Displaying publications 1 - 20 of 120 in total

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  1. Fulltext Detecting industrial motor faults with current signatures
    Krishnan S, Vengadasalam V
    F1000Res, 2021;10:903.
    PMID: 36398279 DOI: 10.12688/f1000research.54266.1
    Background: A major player in industry is the induction motor. The constant motion and mechanical nature of motors causes much wear and tear, creating a need for frequent maintenance such as changing contact brushes. Unmannered and infrequent monitoring of motors, as is common in the industry, can lead to overexertion and cause major faults. If a motor fault is detected earlier through the use of automated fault monitoring, it could prevent minor faults from developing into major faults, reducing the cost and down-time of production due the motor repairs. There are few available methods to detect three-phase motor faults. One method is to analyze average vibration signals values of V, I, pf, P, Q, S, THD and frequency. Others are to analyze instantaneous signal signatures of V and I frequencies, or V and I trajectory plotting a Lissajous curve. These methods need at least three sensors for current and three for voltage for a three-phase motor detection. Methods: Our proposed method of monitoring faults in three-phase industrial motors uses Hilbert Transform (HT) instantaneous current signature curve only, reducing the number of sensors required. Our system detects fault signatures accurately at any voltage or current levels, whether it is delta or star connected motors. This is due to our system design, which incorporates normalized curves of HT in the fault analysis database. We have conducted this experiment in our campus laboratory for two different three-phase motors with four different fault experiments. Results: The results shown in this paper are a comparison of two methods, the V and I Lissajous trajectory curve and our HT instantaneous current signature curve. Conclusion: We have chosen them as our benchmark as their fault results closely resemble our system results, but our system benefits such as universality and a cost reduction in sensors of 50%.
    Matched MeSH terms: Quality Control*
  2. The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise
    Schiestl M, Li J, Abas A, Vallin A, Millband J, Gao K, et al.
    Biologicals, 2014 Mar;42(2):128-32.
    PMID: 24373974 DOI: 10.1016/j.biologicals.2013.11.009
    A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles on the role of the quality assessment in a biosimilar evaluation are widely understood and agreed, detailed discussions have not been published yet. We try to bridge this gap by presenting a case study exercise based on fictional but realistic data to highlight key principles of an evaluation to determine the degree of similarity at the quality level. The case study comprises three examples for biosimilar monoclonal antibody candidates. The first describes a highly similar quality profile whereas the second and third show greater differences to the reference biotherapeutic product. The aim is to discuss whether the presented examples can be qualified as similar and which additional studies may be helpful in enabling a final assessment. The case study exercise was performed at the WHO implementation workshop for the WHO guidelines on quality assessment of similar biotherapeutic products held in Xiamen, China, in May 2012. The goal was to illustrate the interpretation of the comparative results at the quality level, the role of the quality assessment in the entire biosimilarity exercise and its influence on the clinical evaluation. This paper reflects the outcome of the exercise and discussion from Xiamen.
    Matched MeSH terms: Quality Control*
  3. A review on matcha: Chemical composition, health benefits, with insights on its quality control by applying chemometrics and multi-omics
    Phuah YQ, Chang SK, Ng WJ, Lam MQ, Ee KY
    Food Res Int, 2023 Aug;170:113007.
    PMID: 37316075 DOI: 10.1016/j.foodres.2023.113007
    This review discussed the origin, manufacturing process, chemical composition, factors affecting quality and health benefits of matcha (Camellia sinensis), and the application of chemometrics and multi-omics in the science of matcha. The discussion primarily distinguishes between matcha and regular green tea with processing and compositional factors, and demonstrates beneficial health effects of consuming matcha. Preferred Reporting Items for Systematic Reviews and Meta-Analyses was adopted to search for relevant information in this review. Boolean operators were incorporated to explore related sources in various databases. Notably, climate, cultivar, maturity of tea leaves, grinding process and brewing temperature impact on the overall quality of matcha. Besides, sufficient shading prior to harvesting significantly increases the contents of theanine and chlorophyll in the tea leaves. Furthermore, the ground whole tea leaf powder delivers matcha with the greatest benefits to the consumers. The health promoting benefits of matcha are mainly contributed by its micro-nutrients and the antioxidative phytochemicals, specifically epigallocatechin-gallate, theanine and caffeine. Collectively, the chemical composition of matcha affected its quality and health benefits significantly. To this end, more studies are required to elucidate the biological mechanisms of these compounds for human health. Chemometrics and multi-omics technologies are useful to fill up the research gaps identified in this review.
    Matched MeSH terms: Quality Control
  4. Fulltext Phytochemistry, quality control and medicinal uses of Saffron (Crocus sativus L.): an updated review
    Aissa R, Ibourki M, Ait Bouzid H, Bijla L, Oubannin S, Sakar EH, et al.
    J Med Life, 2023 Jun;16(6):822-836.
    PMID: 37675158 DOI: 10.25122/jml-2022-0353
    Saffron, botanically known as Crocus sativus L., is renowned as the world's most expensive spice and has been utilized in various fields since ancient times. Extensive scientific research has been conducted on Crocus sativus (C. sativus), focusing on its phytochemical composition, diverse applications, and biological activities. C. sativus phytochemicals consist mainly of three compounds, namely crocin, picrocrocin, and safranal, which are responsible for most of its properties. Saffron is rich in bioactive compounds, more than 150 of which have been isolated. Owing to its unique composition and properties, saffron is used in various fields, such as the food industry, perfumery, cosmetics, pharmaceutics, and medicine. However, the high economic value of saffron makes it susceptible to adulteration and various fraudulent practices. To deal with this issue, a number of methods and techniques have been developed to authenticate and determine adulterants in saffron. This paper presents a bibliometric study of saffron based on the Web of Science database, analyzing 3,735 studies published between 2000 and 2021. The study also examined author participation and collaboration networks among countries. Production, transformation, chemical composition, methods of adulteration detection, uses, and health properties of saffron are also discussed.
    Matched MeSH terms: Quality Control
  5. Fulltext Malaysian Journal of Medical Sciences' Publishing Report (2014-2015)
    Zulkapli NA, Sobi S, Mohd Zubaidi NA, Abdullah JM
    Malays J Med Sci, 2016 Jul;23(4):1-4.
    PMID: 27660539 DOI: 10.21315/mjms2016.23.4.1
    The Malaysian Journal of Medical Sciences (MJMS) has conducted a simple analysis of its scholarly publication, based on the auto-generated data compiled from ScholarOne Manuscripts(™), an innovative, web-based, submission and peer-review workflow solution for scholarly publishers. The performance of the MJMS from 2014-2015 is reported on in this editorial, with a focus on the pattern of manuscript submission, geographical contributors and the acceptance-rejection rate. The total number of manuscript submissions has increased from 264 in 2014, to 272 in 2015. Malaysians are the main contributors to the MJMS. The total number of manuscript rejections following the review process was 79 (29.9%) in 2014, increasing to 92 (33.8%) the following year, in accordance with the exacting quality control criteria applied by the journal's editor to the submitted manuscripts.
    Matched MeSH terms: Quality Control
  6. Fulltext Optimal path test data generation based on hybrid negative selection algorithm and genetic algorithm
    Mohi-Aldeen SM, Mohamad R, Deris S
    PLoS One, 2020;15(11):e0242812.
    PMID: 33253281 DOI: 10.1371/journal.pone.0242812
    Path testing is the basic approach of white box testing and the main approach to solve it by discovering the particular input data of the searching space to encompass the paths in the software under test. Due to the increasing software complexity, exhaustive testing is impossible and computationally not feasible. The ultimate challenge is to generate suitable test data that maximize the coverage; many approaches have been developed by researchers to accomplish path coverage. The paper suggested a hybrid method (NSA-GA) based on Negative Selection Algorithm (NSA) and Genetic Algorithm (GA) to generate an optimal test data avoiding replication to cover all possible paths. The proposed method modifies the generation of detectors in the generation phase of NSA using GA, as well as, develops a fitness function based on the paths' prioritization. Different benchmark programs with different data types have been used. The results show that the hybrid method improved the coverage percentage of the programs' paths, even for complicated paths and its ability to minimize the generated number of test data and enhance the efficiency even with the increased input range of different data types used. This method improves the effectiveness and efficiency of test data generation and maximizes search space area, increasing percentage of path coverage while preventing redundant data.
    Matched MeSH terms: Quality Control*
  7. Fulltext Sustainable Palm Oil-The Role of Screening and Advanced Analytical Techniques for Geographical Traceability and Authenticity Verification
    Ramli US, Tahir NI, Rozali NL, Othman A, Muhammad NH, Muhammad SA, et al.
    Molecules, 2020 Jun 25;25(12).
    PMID: 32630515 DOI: 10.3390/molecules25122927
    Palm oil production from oil palm (Elaeis guineensis Jacq.) is vital for the economy of Malaysia. As of late, sustainable production of palm oil has been a key focus due to demand by consumer groups, and important progress has been made in establishing standards that promote good agricultural practices that minimize impact on the environment. In line with the industrial goal to build a traceable supply chain, several measures have been implemented to ensure that traceability can be monitored. Although the palm oil supply chain can be highly complex, and achieving full traceability is not an easy task, the industry has to be proactive in developing improved systems that support the existing methods, which rely on recorded information in the supply chain. The Malaysian Palm Oil Board (MPOB) as the custodian of the palm oil industry in Malaysia has taken the initiative to assess and develop technologies that can ensure authenticity and traceability of palm oil in the major supply chains from the point of harvesting all the way to key downstream applications. This review describes the underlying framework related to palm oil geographical traceability using various state-of-the-art analytical techniques, which are also being explored to address adulteration in the global palm oil supply chain.
    Matched MeSH terms: Quality Control*
  8. The autopsy--the ultimate medical consultation
    Pathmanathan R
    Malays J Pathol, 1988 Aug;10:7-13.
    PMID: 3252081
    Matched MeSH terms: Quality Control
  9. Evaluation of quality parameters for fresh, used and recycled palm olein
    Khor YP, Sim BI, Abas F, Lai OM, Wang Y, Nehdi IA, et al.
    J Sci Food Agric, 2019 Dec;99(15):6989-6997.
    PMID: 31414493 DOI: 10.1002/jsfa.9989
    BACKGROUND: Recycled oil has emerged as a significant food safety issue and poses a major threat to public health. To date, very limited studies have been conducted aiming to detect the adulteration of used and recycled palm olein in refined, bleached and deodorized palm olein (RBDPO). In the present study, oil samples that underwent controlled heating and deep-frying studies were refined using the common oil refining procedure to simulate the production of recycled oil. Polymerized triacylglycerol (PTG), oxidized monomeric triacylglycerols (oxTAGs), such as epoxy, keto and hydroxy acids, and caprylic acid have been proposed as potential indicators for tracking the adulteration of recycled oil.

    RESULTS: For PTG, triacylglycerol oligomers and dimers showed a significant increase (P controlling the adulteration of used and recycled palm olein in RBDPO for the protection of the health and safety of consumers. © 2019 Society of Chemical Industry.

    Matched MeSH terms: Quality Control
  10. Fulltext The control chart technique for the detection of the problem of bad data in state estimation power system
    Khan, Zahid, Radzuan Razali, Hanita Daud, Nursyarizal Mohd Nor, Fotuhi-Firuzabad, Mahmud
    Pertanika Journal of Science & Technology, 2017;25(3):825-834.
    MyJurnal
    State estimation plays a vital role in the security analysis of a power system. The weighted least squares method is one of the conventional techniques used to estimate the unknown state vector of the power system. The existence of bad data can distort the reliability of the estimated state vector. A new algorithm based on the technique of quality control charts is developed in this paper for detection of bad data. The IEEE 6-bus power system data are utilised for the implementation of the proposed algorithm. The output of the study shows that this method is practically applicable for the separation of bad data in the problem of power system state estimation.
    Matched MeSH terms: Quality Control
  11. Fulltext Assessment of blurring effect and its associated factors by using imagej: a multiparameter double holes contrast-detail phantom study
    Nur Farahana Pauzi, Zafri Azran Abdul Majid, Wan Muhamad Nasuha Wan Hussin, Abdul Halim Sapuan, Mohd Zulfaezal Che Azemin
    International Journal of Allied Health Sciences, 2017;1(2):107-119.
    MyJurnal
    X-ray is produced in form of divergent beam. The beam divergence results to blurring effect that influences image diagnosis. Thus, the blurring effect assessment should be enrolled within the quality control (QC) program of an imaging unit.
    Matched MeSH terms: Quality Control
  12. Integrated comparative metabolite profiling via NMR and GC-MS analyses for tongkat ali (Eurycoma longifolia) fingerprinting and quality control analysis
    Serag A, Zayed A, Mediani A, Farag MA
    Sci Rep, 2023 Feb 13;13(1):2533.
    PMID: 36781893 DOI: 10.1038/s41598-023-28551-x
    Tongkat ali commonly known as Malaysian Ginseng (Eurycoma longifolia) is a herbal root worldwide available in nutraceuticals, either as a crude powder or capsules blended with other herbal products. Herein, a multiplexed metabolomics approach based on nuclear magnetic resonance (NMR) and solid-phase microextraction combined with gas chromatography-mass spectrometry (SPME-GC-MS) was applied for authentic tongkat ali extract vs some commercial products quality control analysis. NMR metabolite fingerprinting identified 15 major metabolites mostly ascribed to sugars, organic and fatty acids in addition to quassinoids and cinnamates. Following that, multivariate analysis as the non-supervised principal component analysis (PCA) and supervised orthogonal partial least squares-discriminant analysis (OPLS-DA) were applied revealing that differences were related to fatty acids and 13,21-dihydroeurycomanone being more enriched in authentic root. SPME-GC-MS aroma profiling led to the identification of 59 volatiles belonging mainly to alcohols, aldehydes/furans and sesquiterpene hydrocarbons. Results revealed that aroma of commercial products showed relatively different profiles being rich in vanillin, maltol, and methyl octanoate. Whereas E-cinnamaldehyde, endo-borneol, terpinen-4-ol, and benzaldehyde were more associated to the authentic product. The present study shed the light for the potential of metabolomics in authentication and standardization of tongkat ali and identification of its true flavor composition.
    Matched MeSH terms: Quality Control
  13. A Review of Recent Progresses on Olive Oil Chemical Profiling, Extraction Technology, Shelf-life, and Quality Control
    Gagour J, Hallouch O, Asbbane A, Bijla L, Laknifli A, Lee LH, et al.
    Chem Biodivers, 2024 Apr;21(4):e202301697.
    PMID: 38345352 DOI: 10.1002/cbdv.202301697
    Olive oil (OO) is widely recognized as a main component in the Mediterranean diet owing to its unique chemical composition and associated health-promoting properties. This review aimed at providing readers with recent results on OO physicochemical profiling, extraction technology, and quality parameters specified by regulations to ensure authentic products for consumers. Recent research progress on OO adulteration were outlined through a bibliometric analysis mapping using Vosviewer software. As revealed by bibliometric analysis, richness in terms of fatty acids, pigments, polar phenolic compounds, tocopherols, squalene, sterols, and triterpenic compounds justify OO health-promoting properties and increasing demand on its global consumption. OO storage is a critical post-processing operation that must be optimized to avoid oxidation. Owing to its great commercial value on markets, OO is a target to adulteration with other vegetable oils. In this context, different chemometric tools were developed to deal with this problem. To conclude, increasing demand and consumption of OO on the global market is justified by its unique composition. Challenges such as oxidation and adulteration stand out as the main issues affecting the OO market.
    Matched MeSH terms: Quality Control
  14. Optimal implementation of low impact development for urban stormwater quantity and quality control using multi-objective optimization
    Rezaei AR, Ismail Z, Niksokhan MH, Dayarian MA, Ramli AH, Yusoff S
    Environ Monit Assess, 2021 Mar 31;193(4):241.
    PMID: 33791871 DOI: 10.1007/s10661-021-09010-4
    Stormwater runoff is a major concern in urban areas which is mostly the result of vast urbanization. To reduce urban stormwater runoff and improve water quality, low impact development (LID) is used in urban areas. Therefore, it is vital to find the optimal combination of LID controls to achieve maximum reduction in both stormwater runoff and pollutants with optimal cost. In this study, a simulation-optimization model was developed by linking the EPA Storm Water Management Model (SWMM) to the Multi-Objective Particle Swarm Optimization (MOPSO) using MATLAB. The coupled model could carry out multi-objective optimization (MOO) and find potential solutions to the optimization objectives using the SWMM simulation model outputs. The SWMM model was developed using data from the BUNUS catchment in Kuala Lumpur, Malaysia. The total suspended solids (TSS) and total nitrogen (TN) were selected as pollutants to be used in the simulation model. Vegetated swale and rain garden were selected as LID controls for the study area. The LID controls were assigned to the model using the catchment characteristics. The target objectives were to minimize peak stormwater runoff, TSS, and TN with the minimum number of LID controls applications. The LID combination scenarios were also tested in SWMM to identify the best LID types and combination to achieve maximum reduction in both peak runoff and pollutants. This study found that the peak runoff, TSS, and TN were reduced by 13%, 38%, and 24%, respectively. The optimal number of LID controls that could be used at the BUNUS catchment area was also found to be 25.
    Matched MeSH terms: Quality Control
  15. Fulltext Use of probiotics in clinical practice with special reference to diarrheal diseases: A position statement of the Malaysian Society of Gastroenterology and Hepatology
    Lee YY, Leow AH, Chai PF, Raja Ali RA, Lee WS, Goh KL
    JGH Open, 2021 Jan;5(1):11-19.
    PMID: 33490608 DOI: 10.1002/jgh3.12469
    Probiotics comprise a large group of microorganisms, which have different properties and thus confer different benefits. The use of probiotics has shown promising results in the management of diarrheal diseases. While the availability of probiotic products has flourished in the marketplace, there is limited guidance on the selection of probiotics for clinical use. This position paper is aimed at informing clinicians about the proper selection criteria of probiotics based on current evidence on strain-specific efficacy and safety for the management of diarrheal diseases. Members of the working group discussed issues on probiotic use in clinical practice, which were then drafted into statements. Literature to support or refute the statements were gathered through a search of medical literature from 2011 to 2020. Recommendations were formulated based on the drafted statements and evidence gathered, revised as necessary, and finalized upon agreement of all members. Twelve statements and recommendations were developed covering the areas of quality control in the manufacturing of probiotics, criteria for selection of probiotics, and established evidence for use of probiotics in diarrheal diseases in adults and children. Recommendations for the use of specific probiotic strains in clinical practice were categorized as proven and probable efficacy based on strength of evidence. Robust evidence is available to support the use of probiotics for diarrheal diseases in clinical practice. Based on the results obtained, we strongly advocate the careful evaluation of products, including manufacturing practices, strain-specific evidence, and contraindications for at-risk populations when choosing probiotics for use in clinical practice.
    Matched MeSH terms: Quality Control
  16. Fulltext Application of molecularly imprinted polymers in food sample analysis – a perspective
    Lok, C.M., Son, R.
    International Food Research Journal, 2009;16(2):127-140.
    MyJurnal
    Since the introduction of the molecularly imprinting technology (MIT) in 1970s, it becomes an emerging technology with the potential for wide-ranging applications in food manufacturing, processing, analysis and quality control. It has been successfully applied in food microbiology, removal of undesirable components
    from food matrices, detection of hazardous residues or pollutants and sensors. Molecularly imprinted solid-phase extraction (MISPE) is the most common application so far. The review describes the methods of making the molecularly imprinted polymer systems, the application of the technology in food safety issues and the remaining challenges.
    Matched MeSH terms: Quality Control
  17. Fulltext Embedded Smart Antenna for Non-Destructive Testing and Evaluation (NDT&E) of Moisture Content and Deterioration in Concrete
    Teng KH, Kot P, Muradov M, Shaw A, Hashim K, Gkantou M, et al.
    Sensors (Basel), 2019 Jan 28;19(3).
    PMID: 30696110 DOI: 10.3390/s19030547
    : Concrete failure will lead to serious safety concerns in the performance of a building structure. It is one of the biggest challenges for engineers to inspect and maintain the quality of concrete throughout the service years in order to prevent structural deterioration. To date, a lot of research is ongoing to develop different instruments to inspect concrete quality. Detection of moisture ingress is important in the structural monitoring of concrete. This paper presents a novel sensing technique using a smart antenna for the non-destructive evaluation of moisture content and deterioration inspection in concrete blocks. Two different standard concrete samples (United Kingdom and Malaysia) were investigated in this research. An electromagnetic (EM) sensor was designed and embedded inside the concrete to detect the moisture content within the structure. In addition, CST microwave studio was used to validate the theoretical model of the EM sensor against the test data. The results demonstrated that the EM sensor at 2.45 GHz is capable of detecting the moisture content in the concrete with linear regression of R² = 0.9752. Furthermore, identification of different mix ratios of concrete were successfully demonstrated in this paper. In conclusion, the EM sensor is capable of detecting moisture content non-destructively and could be a potential technique for maintenance and quality control of the building performance.
    Matched MeSH terms: Quality Control
  18. Fulltext Economic-statistical design of synthetic np chart with estimated process parameter
    Lee MH, Khoo MBC, Chew X, Then PHH
    PLoS One, 2020;15(4):e0230994.
    PMID: 32267874 DOI: 10.1371/journal.pone.0230994
    The economic-statistical design of the synthetic np chart with estimated process parameter is presented in this study. The effect of process parameter estimation on the expected cost of the synthetic np chart is investigated with the imposed statistical constraints. The minimum number of preliminary subgroups is determined where an almost similar expected cost to the known process parameter case is desired for the given cost model parameters. However, the available number of preliminary subgroups in practice is usually limited, especially when the number of preliminary subgroups is large. Consequently, the optimal chart parameters of the synthetic np chart are computed by considering the practical number of preliminary subgroups in which the cost function is minimized. This leads to a lower expected cost compared to that of adopting the optimal chart parameter corresponding to the known process parameter case.
    Matched MeSH terms: Quality Control
  19. Evaluation of the stability of Yamakagashi (Rhabdophis tigrinus) Equine Antivenom after 20 years storage
    Morokuma K, Matsumura T, Yamamoto A, Sakai A, Hifumi T, Ato M, et al.
    Trop Biomed, 2021 Jun 01;38(2):111-118.
    PMID: 34172698 DOI: 10.47665/tb.38.2.042
    In 2000, an equine Yamakagashi (Rhabdophis tigrinus) antivenom (Lot 0001) was testmanufactured as an unapproved drug for treatment of Yamakagashi bites. It was stocked on the premise of super-legal use from the viewpoint of emergency health crisis management. The antivenom showed a strong neutralizing ability against the hemorrhagic and coagulation activity of the Yamakagashi venom in its potency test. One vial of the antivenom can effectively neutralize at least about 4 mg of Yamakagashi venom. Its efficacy has also been confirmed in patients with severe cases of R. tigrinus bite that has been used in emergency. In 2020, this antivenom (Lot 0001) has reached 20 years after its production. To evaluate the integrity and potency of the antivenom, quality control, safety and potency tests had been conducted almost every year since 2012. Physical and chemical tests (property test, moisture content test, insoluble foreign matter test, osmotic pressure ratio test, pH test, protein content test, endotoxin test, sterility test) of the antivenom, showed no significant changes throughout the years, when compared to the results immediately after its production in 2000. All the parameters measured were also within the standard values. In animal safety tests (test for absence of toxicity and pyrogen), there was no change in the test results during the storage period and no abnormalities were observed. The potency test (anti-coagulant activity) after 20 years of the product, showed the same potency as those recorded immediately after production. Therefore, in all of the stability monitoring tests conducted so far, the product did not show any significant change compared to the results immediately after production. This confirms the stability of the product during the stockpiling period to the present, that is, 20 years after production.
    Matched MeSH terms: Quality Control
  20. Quality management overview for the production of a tissue-engineered human skin substitute in Malaysia
    Seet WT, Mat Afandi MA, Ishak MF, Hassan MNF, Ahmat N, Ng MH, et al.
    Stem Cell Res Ther, 2023 Oct 20;14(1):298.
    PMID: 37858277 DOI: 10.1186/s13287-023-03536-9
    Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting materials, including tissue samples, culture media, reagents, and consumables must be verified and tested to confirm their safety, potency, and sterility. The final products should also undergo a QC testing series to guarantee product safety, efficacy, and overall quality. The aseptic techniques of cleanroom operators and the environmental conditions of the facility are also important, as they directly influence the manufacturing of good-quality products. Hence, personnel training and environmental monitoring are necessary to maintain GMP compliance. Furthermore, risk management implementation is another important aspect of QA/QC, as it is used to identify and determine the risk level and to perform risk assessments when necessary. Moreover, procedures for non-conformance reporting should be established to identify, investigate, and correct deviations that occur during manufacturing. This paper provides insight and an overview of the QA/QC aspect during MyDerm® manufacturing in a GMP-compliant facility in the Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia.
    Matched MeSH terms: Quality Control
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