EN 1826:1996
(Main)Biotechnology - Large-scale process and production - Control procedures for raw materials
Biotechnology - Large-scale process and production - Control procedures for raw materials
This European standard gives guidance on control procedures for raw materials u used in the biotechnological processes. This European standard does not list individual materials, but provides criteria against which raw materials used in industrial biotechnology processes can be checked. This European standard is applicable to all materials used during production of products by means of a biotechnological process. It is not applicable to equipment.
Biotechnik - Verfahren im Großmaßstab und Produktion - Verfahren zur Überwachung von Rohstoffen
Diese europäische Norm gibt eine Anleitung zur Überwachung von Rohstoffen, die in biotechnischen Verfahren verwendet werden. Diese europäische Norm führt nicht einzelne Stoffe auf, sonden beinhaltet Kriterien, nach denen die in der industriellen Biotechnik eingesetzen Rohstoffe überwacht werden können.Diese europäische Norm ist für alle Stoffe anwendbar, die bei der Herstellung von Produkten mit Hilfe biotechnischer Verfahren eingesetzt werden. Sie ist nicht für Geräte und Ausrüstungen anwendbar.
Biotechnologie - Procédé à grande échelle et production - Procédures de contrôle pour les matières premières
Cette norme européenne établit des lignes directrices pour les procédures de contrôle des matières premières utilisées dans des procédés biotechnologiques. La présente norme ne fait pas l'inventaire des matières une par une mais fournit des critères à partir desquels les matières premières utilisées dans des procédés biotechnologiques industriels peuvent être contrôlées. Cette norme européenne s'applique à toutes les matières utilisées au cours de la production de produits obtenus par un procédé biotechnologique. Elle ne s'applique pas aux équipements.
Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Postopki kontrole vhodnih materialov
General Information
- Status
- Published
- Publication Date
- 17-Sep-1996
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 2 - Large-scale process and production
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 1826:1996 is a European Committee for Standardization (CEN) standard titled Biotechnology - Large‑scale process and production - Control procedures for raw materials. It gives guidance and criteria for assessing raw materials used in industrial biotechnology processes. The standard does not list specific materials and is not applicable to equipment. EN 1826 is intended to support consistent, auditable control of inputs to biotechnological production and was adopted by national bodies (e.g., SIST EN 1826:1999).
Key topics and requirements
EN 1826 provides a framework of control procedures and criteria for raw material management in bioprocessing. Key topics typically covered in the guidance include:
- Raw material specifications and acceptance criteria - establishing attributes and limits against which incoming materials are checked.
- Sampling and testing principles - guidance on representative sampling and analytical checks appropriate for large‑scale processes.
- Supplier qualification and documentation - criteria for assessing and recording supplier capability, certificates of analysis, and material provenance.
- Traceability and record keeping - requirements for linking materials to batches and production records to support investigation and recall.
- Storage, handling and contamination control - measures to protect material quality between receipt and use.
- Non‑conformance management - procedures for rejection, quarantine and disposition of materials that fail checks.
Note: The standard sets out criteria and procedural guidance rather than prescribing exact test methods or a list of raw materials.
Applications
EN 1826 is practical for organizations involved in industrial‑scale biotechnology where control of input materials affects product quality, yield and regulatory compliance. Typical users include:
- Biotechnology and biopharmaceutical manufacturers scaling up production
- Quality assurance and quality control teams defining raw material control plans
- Procurement and supplier management groups assessing vendor qualification
- Process engineers and production managers implementing large‑scale bioprocesses
- Auditors and regulators reviewing procedural compliance and traceability
Using EN 1826 supports robust raw material quality management, reduces supply‑chain risk, and aligns internal procedures with European best practice for bioprocess inputs.
Related standards
EN 1826 is commonly used in conjunction with broader quality and regulatory frameworks such as ISO quality management standards, sector Good Manufacturing Practices (GMP) guidance, and other biotechnology‑specific standards that address testing methods, production controls and documentation. These complementary references help translate the EN 1826 criteria into operational procedures and analytical methods.
Keywords: EN 1826, biotechnology, raw materials control, large‑scale production, CEN standard, bioprocessing, supplier qualification, traceability.
Frequently Asked Questions
EN 1826:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - Control procedures for raw materials". This standard covers: This European standard gives guidance on control procedures for raw materials u used in the biotechnological processes. This European standard does not list individual materials, but provides criteria against which raw materials used in industrial biotechnology processes can be checked. This European standard is applicable to all materials used during production of products by means of a biotechnological process. It is not applicable to equipment.
This European standard gives guidance on control procedures for raw materials u used in the biotechnological processes. This European standard does not list individual materials, but provides criteria against which raw materials used in industrial biotechnology processes can be checked. This European standard is applicable to all materials used during production of products by means of a biotechnological process. It is not applicable to equipment.
EN 1826:1996 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1826:1996 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Postopki kontrole vhodnih materialovBiotechnik - Verfahren im Großmaßstab und Produktion - Verfahren zur Überwachung von RohstoffenBiotechnologie - Procédé a grande échelle et production - Procédures de contrôle pour les matieres premieresBiotechnology - Large-scale process and production - Control proce
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