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QM System

Sino-Ethiop Associate Africa plc operates manufacturing of empty hard gelatin capsule sunder the control of a quality management system as per the guidelines statedin the company quality policy & quality manual.The purpose of the quality policy is to ensure compliance of quality systems and procedures so that the end product meets all the required specification sensuring the quality of the products. The Quality Assurance departmentis independent from manufacturing & authorized to take appropriate decisions on quality matters of raw materials, packing materials, finished products or any other issues related to product quality. Quality is mandated and supported by top management and coordinated by Quality Assurance, which is responsibility of everyone in the plant. The Effectiveness & applicability of Quality Assurance system is regularly monitored.The Quality Assurance has a great role in the development and maintenance of   the company’s quality system. This is achieved by a combination of system aticsampling, testing, validating, monitoring and auditing of materials, facilities, systems and procedures which can influence the quality of ourproducts. Authorized and approved standard operating procedures for all operations are used. This includes, production , quality control , quality assurance, materials management, warehousing, distributing,  safety controls, housekeeping , sanitation, and engineering. Quality assurance has to ensure that these procedures areadhered and records are maintained. Anydeviation is investigated and documented .Corrective action is taken wherever necessary. Periodic self inspection and auditing are conducted to monitor theeffective implementation of the current good manufacturing practice and qualitysystem. Suppliers of major starting materials and analytical laboratory reagents are chosen according to high quality parameters and are assessed according to validatedand standardized procedures. Records generated via the implementation of the quality system are controlled and maintained according to authorized and approved procedure. Each product is subjected to appropriate types of testing and control according tothe specifications approved by the registration authorities and the redefined quality parameters. Records generated from the whole processes concerned with the production of the product are well revised and checked before the releaseof the product .Stability evaluation according to pre-defined protocol to meet ICH guidelines and market needs is an essential requirement for our products.

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T (251) 1 4450035/4450063

Debrezeit Road, Gelan, Addis Ababa

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