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Personnel
SANA Pharma is running by a group of qualified technical people who have excellent experience in product development, analysis and regulatory aspects related to pharmaceutical industry world wide.
| Samer M. Najjar, (General Manager) |
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» M.Sc. Pharmaceutical technology.
» 15 years of experience in pharmaceutical research.
» R&D and technical manager at Joswe medical (Fast growing generic company in Jordan) for the past of 8 years, with successful development of wide range of challenging products including advanced delivery systems.
» Excellent knowledge and experience of analytical methods development, validation, Preformulation, stability testing, and scaling up of products.
» Excellent knowledge and experience of regulatory filing including CTD dossiers preparation and response to regulatory inquiries.
» Excellent knowledge of IPR issues related to formulation and registration processes.
» Excellent knowledge of pharmacokinetics related to drug development and conduction of bioequivalence studies, with solid experience in monitoring and auditing of bioequivalence studies and biocenters.
» Excellent experience in cGMP and site inspection.
» Active in many areas of pharmaceutical research with five published articles and many articles/patent under publications.
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| Raed M. Salah, (Technical Manager) |
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» Modular M.Sc. (Pharmaceutical Industry Advanced Training), Manchester, UK.
» 16 years of experience in pharmaceutical, Veterinary and Cosmetic industries
» R&D /QA/QC Senior Consultant.
» Excellent experience in GMP regulation and implementation.
» Certified Project management professional (PMP) from Project Management Institute (PMI).
» Participated in establishing and upgrading QA/QC systems for many pharmaceutical manufacturing companies in Syria, Singapore, and Jordan.
» Successfully completed registration and development of wide range of Human and Veterinary pharmaceutical products especially in liquids, semisolids and sterile dosage forms.
» Successfully completed registration and development of standardized herbal medicine of challenging formulation and analytical methods.
» Developed & delivered GMP training courses, including auditing practice, to many of pharmaceutical companies.
» Active in many of professional bodies including (International Society of Pharmaceutical Engineers, Project Management Institute, Pharmaceutical Quality Group).
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| Hassan I. Jelekh, (Bussiness Development Manager) |
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» MBA (executive masters in enterprise management), Durham Business school, UK .
» Bsc. Pharmacy, university of Jordan.
» 14 years of experience in pharmaceutical sales and marketing.
» worked for local and multinational pharmaceutical firms.
» specialized in product life cycle and pipeline management.
» Experience in marketing generic and under-license products.
» work experience in all of the countries of the Middle East and North African (MENA)region.
» Successfully supervised and managed launches of pharmaceutical products in the MENA region.
» diversified managerial positions spanning sales, marketing, regulatory affairs, and business development.
» participated in establishing and deployment of pharmacovigilance system.
» Member in the CMI of UK
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| Ibraheem Rajab (QA/QC Manager) |
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» B.Sc. Chemistry, University of Jordan
» Member of Royal Society of Chemistry – Cambridge - UK
» Member of Jordanian Chemical Society
» 8 years experience in the pharmaceutical industry (R&D, QC and QA):
» Pharmaceutical Regulations:
- Worked under variety of regulated environments: FDA Approved, European GMP Certified, Japanese Corporation and (MENA) Middle East and North Africa.
- Very good commands with: (Pharmacopias: BP, EP, JP and USP), cGMP, GLP, ICH, FDA, ISO9000 (ISO 17025:2005) requirements.
» Laboratory
- Qualification and Analytical Chemical Methodology Transfer Protocols.
- Planning of the analytical activities in the chemical laboratory on daily basis.
- Instruments Qualification, Calibrations and troubleshooting.
» Analytical and Instrumentation Skills:
- Drugs Products: In process and Release Analysis. Stability “Long term, Accelerated and On-going” and Reserve Samples Schedules, Testing, Results and Summaries.
- Drugs compounds Chemical Analysis.
- Cleaning Validation and Verification analysis and documentation.
- Validating & Developing of Analytical and Testing methods: for Raw Materials and Finished Products.
- Pre-formulation survey, research and analysis regarding materials interactions.
- HPLC “UV, PDA, chemical and RI detectors”, IR, UV, AA. Analysis of Purified Water and full physical testing and Wet chemistry, all at professional Level.
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Site
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SANA Pharma has a site of total area of 600 square meters. It includes the followings:
- Pilot scale manufacturing site
- Wet lab
- Balance room
- Instrumental lab
- Chromatography lab
- Stability room
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Instruments and equipments
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SANA Pharma is equipped with qualified instruments for testing of all dosage forms. The lab is equipped many advanced HPLC systems (PDA, gradient, with cooling & heating options for column and auto sampler). In addition to spectrophotometers, particle size analyzer (microscope with camera), dissolution systems, disintegration, friability, and hardness testers, moisture analyzer, Karl- Fischer apparatus, and accurate analytical balances. All instruments at SANA Pharma are subjected to scheduled calibration program according to SANA quality system.
The lab-scale area for solid dosage forms is equipped with advanced drive motor with various attachments for all pharmaceutical operation linked to the motor through universal gear. The lab is also equipped with liquid mixing / homogenizing machines for preparation of liquid dosage forms.
SANA pilot area is prepared with pilot scale machineries that include:
� Rapid shear mixer granulator (GMP model)
� Rotary, 8 � station tablet press with force feeding and pre -compression feeding options
� Semi � automatic Blistering machine. |


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