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The Research and Development (R&D) department are responsible for the research and development of pharmaceutical and supplement products at Hi Pharm. This process involves the build-up of a comprehensive research database on each drug product, the development of formulas and manufacturing processes, defining the specifications of the finished products and the development of analytical methods for quality assessment of these finished products.
At Hi Pharm, the R&D department applies cGMP, GLP, and GDP along with ISO 9001:2015 throughout the entire research and development process. The R&D department is compliant with the guidelines set forth in the Quality, Environmental, Health, and Safety Policy at Hi Pharm. Additionally, the R&D department has set forth additional specific guidelines for the handling of operations in the R&D department.
At Hi Pharm, the Research and Development Department is divided into 4 sections:
The R&D Formulation Section is responsible for the development of generic formulas and manufacturing processes of all Hi Pharm’s Products. The process begins with the conduction of comprehensive research on the active ingredient and the reference product to determine the critical factors that affect the drug’s performance. Based on this research, generic formulas are developed and small-scale trials are prepared and tested in the R&D Laboratory to assess the efficacy, quality, and stability of the developed formula. Successful formulas are then evaluated for large-scale production and a detailed manufacturing process is developed and transferred to the production department.
The R&D Methodology Section is responsible for the development and validation of all analytical methods used for the quality control of Hi Pharm’s Products. Firstly, comprehensive research is carried out on the active ingredient to determine its physicochemical properties and to identify suitable analytical techniques that can be used for its determination. Analytical methods can either be compendial (originating from one of the official pharmacopeias e.g. United States Pharmacopeia, British pharmacopeia, ..etc.) or non-compendial (developed in-house through methodology trials). Afterward, the analytical methods are validated according to the ICH Quality Standards to ensure that the analytical methods are suitable for their intended purpose. Finally, validated analytical methods are issued and transferred to the Quality Control department.
According to the Egyptian Drug Authority’s regulations, all generic products must be similar to the reference products in terms of quality and efficacy. The similarity of generic products and reference products can be established by either a Bioequivalence or a Biowaiver Study. The R&D Comparative Section is responsible for overseeing of all Bioequivalence or Biowaiver studies conducted on Hi Pharm’s products. Bioequivalence studies involve the testing of both products on healthy volunteers to assess their efficacy, quality, and safety. These studies are conducted externally at specialized Bioequivalence Centers and are overseen by the R&D Comparative Section. On the other hand, Biowaiver Studies involve in-vitro comparison of the release profiles of both products in different dissolution mediums. These studies may be conducted externally at Bioequivalence Centers or internally in-house by the R&D Comparative Section.
The R&D Documentation Section oversees the build-up of a complete database on all of Hi Pharm’s products. This database typically includes all research data, formulation and methodology technical documents, product history, and regulatory status. This section also assists in the preparation of the technical files used for registration of the re-registration of Hi Pharm’s Products.
Currently, the R&D department is developing new generic drug products that can be used for contraception and the treatment of breast cancer. Additionally, the R&D department are expanding Hi Pharm’s portfolio of supplement products by developing new products that meet the Egyptian market’s needs.
14 August 2021
It was first only an idea from one of our experienced and dedicated warehouse employees, to change collecting boxes and shipping boxes sizes of our Ear drops products, in order to maximize shipping space and saving costs. Logistics & Warehouse team began to execute such good idea, and upon finalization, it worked and saved 22%…
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