{"id":1805,"date":"2025-10-30T14:42:20","date_gmt":"2025-10-30T14:42:20","guid":{"rendered":"https:\/\/brecon.questo.nl\/?post_type=publicatie&p=1805"},"modified":"2025-11-10T09:42:22","modified_gmt":"2025-11-10T09:42:22","slug":"good-manufacturing-practice-gmp-guidelines-for-safe-and-reliable-production","status":"publish","type":"publicatie","link":"https:\/\/www.brecon.nl\/en\/publicatie\/good-manufacturing-practice-gmp-richtlijnen-voor-veilige-en-betrouwbare-productie\/","title":{"rendered":"Good Manufacturing Practice (GMP) - Guidelines for safe and reliable production"},"content":{"rendered":"

Good Manufacturing Practice (GMP) - in Dutch Goede Manier van Produceren - is the international quality system that guarantees that drugs, raw materials and preparations are safe, reliable and consistent in quality.<\/p>\n

European GMP guidelines are legally required for both human and veterinary medicines and form the basis of every pharmaceutical quality system within the EU.<\/p>\n<\/div><\/div>

<\/div>

What exactly is GMP?<\/span><\/span><\/h2>
<\/div>

GMP describes step by step how drugs should be produced, controlled and documented.<\/p>\n

Each stage - from raw material to finished product - is laid down in protocols and monitored by qualified personnel.<\/p>\n

Key components of GMP are:<\/p>\n

    \n
  • Quality assurance and documentation<\/li>\n
  • Control of raw materials and intermediate products<\/li>\n
  • Validation of equipment and processes<\/li>\n
  • Quality control and product release by a Qualified Person (QP)<\/li>\n<\/ul>\n

    GMP thus ensures that each product meets the highest quality standards and can be used safely by patients.<\/p>\n<\/div><\/div>

    <\/div>

    Supervision and GMP certification<\/span><\/span><\/h2>
    <\/div>

    In the Netherlands, GMP compliance is monitored by the Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (CBG).<\/p>\n

    After a successful inspection, the company receives an official GMP certificate, demonstrating compliance with European laws and regulations (EudraLex Volume 4).<\/p>\n

    Similar quality systems apply to other sectors, such as cosmetics and food. These are usually assessed by accredited certification bodies, but are not covered by the statutory EU GMP for pharmaceuticals.<\/p>\n<\/div><\/div>

    <\/div>

    GMP-Z: quality guideline for hospital and pharmacy preparations<\/span><\/span><\/h2>
    <\/div>

    For preparations within healthcare institutions, the separate guideline GMP-Z (Good Manufacturing Practice - Hospital Pharmacy) applies in the Netherlands. This guideline, administered by the Dutch Association of Hospital Pharmacists (NVZA), describes specific requirements for:<\/p>\n<\/div><\/div>

    <\/div>

    Good Manufacturing Practice (GMP) - Guidelines for safe and reliable production<\/span><\/span><\/h2>
    <\/div>

    Good Manufacturing Practice (GMP) - in Dutch Goede Manier van Produceren - is the international quality system that guarantees that drugs, raw materials and preparations are safe, reliable and consistent in quality.<\/p>\n

    European GMP guidelines are legally required for both human and veterinary medicines and form the basis of every pharmaceutical quality system within the EU.<\/p>\n<\/div><\/div>

    <\/div>

    What exactly is GMP?<\/span><\/span><\/h2>
    <\/div>

    GMP describes step by step how drugs should be produced, controlled and documented.<\/p>\n

    Each stage - from raw material to finished product - is laid down in protocols and monitored by qualified personnel.<\/p>\n

    Key components of GMP are:<\/p>\n

      \n
    • Quality assurance and documentation<\/li>\n
    • Control of raw materials and intermediate products<\/li>\n
    • Validation of equipment and processes<\/li>\n
    • Quality control and product release by a Qualified Person (QP)<\/li>\n<\/ul>\n

      GMP thus ensures that each product meets the highest quality standards and can be used safely by patients.<\/p>\n<\/div><\/div>

      <\/div>

      Supervision and GMP certification<\/span><\/span><\/h2>
      <\/div>

      In the Netherlands, GMP compliance is monitored by the Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (CBG).<\/p>\n

      After a successful inspection, the company receives an official GMP certificate, demonstrating compliance with European laws and regulations (EudraLex Volume 4).<\/p>\n

      Similar quality systems apply to other sectors, such as cosmetics and food. These are usually assessed by accredited certification bodies, but are not covered by the statutory EU GMP for pharmaceuticals.<\/p>\n<\/div><\/div>

      <\/div>

      GMP-Z: quality guideline for hospital and pharmacy preparations<\/span><\/span><\/h2>
      <\/div>

      For preparations within healthcare institutions, the Netherlands applies the separate guideline GMP-Z (Good Manufacturing Practice - Hospital Pharmacy).<\/p>\n

      This guideline, administered by the Dutch Association of Hospital Pharmacists (NVZA), describes specific requirements for:<\/p>\n

        \n
      • Working hygienically and aseptically<\/li>\n
      • Documentation and traceability<\/li>\n
      • Validation and quality assurance<\/li>\n<\/ul>\n

        GMP-Z is the standard for safe and controlled pharmaceutical compounding within pharmacies and hospitals.<\/p>\n<\/div><\/div>

        GMP and cleanroom requirements (ISO 14644)<\/span><\/span><\/h2>

        GMP also includes guidelines for the production areas and environmental conditions in which drugs are manufactured.<\/p>\n

        The ISO 14644 standard describes cleanroom particle cleanliness, while EU-GMP Annex 1 focuses on preventing microbiological contamination and ensuring aseptic processes.<\/p>\n

        The GMP classification (Grades A to D) is partly comparable to the ISO grades (ISO 1 to 9), but the systems differ in criteria and measurements. Both standards complement each other in the pursuit of a safe and sterile production environment Hygienic and aseptic working.<\/p>\n

          \n
        • Documentation and traceability<\/li>\n
        • Validation and quality assurance<\/li>\n<\/ul>\n

          GMP-Z is the standard for safe and controlled pharmaceutical compounding within pharmacies and hospitals.<\/p>\n<\/div><\/div>

          GMP and cleanroom requirements (ISO 14644)<\/span><\/span><\/h2>

          GMP also includes guidelines for the production areas and environmental conditions in which drugs are manufactured.<\/p>\n

          The ISO 14644 standard describes cleanroom particle cleanliness, while EU-GMP Annex 1 focuses on preventing microbiological contamination and ensuring aseptic processes.<\/p>\n

          The GMP classification (Grades A to D) is partly comparable to the ISO grades (ISO 1 to 9), but the systems differ in criteria and measurements. Both standards complement each other in the pursuit of a safe and sterile production environment.<\/p>\n<\/div><\/div>

          <\/div>\n\t
          \n\t\t
          \n\t\t\t
          \n \n \n \n \n \n \n \n \n \n
          Grade<\/th>\n At Rest
          <\/th>\n           		In Operation
          <\/th>\n <\/tr>\n\n
          Maximum permitted number of particles\/m\u00b3 equal to or above<\/th>\n <\/tr>\n\n
          0.5\u00b5m<\/th>\n 5\u00b5m<\/th>\n 0.5\u00b5m<\/th>\n 5\u00b5m<\/th>\n <\/tr>\n
          A<\/td>\n 3 520<\/td>\n 20<\/td>\n 3 520<\/td>\n 20<\/td>\n <\/tr>\n
          B<\/td>\n 3 520<\/td>\n 29<\/td>\n 352 000<\/td>\n 2 900<\/td>\n <\/tr>\n
          C<\/td>\n 352 000<\/td>\n 2 900<\/td>\n 3 520 000<\/td>\n 29 000<\/td>\n <\/tr>\n
          D<\/td>\n 3 520 000<\/td>\n 29 000<\/td>\n not defined<\/td>\n not defined<\/td>\n <\/tr>\n <\/tbody>\n <\/table>\n<\/div>\n\n