EN 1826-1996 en Biotechnology - Large-Scale Process and Production - Control Procedures for Raw Materials《生物工艺学 大比例方法和生产 原材料监督控制方法》.pdf

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1、STD.BSI BS EN L2b-ENGL L997 w Zb24bb9 Obbb3 32b BRITISH STANDARD Biotechnology - Large-scale process and production - Control procedures for raw materials 3 BS EN 1826 : 1997 The European Standard EN 1826 : 1996 has the status of a British Standard ICs 07.080 STD-BSI BS EN LZb-ENGL L997 Lb2LibbS ObO

2、bbLi 2b2 Amd.No. Date BS EN 1826 : 1997 Text affected This British Standard, having been prepared under the direction of the Sector Board for Materiais and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 April 1997 O ES1 1997 The following BSI referenc

3、es relate to the work on this standard Committee reference CIi58 Draft for comment 95/120896 DC ISBN O 680 26890 X Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CIV58, Biotechnology, upon which the following bodies were

4、 represented: Association of Consultants to the Bioscience Industries (Acbi) Bioindustry Association BLWA LM. (Association of the Laboratory Supply Industry) Brewing Research Foundation International British Agrochemicak Association Ltd Chemical Industries Association Confederation of British Indust

5、ry Department of Health Department of the Environment (air Climate and Toxic Directorate) Department of We and Industry (National Engineering Laboratory) Health and Safety Executive Institution of Chemical Engineers International Society for Phanneceutical Engineering Ministry of Agriculture, Fisher

6、ies and Food Public Health Laboratory Service Society for Applied Bacteriology Society for General Microbiology STD-BSI BS EN 182b-ENGL 1997 m Lb24bb ObObb5 LT = BS EN 1826 : 1997 Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN 1826 3 i STD.BSI BS E

7、N L2b-ENGL 1797 W Lb29bb7 ObIlbbBb 035 H BS EN 1826 : 1997 National foreword This British Standard has been prepared by Technical Committee CW58 and is the English language version of EN 1826 : 1996, Biotechnology - Large-scale process and production - Control procedures for raw materiaEs, published

8、 by the European Committee for Standardization (CEN). Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a Wnt cover, an inside fiont cover, pages i and ii, the EN title page, pages 2 to 8, an inside back cover and a

9、 back cover. 11 O BSI 1997 STD-BSI BS EN L2b-ENGL 1777 m Lb24bb7 ObObb7 T7L m EN 1826 September 1996 ICs 07.080 Descriptors: Biotechnology, raw materiais, definitions, storage quality, inspection English version Biotechnology - Large-sde process and production - Control procedures for raw rnakW Biot

10、echnologie - Procd grande chelle et production - Procdures de contrle pour les mres premires Biotechnik - Verfahren im GroBmai3stab und Prouktion - zur berwachung von Rohrstoffen This European Standard was approved by CEN on 19960816. CEN members are bound to comply with the CENKENELEC Interd Regula

11、tions which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-tpdate lists and bibliographical references concerning such national standards may be obtained on application to the Centrai Secretariat or to any CEN member. This Euro

12、pean Standard errists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the nat

13、ional standards bodies of Austria, Belgium, Denmark, Finland, hce, Germany, Greecem Iceland, Ireland, Italy, Luxembourg, Netherlands, Nomas Portugal, Spain, Sweden, Switzerland and United Kingdom. European Committee for Standardization Comit Europen de Normalisation Europisches Komitee l%r Normung C

14、entrai Secretariat: rue de Stassart 36, B-1060 Brussels O All rights of reproduction and communication in any form and by any means reseved in ali countries to CEN and its members. Ref. No. EN 1826 : 1996 E Foreword This European Standard has been prepared by Rchnical Committee CENmC 233, Biotechnol

15、oB, the Secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 1997, and conflicting national standards shall be withdrawn at the latest by March 1997. Accord

16、ing to the CEN/CENELEC Inted Regulations, the national standards organizations of the following countries are bound to implement this European standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Swi

17、tzerland and the United Kingdom. Contents Foreword O Introduction 1 Scope 2 Normative references 3 Definitions 4 Rawmaterialcontrol Annex A (informative) Bibliography page 3 3 3 3 3 4 7 O BSI 1997 O Introduction The use of raw materials is strongly related to quality and safety aspects to prevent po

18、tential hazxds, especially harmful microbial contaminants: - during storage; - in the process; - of the final products. The proper use of the raw - additional nutrients (e.g. minerais, vitamins); - additives, acid, base, antifoam; - aumliary materials (e.g. enzymes, lWon adjuvants); - culture media

19、for microorganisms; NOTE 2. The inoculum is not covered as a raw material in this standard. It is covered in prEN 12075 (see annex A 4). - process aiq - process steam condensed into the fermenter during sterilization by direct steam; - cldg materials. NOTE 3. Cleaning materials as weil as materials

20、used in lubrication and surface treatment of equipment should be subject to specific procedures. The specifications established by the user for raw materials should be followed by the suppliers. The receiving company should be informed in writing about any deviations. It is also recommended that com

21、plaints and rejection procedures are agreed upon by the user and the supplier. This includes verification assays. NOTE 4. Attention is drawn to national, European and international regulations concerning the control of raw material for food and pharmaceutical products. 4.2 Control procedures 4.2.1 I

22、n order to prevent potential hazards, the user should ensure the compatibility of a raw material with the production process and should ensure that no health or environmental hazard will arise during the process or as a result of its modification in the process. 4.2.2 Upon receipt the raw material s

23、hould be checked against the agreed specifications. Validated data from certified suppliers can be used. The following items should be considered, if relevant: - label description; - packagmg integrity and size; - identity of the raw material; - batch traceability (identification, origin country, ba

24、tch number and other labelling); - storage conditions; - health safety and environmental ruies related to the raw material (for material safety data sheet, see IS0 110141); - qualitative assays in agreement with standards, specifications; - distribution conditions; - limit of use. If no specific ass

25、ay exists to mure the quaiity of raw material, the quality should be verified, as appropriate, by an alternative method (e.g. by pilot experiment) to confirm conformity with 4.2.1. When a raw material is substituted, it should be proven that it is substantially equivalent to the previous one. For ra

26、w materials of biological origin with complex composition, where quaiity cannot be specified precisely, the supplier should inform the receiving company of any major changes in the production procedure, or change of sources. - purity and impurity assay agree with NOTE 1. It is recommended that conlx

27、oi procedures are in accordance with the EN IS0 9000 series (see annex A 6). NOTE 2. For medicinal products, it is recommended that good manufacturing practice (GMP) rules (see annex A 7) are also applied and the European Pharmacopoeia (see annex A SI) is used as a reference. For food products, stan

28、dards and guidelines of the Codex Alimentanus (see annex A 9) should be applied. Methods of AOAC International (Association of Officiai Analytical Chemists) (see annex A lo) or any other valid methods should be used whenever appropriate. 4.3 Verification of raw material before use 43.1 General Verif

29、ication assays, which differ from industry to industqy, to assure specifications can be as simple as a visual observation or as complicated as a simulafion of the production conditions at pilot scale. Some techniques of verification are given in 4.3.2 and 4.3.3 and should be appiied where appropriat

30、e. O BSI 1997 * r) * CERTIFICATION Page 5 EN 1826 : 1996 RECEIPT (see 4.3.2) STORAGE (see 4.4) A FI (see annex A 4) utilities (e.g. air, steam) I I Figure 1. Procedure for raw material control O BSI 1997 STD.BS1 BS EN L2b-ENGL 1997 1b24bb9 ObObb92 339 Page 6 EN 1826 : 1996 4.3.2 Veerification upon r

31、eceipt For each consignment, the containers should be checked for integrity of package and seal and for correspondence between the order, the delivery note and the suppliers labels. If specified, a quality certificate should be delivered by the supplier. Damage to containers and/or deviations of spe

32、cifications which might adversely affect the ty of a material should be documented Samples should be taken using adequate sampling procedures for anaiysis, if quick methods exist these can be performed upon receipt of the product prior to its unloadmg (in the case of bulk delivery). Depending on the

33、 result of raw material control procedures concerning step verification upon receipt in figure 1, the material will either be released for the biotechnological process or will go into quarantine. 4.3.3 Quarantine verification In order to guarantee that specifications are upheld, adequate test method

34、s (i.e. using validated procedures) should be applied to the samples taken. If on analysis the product is not within the specifications then it should be rejected Appropriate labelling and record keeping should be done in accordance with good manufacturing practice (see annex A 7) where relevant. NO

35、TE. Attention is drawn to appropriate national, European and international regulations in this regard. The release from quarantine should be done according to written procedures. These written procedures should have regard for possible deterioration of some characteristics of the raw material and th

36、e storage conditions such as the shelf life. 4.4 Storage If storage is required, accepted raw materials should be stored under appropriate conditions established by the user. AU material from the supplier or from quarantine should be checked to ensure that the consignment corresponds to the accompan

37、ying sheets or documents. Containers should be cleaned as appropriate. Raw materials in the storage area should be appropriately labelled The label should bear the name of the raw material, the intend reference code, the supplier code and safety information where applicable. NOTE. If raw materials p

38、resent a hazard, attention is drawn to the national, European and international regulations about labelling of hazardous materials. The me label or a second one should provide the following informalion which may be coded for use in a databank, where appropriate: - the status of the content (e.g. its

39、 release from quarantine); - an expiry date or a date beyond which retesting is necessa. O BSI 1997 STD=BSI BS EN LBZb-ENGL 1777 lb24bb7 ObObb73 275 Page 7 EN 1826 : 1996 Annex A (informative) Bibliography i 2 3 Council Directive 90/219/EEC of 23 Aprii 1990 on the contained use of genetically modifi

40、ed microorganisms. OJEC 08.05.1990, n“L 117 p 1. Council Directive 90/220/EEC of 23 Aprii 1990 on the deiiberate release into the environment of geneticaliy modified organisms. OJEC 08.05.1990, n“L 117 p 15. Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks rel

41、ated to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 of Directive 899UEEC). OJEC 31.12.1990, n“L 374 p 1. 4 prEN 12075 (51 prEN 12307 6 EN IS0 9000-1 Biotechnology - Large-scale process and production - Procedures for fermentation and downstrea

42、m operations Biotechno2ogy - Large-scale pmcess and production - Personnel: guidance for good pmctice, procedures, training and control Quality management and quality assurance stcLndards - Part 1: Guidines for selection and use (IS0 9001: 1994) Quality systems - Model for quality assurance in desig

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