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Halal pharmaceutical industry: opportunities and challenges

Nor Norazmi M, Lim LS

Trends Pharmacol. Sci., 2015 Aug;36(8):496-7.
PMID: 26187623 DOI: 10.1016/j.tips.2015.06.006

The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, well-regulated, and harmonized accreditation and halal management system.

Matched MeSH terms: Drug Industry/standards
Drug policies in Malaysia

James PF

Lancet, 1984 Feb 25;1(8374):453.
PMID: 6142178
Matched MeSH terms: Drug Industry/standards*
Fulltext Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Juhlin K, Karimi G, Andér M, Camilli S, Dheda M, Har TS, et al.

Drug Saf, 2015 Apr;38(4):373-82.
PMID: 25687792 DOI: 10.1007/s40264-015-0271-2

Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to patient safety. Spontaneous adverse drug reaction reporting systems can contribute to identification of quality problems that cause unwanted and/or harmful effects, and to identification of clusters of lack of efficacy. In 2011, the Uppsala Monitoring Centre (UMC) constructed a novel algorithm to identify reporting patterns suggestive of substandard medicines in spontaneous reporting, and applied it to VigiBase(®), the World Health Organization's global individual case safety report database. The algorithm identified some historical clusters related to substandard products, which were later able to be confirmed in the literature or by contact with national centres (NCs). As relevant and detailed information is often lacking in the VigiBase reports but might be available at the reporting NC, further evaluation of the algorithm was undertaken with involvement from NCs.

Matched MeSH terms: Drug Industry/standards*
Fulltext Health monitoring of civil infrastructure and materials

Aggelis DG, Alver N, Chai HK

ScientificWorldJournal, 2014;2014:435238.
PMID: 24701167 DOI: 10.1155/2014/435238
Matched MeSH terms: Construction Industry/standards*
Fulltext Regulatory guidelines for biosimilars in Malaysia

Abas A

Biologicals, 2011 Sep;39(5):339-42.
PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.

Matched MeSH terms: Drug Industry/standards*
BIA-Obesity (Business Impact Assessment-Obesity and population-level nutrition): A tool and process to assess food company policies and commitments related to obesity prevention and population nutrition at the national level

Sacks G, Vanderlee L, Robinson E, Vandevijvere S, Cameron AJ, Ni Mhurchu C, et al.

Obes Rev, 2019 11;20 Suppl 2:78-89.
PMID: 31317645 DOI: 10.1111/obr.12878

Addressing obesity and improving the diets of populations requires a comprehensive societal response. The need for broad-based action has led to a focus on accountability of the key factors that influence food environments, including the food and beverage industry. This paper describes the Business Impact Assessment-Obesity and population-level nutrition (BIA-Obesity) tool and process for benchmarking food and beverage company policies and practices related to obesity and population-level nutrition at the national level. The methods for BIA-Obesity draw largely from relevant components of the Access to Nutrition Index (ATNI), with specific assessment criteria developed for food and nonalcoholic beverage manufacturers, supermarkets, and chain restaurants, based on international recommendations and evidence of best practices related to each sector. The process for implementing the BIA-Obesity tool involves independent civil society organisations selecting the most prominent food and beverage companies in each country, engaging with the companies to understand their policies and practices, and assessing each company's policies and practices across six domains. The domains include: "corporate strategy," "product formulation," "nutrition labelling," "product and brand promotion," "product accessibility," and "relationships with other organisations." Assessment of company policies is based on their level of transparency, comprehensiveness, and specificity, with reference to best practice.

Matched MeSH terms: Food Industry/standards*
Quality of margarine: fats selection and processing parameters

Miskandar MS, Man YC, Yusoff MS, Rahman RA

Asia Pac J Clin Nutr, 2005;14(4):387-95.
PMID: 16326646

Optimum processing conditions on palm oil-based formulations are required to produce the desired quality margarine. As oils and fats contribute to the overall property of the margarine, this paper will review the importance of beta' tending oils and fats in margarine formulation, effects of the processing parameters -- emulsion temperature, flow-rate, product temperature and pin-worker speed -- on palm oil margarines produced and their subsequent behaviour in storage. Palm oil, which contributes the beta' crystal polymorph and the best alternative to hydrogenated liquid fats, and the processing conditions can affect the margarine consistency by influencing the solid fat content (SFC) and the types of crystal polymorph formed during production as well as in storage. Palm oil, or hydrogenated palm oil and olein, in mixture with oils of beta tending, can veer the product to the beta' crystal form. However, merely having beta' crystal tending oils is not sufficient as the processing conditions are also important. The emulsion temperature had no significant effect on the consistency and polymorphic changes of the product during storage, even though differences were observed during processing. The consistency of margarine during storage was high at low emulsion flow-rates and low at high flow rates. The temperature of the scraped-surface tube-cooler is the most important parameter in margarine processing. High temperature will produce a hardened product with formation of beta-crystals during storage. The speed of the pin-worker is responsible for inducing crystallization but, at the same time, destroys the crystal agglomerates, resulting in melting.

Matched MeSH terms: Food-Processing Industry/standards*
Developments in understanding and applying prebiotics in research and practice-an ISAPP conference paper

Scott KP, Grimaldi R, Cunningham M, Sarbini SR, Wijeyesekera A, Tang MLK, et al.

J Appl Microbiol, 2020 Apr;128(4):934-949.
PMID: 31446668 DOI: 10.1111/jam.14424

AIMS: The concept of using specific dietary components to selectively modulate the gut microbiota to confer a health benefit, defined as prebiotics, originated in 1995. In 2018, a group of scientists met at the International Scientific Association for Probiotics and Prebiotics annual meeting in Singapore to discuss advances in the prebiotic field, focussing on issues affecting functionality, research methodology and geographical differences.
METHODS AND RESULTS: The discussion ranged from examining scientific literature supporting the efficacy of established prebiotics, to the prospects for establishing health benefits associated with novel compounds, isolated from different sources.
CONCLUSIONS: While many promising candidate prebiotics from across the globe have been highlighted in preliminary research, there are a limited number with both demonstrated mechanism of action and defined health benefits as required to meet the prebiotic definition. Prebiotics are part of a food industry with increasing market sales, yet there are great disparities in regulations in different countries. Identification and commercialization of new prebiotics with unique health benefits means that regulation must improve and remain up-to-date so as not to risk stifling research with potential health benefits for humans and other animals.
SIGNIFICANCE AND IMPACT OF STUDY: This summary of the workshop discussions indicates potential avenues for expanding the range of prebiotic substrates, delivery methods to enhance health benefits for the end consumer and guidance to better elucidate their activities in human studies.

Matched MeSH terms: Food Industry/standards*
Perceived safety management practices in the logistics sector

Auyong HN, Zailani S, Surienty L

Work, 2016 Mar 09;53(4):729-35.
PMID: 26967037 DOI: 10.3233/WOR-162272

BACKGROUND: Malaysia's progress on logistics has been slowed to keep pace with its growth in trade. The Government has been pressing companies to improve the safety of their activities in order to reduce society's loss due to occupational accidents and illnesses. Occupational safety and health is a crucial part of a workplace because every worker has to take care of his/her own safety and health. The main occupational safety and health (OSH) national policy in Malaysia is the enactment of the Occupational Safety and Health Act (OSHA) 1994. Only those companies which have excellent health and safety care have good quality and productive employees. This study investigated safety management practices in the logistics sector.
OBJECTIVES: The present study is concerned with the human factors to safety in the logistics industry. The authors examined the perceived safety management practices of workers in the logistics sector. The purpose was to identify the perception of safety management practices of Malaysian logistics personnel.
METHODS: Survey questionnaires were distributed to assess logistics personnel about management commitment. The quantitative method using the availability sampling method was applied. The data gathered from the survey were analysed using SPSS software. The responses to the survey were rated according to the Likert scale type, with '1' indicating strongly disagree and '5' indicating strongly agree. One hundred and three employees of logistics functions completed the survey.
RESULTS: The highest mean scores were found for fire apparatus, prioritisation of safety, and safety policy.
CONCLUSIONS: The results from this study also emphasise the importance of the management's commitment in enhancing workplace safety. Specifically, companies should maintain good relations between the employer and the employee to help reduce workplace injuries.

Matched MeSH terms: Industry/standards
Perak, Malaysia, mass poisoning. Tale of the Nine Emperor Gods and rat tail noodles

Cheng CT

Am J Forensic Med Pathol, 1992 Sep;13(3):261-3.
PMID: 1476136

In October 1988, a series of food poisoning cases occurred in the State of Perak in Malaysia. Most of the victims were children. Ultimately 13 children between the ages of 2.5 and 11 years died. Epidemiological investigations showed that the probable source of the poison was Loh See Fun, a noodles in the shape of a rat's tail. All the deceased ate the noodles from one supplier. Clinical and pathological findings were similar in each case. Postmortem examination was performed in 11 cases. Toxicological examination on organs in 10 cases showed a high concentration of aflatoxin in tissues of the deceased. High levels of boric acid were excreted from most of the victims. Histological examination of the liver in these cases showed necrotic changes found in aflatoxin poisoning. Combination of the epidemiological, clinical, toxicological, and pathological findings pointed to the fact that there was a common toxin or toxins responsible for the deaths. These were thought to be a combination of boric acid and aflatoxin.

Matched MeSH terms: Food-Processing Industry/standards
Fulltext The use of next generation sequencing for improving food safety: Translation into practice

Jagadeesan B, Gerner-Smidt P, Allard MW, Leuillet S, Winkler A, Xiao Y, et al.

Food Microbiol, 2019 Jun;79:96-115.
PMID: 30621881 DOI: 10.1016/j.fm.2018.11.005

Next Generation Sequencing (NGS) combined with powerful bioinformatic approaches are revolutionising food microbiology. Whole genome sequencing (WGS) of single isolates allows the most detailed comparison possible hitherto of individual strains. The two principle approaches for strain discrimination, single nucleotide polymorphism (SNP) analysis and genomic multi-locus sequence typing (MLST) are showing concordant results for phylogenetic clustering and are complementary to each other. Metabarcoding and metagenomics, applied to total DNA isolated from either food materials or the production environment, allows the identification of complete microbial populations. Metagenomics identifies the entire gene content and when coupled to transcriptomics or proteomics, allows the identification of functional capacity and biochemical activity of microbial populations. The focus of this review is on the recent use and future potential of NGS in food microbiology and on current challenges. Guidance is provided for new users, such as public health departments and the food industry, on the implementation of NGS and how to critically interpret results and place them in a broader context. The review aims to promote the broader application of NGS technologies within the food industry as well as highlight knowledge gaps and novel applications of NGS with the aim of driving future research and increasing food safety outputs from its wider use.

Matched MeSH terms: Food Industry/standards
Effects of two ergonomic improvements in brazing coils of air-handler units

Loo HS, Yeow PH

Appl Ergon, 2015 Nov;51:383-91.
PMID: 26154237 DOI: 10.1016/j.apergo.2015.06.007

The research aims to address the physically loading task and quality and productivity problems in the brazing of coils of air-handler units. Eight operators participated in two intervention studies conducted in a factory in Malaysia to compare the status quo brazing with (1) the use of a new twin-brazing torch that replaced the single-brazing gun and (2) brazing in a sitting position. The outcome measures are related to quality, productivity, monetary costs, body postures and symptoms. After baseline, Interventions I and II were applied for 3 months respectively. The results show a 58.9% quality improvement, 140% productivity increase and 113 times ROI. There was also a reduction in poor work postures e.g. in the raising of the arms and shoulders; bending, twisting and extending of the neck; and bending of left and right wrists, and the back. This research can be replicated in other factories that share similar processes.

Matched MeSH terms: Manufacturing Industry/standards
Fulltext Tobacco Industry Fingerprints on Delaying Implementation of Pictorial Health Warnings in the Western Pacific

Tan YL, Mackay J, Kolandai MA, Dorotheo EU

Asian Pac J Cancer Prev, 2020 Jul 01;21(S1):23-25.
PMID: 32649167 DOI: 10.31557/APJCP.2020.21.S1.23

OBJECTIVE: This case series describes tobacco industry tactics and strategies used to interfere, derail, delay, and weaken the development of effective health warning regulations in Malaysia, Cambodia, the Philippines, and Hong Kong.
METHODS: A historical review of official reports, news articles, and gray literature was undertaken to identify tobacco industry tactics and strategies to hamper government efforts in implementing stronger pictorial health warning regulations in four Asian jurisdictions (Cambodia, Hong Kong, Malaysia, and the Philippines).
RESULTS: Nineteen countries/jurisdictions in the WHO Western Pacific region currently require pictorial health warnings on cigarette packs, including some of the world's largest, in line with the WHO Framework Convention on Tobacco Control Article 11 Guidelines. In the four jurisdictions examined, tobacco industry interference consisted of lobbying and misinformation of high-level government officers and policy-makers, distributing industry-friendly legislative drafts, taking government to court, challenging government timelines for law implementation, and mobilizing third parties. Strong political leadership and strategic advocacy enabled governments to successfully overcome this industry interference.
CONCLUSION: The tobacco industry uses similar tactics in different jurisdictions to derail, delay, and weaken the implementation of effective health warning policies. Identifying and learning from international experiences can help anticipate and defeat such challenges.

Matched MeSH terms: Tobacco Industry/standards*
A study on compliance to hearing conservation programme among industries in Negeri Sembilan, Malaysia

Nor Saleha IT, Noor Hassim I

Ind Health, 2006 Oct;44(4):584-91.
PMID: 17085919

Noise is one of the hazards faced by workers. A cross-sectional study was conducted among industries in Negeri Sembilan with the objective to assess their compliance to Hearing Conservation Programme (HCP). The other objectives of this study were to determine the factors influencing it and to show the industries' compliance to each element of the programme. It was also to identify the association between compliance to HCP and the prevalence of hearing impairment and standard threshold shift. Data for this study were collected using questionnaires sent by mail and also the results of the latest audiometric tests. A total of 167 industries were analysed for this study. It was found that 41.3% of these industries fully complied to the programme. It was also found that the industries preferred to provide hearing protection device (92.8%) and least complied to noise control (61.1%). There were significant associations (p<0.05) between compliance and number of employees, status of ownership and the presence of officer in charge of hearing conservation programme. Having at least 150 employees actually raised the compliance to HCP in two folds (beta = 0.717, OR = 2.048, C.I 95% = 1.063 to 3.944). The prevalences of hearing impairment and standard threshold shift were 23.9% and 5.2% respectively. There was no significant association between the prevalence for hearing impairment and compliance to HCP. The prevalence for standard threshold shift was inversely related to compliance. This study showed that compliance percentage need to be improved as an effort to prevent the hearing problems among workers exposed to noise.

Matched MeSH terms: Industry/standards*

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