain management practices. Overall, by focusing on these strategies, medium-sized garment manufacturing enterprises can enhance their sustainability efforts and gain economic, environmental, and social benefits.

Efficient optimization of the multi-response problem in the taguchi method through advanced data envelopment analysis formulations integration

This study introduces an innovative strategy to address the multi-response challenge inherent in the Taguchi Method, frequently encountered in the enhancement of production processes and productivity indices. By integrating the Taguchi Method with Data Envelopment Analysis (DEA), experimental trials are transformed into Decision Making Units (DMUs), with response variables categorized as inputs and outputs. Advanced DEA models, including simultaneous DEA and super-efficiency models, are employed to determine the DMUs’ relative and cross efficiencies, thus retaining the advantages of the Taguchi Design of Experiments (DoE) while offering an optimal solution for enhancing multiple quality responses. The superiority of this approach is validated by the Addictive Model for Factor Effects, demonstrating enhanced outcomes and reduced computational effort compared to existing empirical and scholarly solutions. These findings have significant implications for advancing manufacturing practices that require multi-response optimization, marking a notable contribution to the field.

Optimizing the Procedure for Manufacturing Clinical-grade Genetically Manipulated NK cells for Adoptive Immunotherapy

BackgroundEx vivo expanded natural killer (NK) cells hold significant potential as antitumor effector cells for adoptive immunotherapy. However, producing clinical-grade genetically modified NK cells in sufficient quantities presents a considerable challenge. MethodsWe tested RPMI 1640, KBM581, SCGM, NK MACS, X-VIVO 15, and AIM-V, each supplemented with fetal bovine serum (FBS), human AB serum, human platelet lysate (HPL), or Immune Cell Serum Replacement (SR) combined with feeder cells, to produce cytotoxic NK cells. Subsequent analyses were conducted to assess cell viability, expansion folds, cytotoxicity, immunophenotype, and transcriptome profile of NK cells under certain conditions. Furthermore, transfer plasmids varying in transgene size, promoter elements, backbones and packaging plasmids with different envelopes were used to transduce NK cells and differences in transduction efficiency were compared. Nucleofection was performed every two days from Day 0 to Day 12 to determine the optimal time window for gene editing. ResultsNK cells cultured in KBM581 medium supplemented with SR exhibited the best expansion, achieving over 5000-fold increase within two weeks and exceeding 25,000-fold expansion within three weeks. Additionally, NK cells cultured in KBM581 medium with human AB serum demonstrated the highest cytolytic activities and exhibited higher expression of NKp30, 2B4, PRF1, Granzyme B, and IL2RG. Baboon envelope (BaEV) pseudotyped lentivirus outperformed BaEV-Vesicular Stomatitis Virus type-G (VSVG) hybrid envelope lentivirus, achieving robust NK cell transduction. Additionally, efficient gene knockout efficiency was achieved in NK cells on day 4 to day 6 post feeder cell activation using LONZA DN-100 program, which can strike a balance between editing efficiency and cell expansion. ConclusionsThis research presents a Good Manufacturing Practice (GMP)-compliant protocol utilizing a feeder cell expansion system for the large-scale production of highly cytotoxic Natural Killer (NK) cells. The protocol facilitates genetic modification of these cells, positioning them as promising candidates for universal therapeutic applications in immunotherapy.

Design and Optimization of Steel Structures for Solar Panel Systems

Abstract: Structural components are fundamental for supporting mechanical machines in industrial settings. These structures are designed not only to bear the weight of the machines but also to withstand the vibrations generated during operation. The project at hand focuses on integrating basic structural sections to create a complete mechanical framework. Our goal is to collaborate with an industry specializing in support structures for various electrical units. From our initial analysis, we observed that many of these industries rely on conventional manufacturing practices and past experience to design structures, often leading to overdesign. No finite element analysis (FEA) or theoretical calculations are typically applied. We propose introducing modern FEA techniques and concepts to optimize and refine these designs for improved efficiency.

Exploring the Potential Synergies between Industry 5.0 and Green Lean Six Sigma for Sustainable Performance: A New Dimension of Operational Excellence

Today's companies are adopting a sustainable strategy, often in a reactive manner, to respond to customer demands, stakeholder concerns, and compliance with regulatory requirements, while seeking to proactively maintain a strong standing in the future market. This article explores the synergies between Industry 5.0 technologies and Green Lean Six Sigma (GLSS), highlighting how their integration can catalyse sustainable transformations in manufacturing. The study combines a literature review with empirical survey conducted across companies in various industrial sectors. The objective is to identify and examine potential synergies between Industry 5.0 technologies and Green Lean Six Sigma tools to improve the environmental impact of manufacturing companies. The results highlight the importance of Industry 5.0 technologies in boosting the efficiency of GLSS, thereby promoting more sustainable manufacturing practices. Key areas of synergy include sustainable process optimization, energy efficiency, sustainable personalization, data analytics for sustainability, and sustainable innovation. This article emphasizes the mutual benefits of integrating Industry 5.0 technologies with the Green Lean Six Sigma methodological framework. This combination reduces the consumption of materials and resources, improves energy efficiency, and stimulates innovation in favor of eco-responsible production. It calls for an integrated approach, considering technology, human resources, and processes, to enable manufacturing companies to achieve optimized operational performance while contributing to environmental sustainability.

THE EFFECTIVENESS OF TASK-BASED LEARNING MODULE (TBL) IN ENHANCING MASTERY OF GOOD MANUFACTURING PRACTICE (GMP) IN PHARMACEUTICAL ENGINEERING COURSES FOR CHINESE VOCATIONAL COLLEGES

The issuance of the guidelines for the modernization of vocational education in China by 2025 along with the “Opinions on Promoting the High-quality Development of Modern Vocational Education” highlights the importance of transforming the existing teaching methods and models along with improving the instructional methodologies of vocational education. Despite being a necessary course for pharmaceutical engineering professionals at colleges and universities, the Good Manufacturing Practice (GMP) course struggles to employ an updated teaching technique that is in congruence with contemporary developments. Therefore, this study aims to explore the impact of Task-Based Learning (TBL) on enhancing students' grades, interests, and proficiency in the GMP course. This study has taken into consideration the individual competence and ability of the students along with exploring the challenges faced by teachers in conducting TBL in enhancing mastery of GMP in pharmaceutical engineering courses for Chinese vocational colleges. For an in-depth analysis of this study, a total of 91 students who pursue bachelor degrees in China are selected to conduct the survey. Furthermore, a total of 4 teachers from two classes are selected for the interview, who have minimum 5 years of experience in GMP vocational courses. The results of this study highlight that TBL is significant in enhancing the ability and academic performance of the students. It has been identified that TBL teaching methods can be beneficial for teachers to increase the effectiveness of the instructional methods in vocational courses. However, it has also been identified that the skills of the teachers to stimulate critical thinking among the students are also an important aspect of TBL. The study is conducive to the integration of theoretical perspectives which elaborates on the significance of the study in terms of GMP in pharmaceutical engineering courses in the context of China.

Upgrading of Quality Control for Herbal Medicine Use in South Korea by Introducing an Accreditation System: a brief report.

This study aimed to present a government-led accreditation system for upgrading the quality control of herbal medicine by introducing the process and evaluation standard of external herbal dispensaries (EHDs) of traditional Korean medicine (TKM) clinics in South Korea 2018 to refer to other countries where herbal medicine were used similarly in Korea. We organized an EHD accreditation committee for the establishment of an accreditation system. The committee consisted of 9 experts an official of the Ministry of Health and Welfare (MoHW), a professor expert of TKM, a good manufacturing practice expert, a hazard analysis and critical control point expert, and an accreditation system expert. After 3 meetings, a draft of the evaluation standard and evaluation system was established in 2017. Based on the draft, a pilot test was conducted to determine the applicability of the evaluation standards in 2017. Two additional meeting was held to confirm the accreditation standards and was finalized in 2018. The evaluation standard for EHDs was developed. In the case of herbal medicine EHDs, the evaluation standard consisted of 9 evaluation categories, 25 evaluation parts, and 81 evaluation items were developed. The results of the evaluation of the pilot tests are as follows, and the results show that there is a deviation between the EHDs. As a world's first, Korea MoHW successfully launched the accreditation system for upgrading the quality control system of herbal medicine not approved by Korea's Ministry of Food and Drug Safety in 2018. Our report hope to provide a good reference to other countries where having similar herbal medicine system in South Korea hoping to make better quality control of herbal medicines.

A RELEVÂNCIA DOS PROGRAMAS DE AUTOCONTROLE NA SAÚDE PÚBLICA EM INDÚSTRIAS DE PRODUTOS DE ORIGEM ANIMAL

Self-Control Programs (PACs) are fundamental for the agroindustry, aiming at food safety and reducing risks to public health. Along with Good Manufacturing Practices (GMP), Standard Operational Hygiene Procedures (PPHO) and the Hazard Analysis and Critical Control Points Program (HACCP). The research aims to demonstrate the importance of PAC as a tool capable of minimizing and controlling levels of contamination, infection and/or food poisoning in the food industry, discussing the regulations issued by supervisory authorities on the quality, health and safety of food, as well as good practices in the production of products of animal origin. The importance of studying this topic is that it has great relevance due to the fact that it addresses the importance of the hygienic-sanitary and technological quality of raw materials, animal health and public health. The study was carried out using articles, books and academic sources through electronic searches in SciELO, Google Scholar, PUBMED, PubVet of relevance in addition to Laws and books, bibliographical research and insights into the need to highlight and demonstrate the importance of programs in the food industry. It was concluded that PACs are essential to reduce risks to public health and enhance food quality and safety for consumers.

Hybrid polymer composites of Terminalia chebula filler reinforced thermal and mechanical characterization of bagasse/tamarind seed

The development of manufacturing industries is crucial for national progress, with a growing emphasis on green and sustainable practices. This study investigates the development and performance of hybrid polymer composites based on poly lactic acid (PLA) reinforced with lignocellulosic fillers: bagasse fiber (BF), tamarind seed fiber (TSF), Terminalia chebula fiber (TCF), and a hybrid filler of bagasse, tamarind seed, and Terminalia chebula (BTSTCF). Five types of composites were fabricated with varying filler compositions: PLA, PLA/BF, PLA/TSF, PLA/TCF, and PLA/BTSTCF, consisting of 30% BF, TSF, or TCF with 70% PLA, and an additional 10% of each filler in the BTSTCF composite. The results demonstrated that the PLA/BTSTCF hybrid composite outperformed others regarding mechanical strength, thermal stability, and interfacial adhesion. Specifically, it exhibited superior flexural strength, impact strength, and tensile strength. The findings indicate that incorporating a combination of bagasse, tamarind seed, and Terminalia chebula fillers into PLA significantly enhances its properties and performance. This study contributes to advancing sustainable and green manufacturing practices and holds promise for economic growth through the development of high-performance, eco-friendly materials.

The Role of Circular Economy Principles in Revolutionising Sustainable Manufacturing Practices

The increasing recognition of the limitations inherent in the traditional linear economic model [1] has spurred interest in the Circular Economy (CE) as a transformative framework for sustainable manufacturing practices [2]. This literature review systematically explores the integration of CE principles, focusing on strategies such as reuse, remanufacturing and recycling, which aim to minimise waste and optimise resource utilisation throughout product lifecycles. A thorough examination of eco-design methodologies highlights the importance of product longevity, reparability and material recovery, while advanced technologies—including digitalisation, Internet of Things (IoT) applications and material recovery systems—are identified as critical enablers of circularity in manufacturing processes. We also address consumer-centric design as a vital aspect of CE integration, emphasising the role of user engagement and education in fostering sustainable behaviours and product acceptance. Furthermore, the analysis includes financial mechanisms and investment strategies essential for supporting the transition to circular practices, alongside performance metrics and circularity indicators for assessing effectiveness. The role of small and medium enterprises (SMEs) in circular manufacturing, along with the challenges and barriers to implementation, is critically evaluated. Finally, the review identifies future prospects and opportunities within the CE landscape, underscoring the need for collaborative efforts among stakeholders to advance sustainable manufacturing. This comprehensive examination provides valuable insights into the potential of CE principles to revolutionise manufacturing practices and contribute to long-term sustainability goals.

TDAD: Self-supervised industrial anomaly detection with a two-stage diffusion model

Visual anomaly detection has emerged as a highly applicable solution in practical industrial manufacturing, owing to its notable effectiveness and efficiency. However, it also presents several challenges and uncertainties. To address the complexity of anomaly types and the high cost associated with data annotation, this paper introduces a self-supervised learning framework called TDAD, based on a two-stage diffusion model. TDAD consists of three key components: anomaly synthesis, image reconstruction, and defect segmentation. It is trained end-to-end, with the goal of improving pixel-level segmentation accuracy of anomalies and reducing false detection rates. By synthesizing anomalies from normal samples, designing a diffusion model-based reconstruction network, and incorporating a multiscale semantic feature fusion module for defect segmentation, TDAD achieves state-of-the-art performance in image-level detection and anomaly localization on challenging and widely used datasets such as MVTec and VisA benchmarks.

New Pipeline for Analysing Fruit Proteolytic Products Used as Digestive Health Nutraceuticals

Proteolytic products are extensively used in the nutraceutical sector to improve protein digestion and muscle quality in target populations (e.g., athletes or elderly). These products are processed using techniques that often lead to low purity but competitive pricing. Despite their widespread use and well-established production methods, the industry lacks standardized analytical methods for assessing these products and detecting potential fraud. This study proposes a comprehensive and harmonized pipeline for their analysis, which includes quantifying total soluble protein and proteolytic activity, as well as the determination of product stability and protein profile using SDS-PAGE and proteomic techniques. Despite the fact that protease extracts from pineapple had the highest protein content, most of the bromelain remained inactive, unlike in kiwi and papaya. SDS-PAGE revealed partial protein degradation of pineapple extracts, whereas kiwi extracts reflected a lower purification level but a higher protein integrity. The application of proteomic approaches strengthened the identification and origin tracing of the proteases. This study contributes to the development of a robust framework for analyzing proteolytic extracts, spanning from soluble protein quantification to protein profiling and activity determination. It may also ensure reliable supplier selection, high-quality manufacturing practices, and the implementation of optimal storage and formulation strategies in the nutraceutical industry.

Bacterial cellulose materials in sustainable energy devices: A review.

This article provides a comprehensive review of the processing and applications of bacterial cellulose (BC) for energy conversion and storage devices. These emerging technologies enable the transformation of sustainable energy sources into electricity. Once converted, energy storage devices are vital for stable energy supply. To promote green manufacturing practices in this field, bio-based materials are explored as alternative materials for energy devices, addressing the growing demand for sustainable solutions. From a research and development perspective, the materials chosen for energy devices must exhibit exceptional mechanical, electrical, and thermal properties, along with the necessary chemical reactivity to unlock new applications. Furthermore, for successful commercialization and industrialization, these materials must be suitable for large-scale production within practical timeframes. BC fulfills all of these requirements. The review begins with an overview of BC growth, detailing the composition and operating parameters of the culture medium and the design of bioreactors for large-scale production. It then defines and summarizes both in-situ and ex-situ modifications and processing strategies, offering a comprehensive perspective on these techniques. Unique and interesting properties linking BC's structure to its properties are reviewed to demonstrate its potential as a substitute for benchmark materials. The exceptional performance and synergistic effects of BC-derived hybrid materials highlight their potential for state-of-the-art applications in energy devices, and are suitable for the next-generation energy devices. The papers reviewed in this work have gained significant attention and been widely cited over the past 10years for their relevance to various practical applications, allowing readers to have a better understanding in development of BC based materials for energy conversion and conversion devices.

Innovative risk management techniques in food safety: A review of best practices and emerging trends

Effective risk management in food safety is critical to ensuring consumer protection and maintaining the integrity of global food supply chains. Traditional approaches, such as Hazard Analysis and Critical Control Points (HACCP) and Good Manufacturing Practices (GMP), have long been the foundation of food safety risk management. However, with the increasing complexity of food production and distribution, new challenges demand more advanced techniques. This review explores innovative risk management methods, focusing on best practices and emerging trends that are transforming food safety. Technological advancements are driving much of this innovation. Predictive analytics and machine learning now allow for real-time monitoring and hazard detection, improving the accuracy of risk assessments. Blockchain technology is being leveraged for enhanced traceability and transparency in the supply chain, ensuring faster recall management and improved accountability. The integration of IoT (Internet of Things) sensors provides continuous monitoring of environmental factors like temperature and humidity, which are critical in preventing contamination, especially in perishable goods. Additionally, risk-based inspection systems, supported by regulatory frameworks such as the Food Safety Modernization Act (FSMA), are becoming more prevalent, prioritizing resources where risks are highest. Emerging trends such as artificial intelligence (AI) for predictive risk management, big data analytics, and sustainability-driven risk approaches are reshaping the landscape. These innovations not only enhance risk mitigation but also align with consumer demands for greater transparency and environmental responsibility. Despite challenges such as cost, data privacy, and regulatory hurdles, the future of food safety lies in the continued development and adoption of these advanced techniques. This review highlights the potential of these innovative practices to improve food safety standards and protect public health in an increasingly interconnected world. Keywords: Innovative, Risk Management, Food Safety, Review.

Exploring low temperature-sputtered indium tin oxide (ITO) as an anti-reflection layer for silicon solar cells

Abstract This paper tackles challenges in silicon (Si) solar cells, specifically the use of hazardous Phosphorus Oxychloride (POCl3) for emitter formation and silane/ammonia for the Anti-Reflective Coating (ARC) layer, accompanied by high-temperature metallization. The study proposes an eco-friendly ARC layer process, replacing toxic materials. Indium Tin Oxide (ITO) with a refractive index of ∼2.0 is suggested as a non-toxic substitute for SiN x in the ARC layer. ITO enables fine-tuning of optical parameters and, with its electrical properties, supports low-resistivity contacts through efficient, low-temperature metallization processes. ITO-passivated solar cells with Ag polymer paste as a front contact exhibit promising characteristics: a commendable photocurrent density (J sc) of 20 mA cm−2 at 850 °C, low series resistance (R s) of 1.9 Ω, and high shunt resistance (R shunt) of 28.9 Ω, as demonstrated by illuminated I–V measurements. Implementing ITO as the ARC on a less toxic emitter junction enhances Si solar cells’ current density gain, minimizing current leakage during high-temperature processing. In conclusion, adopting less toxic materials and employing low-temperature processing in passive silicon solar cell fabrication presents an attractive alternative for cost reduction and contributes to environmentally sustainable practices in green manufacturing.

Navigating the Regulatory Maze: The Vital Role of Regulatory Affairs in Pharmaceutical Safety and Quality

The real struggle of pharmaceutical industries for survival lies in performing processes by following the guidelines of various regulatory authorities around the globe to provide assured quality of the process under regulations [1]. A profession under-regulated industry, such as that controlling pharmaceuticals, medical devices, energy, and banking, is called Regulatory Affairs (RA) [2]. They may involve minor or major multinational corporations, including innovative biotechnology companies, which have a specific meaning and a separate specialized depart-ment of RA professionals. This department helps to guide the company on the regional and global laws and regulations set forth by different regulatory authorities and helps safeguard the products’ life cycle. The purpose of regulatory departments or pro-fessionals is to develop and promote heavily controlled therapeutic or pharmaceutical goods and build a platform for marketing approval. In addition to this, RA in the pharmaceutical industry is comparatively a new field to safeguard public well-being by monitoring the safety and efficacy of the products [3]. Furthermore, in the late 1950s, multiple tragedies resulted in an increase in legislation for pharmaceutical goods’ quality, safety, and efficacy. As a part of this, strict norms were made for Marketing Authorization (MA) and Good Manufacturing Practice (GMP) [4]. These tragedies included (i) sulphanilamide elixir; (ii) vac-cine tragedy; and (iii) thalidomide tragedy [4]. The present article covers the regulatory affairs’ responsibilities and importance in the context of pharmaceutical industries.