Nidda Arshad Rohaila

 Research Proposal on 'Pharmaceutical packaging': A review of current packaging materials for oral solid dosage in compliance with Marketing Authorization & GMP Requirement Student’s name: Christiana Supervisor: Prof. Berkley John Class Number: 123 Date: 23rd December, 2016 Oxford University 'Pharmaceutical packaging': A review of current packaging materials for oral solid dosage in compliance with Marketing Authorization & GMP Requirement Introduction Packaging is the economical way of protecting the product from environment, presenting, identifying, and enabling accurate dosage of medicine, storage, prevention from all environmental and physical hazards, and providing all the necessary information about pharmaceutical products from manufacturing till its final consumption (Zadbuke et al., 2013; Mills, 2010). To ensure the highest standards of quality and safety of the health products, many national and international organizations and institutions issue directives (known as Good Manufacturing Products) in collaboration with pharmaceutical industry (Reis et al., 2015). For marketing of particular medicinal products, a scientific assessment is carried out to ensure if the product is acceptable for human use and healthcare professionals. Objective of research The main objective of this research is to conduct a review of current packaging materials for oral solid dosage i.e. if the materials used for packaging the pharmaceutical products is in compliance with Marketing Authorization & GMP requirements. The pharmaceutical packaging trends of six companies will be used for the purpose of conducting this research. Of these six companies, five are selected from among top ten universities while the sixth company is the one in which the researcher is currently employed. Background The oral dosage forms of medicines are different forms by which drug molecules are delivered to the particular site in the body where the action is required (Qiu, Chen and Zhang, 2009). Different types of oral dosage forms include tablets, capsules, pellets, pills, troches, lozenges etc. All of these forms of oral solid dosage are packaged using different materials including cardboard, paper, glass, plastic, metal and rubber. The medicinal products are those which are closely related to the health of human being so they must be according to the guidelines issued by the World Health Organization (WHO), European Medicine Agency, US food and Drug Administration (FDA), and Pharmaceutical Inspection Co-operation for ensuring the quality and safety of products (Kunal, Akhilesh and Kumar, 2012). The recent pharmaceutical packaging technologies include blow-fill seal technology, anti-counterfeit packaging technologies, Radio frequency identification (RFID) technology (Pareek and Khunteta, 2014). All the pharmaceutical companies around the globe are required to follow the guidelines set by Good Manufacturing Products (GMPs) and they must have marketing authorization to promote and sell their products to patients and healthcare professionals (Reis et al., 2015). Research Methodology This is a purely qualitative research in which I will analyze the recent packaging trends used by the pharmaceutical industry. I will use secondary data collection method for the purpose of conducting this research. The population of this research study is the entire pharmaceutical companies of the world. The sample of this research include six pharmaceutical companies, of these six companies, five are selected from among top ten universities while the sixth company is the one in which the researcher is currently employed (Topforeignstocks.com, 2016). These companies include Pfizer, Novartis, Merck, GlaxoSmithKline, and Abbott and TEVA is the workplace of the researcher. I will use the websites, reports of these companies, and previous researched for the purpose of data collection and the data will be use to gain the in-depth analysis of packaging materials used by these companies. The data obtained for TEVA will be collected by first-hand experience. Research Question The research question of this research is as follows “Does the current packaging materials for oral solid dosage produced by these companies comply with Marketing Authorization & GMP Requirement?” Expected findings All of the six pharmaceutical companies use sustainable packaging guidelines for ensuring the quality and safety of the products and reducing the environmental footprints. The companies are allowed to issue their products for human use if they comply with the marketing authorization guidelines. Conclusion The packaging of pharmaceutical products is a very sensitive issue because it is related to the health and safety of human beings. Packaging ensures the protection and proper dosage of medicines so it must follow the Marketing Authorization and GMP requirements. The companies issuing the medicines and drugs ensure their sustainable packaging to promote the health of consumers. REFERENCES Conway, B. (2010). Solid Dosage Forms. In: Pharmaceutical Sciences Encyclopedia, 1st ed. Ohn Wiley & Sons. Hc-sc.gc.ca. (2016). Marketing Authorizations - Acts and Regulations - Food and Nutrition - Health Canada. [online] Available at: http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/ma-amm-eng.php [Accessed 23 Dec. 2016]. Kunal, M., Akhilesh, D. and Kumar, B. (2012). Recent Trends in Pharmaceutical Packaging: A Review. INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES, 1(3), pp-. Mills, S. (2010). Pharmaceutical packaging – an overview including some considerations for paediatrics. Training workshop: Pharmaceutical development with focus on paediatric formulations. Beijing. Pareek, V. and Khunteta, A. (2014). PHARMACEUTICAL PACKAGING: CURRENT TRENDS AND FUTURE. International Journal of Pharmacy and Pharmaceutical Sciences, 6(6). Qiu, Y., Chen, Y. and Zhang, G. (2009). Developing solid oral dosage forms. 1st ed. Amsterdam: Academic Press. Reis, C., Gouveia, B., Rijo, P. and Gonçalo, T. (2015). Good manufacturing practices for medicinal products for human use. Journal of Pharmacy and Bioallied Sciences, 7(2), p.87. Teja, I., Gupta, N., Biswas, S., Gangadharappa, H., Kumar, T. and Kumar, M. (2011). Compilation of key GMP requirements in India and EU for tablet manufacturing companies. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES, 11(16). Topforeignstocks.com. (2016). The Top 50 Global Pharma Companies 2013 | TopForeignStocks.com. [online] Available at: http://topforeignstocks.com/2013/05/25/the-top-50-global-pharma-companies-2013/ [Accessed 22 Dec. 2016]. Zadbuke, N., Shahi, S., Gulecha, B., Padalkar, A. and Thube, M. (2013). Recent trends and future of pharmaceutical packaging technology. Journal of Pharmacy and Bioallied Sciences, 5(2), p.98.