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DRUG RESEARCH & DEVELOPMENT CENTER
SIGMA GROUP
   
Overview
 

Fast growth of Sigma pharmaceutical Group is putting a drastic challenge to secure new products continuously for all member companies to face the drastic Competition in the relevant markets.

One of the important factors in the pharmaceutical market is the QUALITY which is built in the product from the beginning  starting from the stage of the development. Another influencing factor in market competition is getting the products to the market FASTER to create competition advantages over other companies and saves money with globalization, the local markets-on the long run- are expected to dissolve gradually in the global one and competition in the markets is escalating.

Furthermore, with the application of the TRIPS agreement of protecting pharmaceutical chemicals, it is safer for Sigma to have its own protected products, through innovative research to overcome possible limitations in generic business.

 

To cope with this situation, it was necessary for Sigma Group to have a well designed, well equipped, highly scientific Center for Research and Development for the following reasons:

  • About 700 products for Sigma and SigmaTec are under different stages of registration which requires completely dedicated tool to carry out the required work for this large number of products.
  • This number is expected to be increased through the continuous introduction of new products for registration. In addition to the products required for abroad companies of Sigma.
  • The pooling of major R&D activities in one center facilitates the design and implementation of clear R&D policy. Furthermore, prevents duplication of expensive machines and instruments and facilitates maintenance as well as supervision, training of personnel and creation of scientific environment. 
  • The adopted location of the R&D center in the vicinity of Cairo facilitates the contacts and connections with supervisors, research bodies and universities. 
 

About Us    

R&D center of Sigma Group is directly reporting to the Chairman and Managing Director of Sigma Pharmaceutical Group. The R&D Center is located in the laboratories building at the SigmaTec. Compound, 6th Oct. City, Cairo-Egypt on a total area of about 1380Sq. m. To meet rapid expansion, a new independent building will be added to the recent building of total areas of 2000Sq.M on a foot print area of 500Sq. M.

The center consists of four departments including, Research, Products Developments (Formulation), Methodology, Stability Testing and Packaging Materials Development. The R&D center has a professional staff of 40 persons including high caliber researchers of pharmacists, chemists, Data entry, technician and secretary.

The Center is equipped with highly advanced instruments, and the necessary software required for the research and development of products, methods of analysis and stability tastings. 

   

Vision

  • To be one of the most productive and reputable research and development bodies in the pharmaceutical industry in Egypt and the surrounding area.

Mission

  • To improve health through innovation and/or development of high quality, safe And effective pharmaceutical products. 
  • To become a principal motor of sustaining growth and profitability of Sigma Incorporation.

Policy

The concept of R&D policy relies on the following principles:
  • No research for research, but the research should be oriented to the needs and benefit of the incorporation according to well defined priorities. 
  • The path of requests and interrelationship between the R&D center and companies of the incorporation should be well defined. 
  • Be ambitious but cautious in going to advanced innovative research but keeping in mind the target of moving Sigma Inc. from brand generic into research incorporation. 

Goals

  • To establish, develop and maintain a state of art R&D center with high out- put capacity to meet the rapid expansion and needs of Sigma Inc. to be- gradually converted into a research incorporation. 
  • To create a scientific atmosphere coupled with professional skills to produce an  outstanding pattern in R&D activities.  
  • To continuously enhance the performance of R&D personnel through training and scientific contacts.
  • Design and implement rigorous quality assurance system starting from day one. 
  • Keeping dynamic contacts with the member companies to achieve assignments and contribution in dealing with troubleshooting in due time. 
  • High performance in  achieving the usual PDL activities including development of new formulations of dosage forms, analytical methodology ,setting specifications, art design and stability studies. 
  • To assess developments and advances world wide with a view of licensing or baying in the technologies at an early date and to assimilate and improve upon them for the commercial production. 
  • Continual development and updating of the R&D center in terms of introducing new applications e.g. new drug delivery system or new technologies. 
  • To be  involved in wide range  of activities in looking for  new products and/or dosage forms, new ideas or proposals to enhance Sigma product's quality and carrying scientific searching  to support decision making process. 
  • To organize, manage and monitor different R&D projects at different stages of trials, with continuous assessment of out come to reach the proper decisions; to go on or to stop.    
 

Activities

 Pharmaceutical Products Development (PDL Dept.)
The aim of pharmaceutical product development is to design a high quality product and its manufacturing process. Aspects of drug substances, Excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified. Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can have impact on the quality of the drug product.

 

Procedures:

  • Pre-formulation Phase
    • Study of Active ingredient
    • Study of Other ingredients (Excipients)
    • Study of primary packaging material  
    • Formula design 
  • Formulation Phase 
  • Process Development & scaling up (Development Batch)
    • Design
    • Challenging of critical process parameters (Risk analysis)
    • Laboratory scaling up & Process Verification
    • Setting of quality plan

Analytical Method Development (Methodology Dept.)

Methodology Department deals with, develop and validate the method of analysis to guarantee its accuracy, reliability that reveals even minor deviations in the product and verifying their suitability under actual condition of use and also deals with optimization of the analytical method through method transfer to apply it routinely in Q.C labs and ensures that changes in the composition of the drug product adversely affect the analytical procedure through re-validation. The main activities include: 

  • Analytical method Development (stability indicating)
  • Analytical test method validation
  • Research and development monitoring 
  • Analytical method transfer
  • Primary production batch monitoring
  • Method Evaluation and Method Re-validation (Change control)

 

Stability Studies (Stability Testing Dept.) 

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions . The main activities include:

  • Stability study on R&D batches & batch monitoring.
  • Accelerated & Long Term stability study for registration purposes
  • Stability studies (Accelerated, Long Term& or In-use) for primary batches.
  • Follow up stability studies (On-going &post-marketing)
  • Stability Studies for exportation according to the relevant country regulation.

  

Research Department

  • The research department is assigned to contribute effectively in solving the difficult problems facing product design & stability problems.
  • Research department will be involved in more sophisticated issues including development of new drug delivery systems, Biological & Biotechnology products, Neutraceuticals in addition to analytical research.
  • Use of new technologies as Nanotechnology in innovation & development of Sigma Group products.
  • Introduction of products derived from natural sources.
  • Searching through its drug information facilities is one of the main tools in scientific searching for new drugs, molecules, and new trends, innovations, regulations and guidelines in the global pharmaceutical industries

 

Packaging Materials Development (PMD Dept.) 

  • PMD aim is to create high quality printed packaging materials with complete precise scientific data with regards to local and foreign regulatory authority requirements.
  • Guided by Sigma group standards and policy, PMD constantly work to fulfill customer satisfaction and to exceed their expectations.

Responsibilities of PMD include:
  • Preparing leaflets in both Arabic and English languages according to the approved scientific references 
  • Designing of packaging materials (boxes, labels..etc). 
  • Preparing the printed data on ampoules and prefilled syringes. 
  • Establishing coding system (code numbers and barcodes) for all products. 
  • Revising and approving the printing press proofs. 
  • Following up the packaging material in the printing press.
     

 
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