General Department of Quality |
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Regulatory Affairs Department
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Research & Development Department
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Validation Department
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Quality Assurance Department
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Quality Control Department
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Microbiology Department
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Stability Department
GMP & ISO Certificates
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Our company
has implied and expressed theme of quality. This is approved in the
slogan “Quality First”. Amoun pharmaceutical company is accredited
with several certificates as the first pharmaceutical company in
Egypt:
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ISO 9001 (Quality Management System) in April 1996.
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ISO 14001 (Environmental Management System) in May 1997.
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BS-7799 (Information Security Management system) in April 2002.
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OHSAS-18001 (occupational Health & Safety System) in May 2000.
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UNIDO (Innovative Enterprises in Africa) in 1997.
Function of each department
Regulatory Affairs Department:
“Backbone of operation” |
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No Sales without registration.
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Registration / Pricing
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Obtaining Licenses For
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Manufacturing Plant
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Warehouses
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Scientific Offices
- Obtaining MOH Releases for
- Imported Materials
- Amoun Products Commercial Batches
Research & Development Department: (Pick a Slogan
Also For This Like For Registration)
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Development, formulation and method of analysis of products
under development.
- Preparing a Drug Master File.
- Scaling-up of the manufacturing process to mass production.
Validation Department: (Pick a Slogan
Also For This Like For Registration)
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Creating and executing of validation programs,
procedures and protocols.
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Following up on different validation activities.
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Develop and maintain validation master plan for facilities,
manufacturing process and equipment.
Quality Assurance Department (Pick a Slogan Also
For This Like For Registration) |
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Ensure the establishment of c GMP rules in
the factory.
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Establishing Quality management system through ISO 9001.
- Complying of the finished product to spices??? to the
required specifications from the moment of receiving the
raw materials or packing materials in the warehouse till
the entrance of finished product to the warehouse Follow
up the establishing of cGMP rules to the warehouse &
production to cover all the steps of manufacturing the
drug.
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Quality Control Department
(Pick a Slogan Also For This Like For Registration)
- Identification, test of purity & assay of coming raw materials & primary packaging materials either from local market or imported goods
- Physical & Chemical analysis of intermediate & finished
products
- In-process control during batch assembly
- Daily analysis of purified water & water for injection
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