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  • WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles 2014

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    Ph.Nabil Al-Sharaf
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    This document outlines the main principles of WHO good manufacturing practices (GMP) for pharmaceutical products. It includes sections on pharmaceutical quality systems, quality risk management, product quality review, sanitation and hygiene, qualification and validation, product recalls, complaints, self-inspection and quality audits of suppliers. Specific topics covered include personnel, premises, equipment, materials, documentation, good practices in production, and good practices in quality control. The overall purpose of GMP is to ensure that pharmaceutical products are consistently produced and controlled according to quality standards to ensure they are safe, effective and meet their intended use.

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    GMP

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    This document outlines the main principles of WHO good manufacturing practices (GMP) for pharmaceutical products. It includes sections on pharmaceutical quality systems, quality risk management, product quality review, sanitation and hygiene, qualification and validation, product recalls, complaints, self-inspection and quality audits of suppliers. Specific topics covered include personnel, premises, equipment, materials, documentation, good practices in production, and good practices in quality control. The overall purpose of GMP is to ensure that pharmaceutical products are consistently produced and controlled according to quality standards to ensure they are safe, effective and meet their intended use.

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    © All Rights Reserved
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    20 views1 page

    WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles 2014

    Uploaded by

    Ph.Nabil Al-Sharaf
    This document outlines the main principles of WHO good manufacturing practices (GMP) for pharmaceutical products. It includes sections on pharmaceutical quality systems, quality risk management, product quality review, sanitation and hygiene, qualification and validation, product recalls, complaints, self-inspection and quality audits of suppliers. Specific topics covered include personnel, premises, equipment, materials, documentation, good practices in production, and good practices in quality control. The overall purpose of GMP is to ensure that pharmaceutical products are consistently produced and controlled according to quality standards to ensure they are safe, effective and meet their intended use.

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    of 1

    (GMP) ‫ﺳﻠﺴﻠﺔ اﻟﺨﺮاﺋﻂ اﻟﺬھﻨﯿﺔ‬

    ‫إﻋﺪاد ﺻﯿﺪﻻﻧﻲ‬
    ‫ﻧﺒﯿﻞ اﻟﺸﺮف‬
    WHO good manufacturing practices for pharmaceutical products: main principles 2014

    quality Risk management


    ‫إدارة اﻟﻤﺨﺎطﺮ اﻟﺠﻮدة‬
    Pharmaceutical quality system
    Good manufacturing practices for ‫ﻧﻈﺎم اﻟﺠﻮدة اﻟﺪواﺋﯿﺔ‬
    pharmaceutical products product quality review
    ‫ﻣﺮاﺟﻌﺔ ﺟﻮدة اﻟﻤﻨﺘﺞ‬
    ‫ﻣﻤﺎرﺳﺎت اﻟﺘﺼﻨﯿﻊ اﻟﺠﯿﺪة ﻟﻠﻤﻨﺘﺠﺎت اﻟﺼﯿﺪﻻﻧﯿﺔ‬

    Sanitation and hygiene


    Qualification and validation
    ‫ﻧﻈﺎم اﻟﺼﺤﺔ واﻟﻨﻈﺎﻓﺔ‬
    ‫اﻟﺘﺄھﯿﻞ وﺗﻮﺛﯿﻖ اﻟﻤﺼﺪاﻗﯿﺔ‬

    Complaints
    ‫ﺳﺤﺐ اﻟﻤﻨﺘﺞ‬Product recalls
    ‫اﻟﺸﻜﺎوى‬

    Self-inspection, quality audits and Contract production, analysis and other activities
    suppliers’ audits and approval ‫إاﻟﺘﻌﺎﻗﺪ اﻹﻧﺘﺎﺟﻲ وﺗﺤﻠﯿﻠﮭﺎ وﻏﯿﺮھﺎ ﻣﻦ اﻷﻧﺸﻄﺔ‬
    ‫اﻟﺘﻔﺘﯿﺶ اﻟﺬاﺗﻲ و ﺗﻔﺘﯿﺶ اﻟﺠﻮدة و ﺗﻔﺘﯿﺶ اﻟﻤﻮردﯾﻦ‬ good manufacturing practices
    ‫واﻟﻤﻮاﻓﻘﺔ ﻋﻠﯿﮭﺎ‬ (GMP)
    ‫ اﻟﻌﺎﻣﻠﻮن‬Personnel
    (10) ‫ اﻟﺘﺪرﯾﺐ‬Training

    (11)‫ اﻟﻨﻈﺎﻓﺔ اﻟﺸﺨﺼﯿﺔ‬Personal hygiene


    (12) ‫ اﻟﻤﺒﺎﻧﻲ‬Premises

    (13) ‫ اﻷﺟﮭﺰة‬Equipment
    (14)‫ اﻟﻤﻮاد‬Materials

    (15) ‫ اﻟﺘﻮﺛﯿﻖ‬Documentation
    (16)
    Good practices in production
    ‫اﻟﻤﻤﺎرﺳﺎت اﻟﺠﯿﺪة ﻓﻲ اﻻﻧﺘﺎج‬ (17)
    Good practices in quality control
    ‫اﻟﻤﻤﺎرﺳﺎت اﻟﺠﯿﺪة ﻓﻲ رﻗﺎﺑﺔ اﻟﺠﻮدة‬
    ph. Nabil ALsharaf

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