1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1826 : 1997 The Eur
2、opean Standard EN 1826 : 1996 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Large-scale process and production Control procedures for raw materialsBS EN 1826 : 1997 This British Standard, having been prepared unde
3、r the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 April 1997 BSI 1997 The following BSI references relate to the work on this standard: Committee reference CII/58 Draft for comment 95/120896 DC ISBN 0
4、 580 26890 X Amendments issued since publication Amd. No. Date Text affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CII/58, Biotechnology, upon which the following bodies were represented: Association of Consulta
5、nts to the Bioscience Industries (Acbi) Bioindustry Association BLWA Ltd. (Association of the Laboratory Supply Industry) Brewing Research Foundation International British Agrochemicals Association Ltd. Chemical Industries Association Confederation of British Industry Department of Health Department
6、 of the Environment (air Climate and Toxic Directorate) Department of Trafe and Industry (National Engineering Laboratory) Health and Safety Executive Institution of Chemical Engineers International Society for Pharmeceutical Engineering Ministry of Agriculture, Fisheries and Food Public Health Labo
7、ratory Service Society for Applied Bacteriology Society for General MicrobiologyBS EN 1826 : 1997 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN 1826 3ii BSI 1997 BS EN 1826 : 1997 National foreword This British Standard has been prepared by Tech
8、nical Committee CII/58 and is the English language version of EN 1826 : 1996, Biotechnology Large-scale process and production Control procedures for raw materials, published by the European Committee for Standardization (CEN). Compliance with a British Standard does not of itself confer immunity fr
9、om legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 8, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung
10、Central Secretariat: rue de Stassart 36, B-1050 Brussels All rights of reproduction and communication in any form and by any means reseved in all countries to CEN and its members. Ref. No. EN 1826 : 1996 E EUROPEAN STANDARD EN 1826 NORME EUROPE ENNE EUROPA ISCHE NORM September 1996 ICS 07.080 Descri
11、ptors: Biotechnology, raw materials, definitions, storage quality, inspection English version Biotechnology Large-scale process and production Control procedures for raw materials Biotechnologie Proce de a grande e chelle et production Proce dures de contro le pour les matie res premie res Biotechni
12、k Verfahren im Gromastab und Produktion zur U berwachung von Rohrstoffen This European Standard was approved by CEN on 1996-08-16. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stand
13、ard without any alteration. Up-tp-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other la
14、nguage 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 national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greecem Iceland, Irela
15、nd, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1826 : 1996 BSI 1997 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the Secretariat of which is held by AFNOR. This European Standard sha
16、ll 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. According to the CEN/CENELEC Internal Regulations, the national standards organ
17、izations 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, Switzerland and the United Kingdom. Contents Page Foreword 3 0 Introducti
18、on 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Raw material control 4 Annex A (informative) Bibliography 7Page 3 EN 1826 : 1996 BSI 1997 0 Introduction The use of raw materials is strongly related to quality and safety aspects to prevent potential hazards, especially harmful microbial con
19、taminants: during storage; in the process; of the final products. The proper use of the raw materials is determined by these aspects. The intrinsic properties of the raw materials should be taken into consideration and a generalization of these aspects is not possible. At any time when a raw materia
20、l is introduced or changed, a list of specifications and verification assays should be created to guarantee the quality of the end-product and to limit risk for human health, safety and environment. 1 Scope This European Standard gives guidance on control procedures for raw materials used in biotech
21、nological 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 biotechn
22、ological process. It is not applicable to equipment. NOTE. Use of raw materials is covered in the European Standard Procedures for fermentation and downstream operations (see annex A 4). 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other p
23、ublications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or rev
24、ision. For undated references the latest edition of the publication referred to applies. ISO 11014-1 Safety data sheet for chemical production Part 1: Content and order of sections 3 Definitions For the purposes of this standard, the following definitions apply: 3.1 process Totality of unit operatio
25、ns involved in the production of a defined product and of waste. 3.2 quarantine Isolation of materials by physical or other effective means whilst awaiting a decision on their release or rejection. 3.3 raw material Material used during production of products by means of a biotechnological process. 3
26、.4 raw material control Procedures for assuring the acceptability of raw materials used in the biotechnological process. 3.5 specification Document stating requirements. NOTE 1. A qualifier should be used to indicate the type of specification, such as product specification, test specification. NOTE
27、2. A specification should refer to or include drawings, patterns or other relevant documents and indicate the means and the criteria whereby conformity can be checked ISO 8402. 3.6 supplier Party that is responsible for the product, process or service and is able to ensure that quality assurance is
28、exercised. NOTE 1. The definition may apply to manufacturers, distributors, importers, assemblers and service organizations EN 45020. NOTE 2. The term product defined in EN 45020 is understood as raw material. NOTE 3. The supplier is in general a different party from the user. However, users can, in
29、 certain cases, be their own suppliers of equipment and materials, for example utilities. 3.7 user Manufacturer responsible for the biotechnological process who uses equipment and materials as input. 3.8 validation record Proof relying on documentary evidence. 3.9 verification assay Assay used to de
30、termine whether the material meets the specifications.Page 4 EN 1826 : 1996 BSI 1997 4 Raw material control 4.1 General The purchase of raw materials should involve personnel who have experience or knowledge of the product and suppliers. A list should be established that guarantees control of the pr
31、operties and the handling of the raw materials before use in and during the process. Figure 1 shows the procedure for raw material control. NOTE 1. Attention is drawn to the protective measures for workers to be applied, where appropriate, when handling raw materials (see annex A 5). The relevance o
32、f every point on the list should be decided on a case by case basis dependent on the application and the use of the finished product. The control procedures for each raw material used for each process should be established and followed. It is recommended that a validation record is kept by documenti
33、ng all important facts concerning the raw materials. Amongst the raw materials that should be taken into consideration are the following: water; carbon and nitrogen sources; additional nutrients (e.g. minerals, vitamins); additives, acid, base, antifoam; auxiliary materials (e.g. enzymes, filtration
34、 adjuvants); culture media 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 air; process steam condensed into the fermenter during sterilization by direct steam; cleaning materials. NOTE 3. Cleaning mater
35、ials as well as materials 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
36、 also recommended that complaints 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
37、Control procedures 4.2.1 In 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
38、receipt the raw material should be checked against the agreed specifications. Validated data from certified suppliers can be used. The following items should be considered, if relevant: label description; packaging integrity and size; identity of the raw material; batch traceability (identification,
39、 origin country, batch number and other labelling); storage conditions; health safety and environmental rules related to the raw material (for material safety data sheet, see ISO 11014-1); qualitative assays in agreement with standards; purity and impurity assays agree with specifications; distribut
40、ion conditions; limit of use. If no specific assay exists to assure the quality 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 su
41、bstantially equivalent to the previous one. For raw materials of biological origin with complex composition, where quality cannot be specified precisely, the supplier should inform the receiving company of any major changes in the production procedure, or change of sources. NOTE 1. It is recommended
42、 that control procedures are in accordance with the EN ISO 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 8) is used as a reference. For food prod
43、ucts, standards and guidelines of the Codex Alimentarius (see annex A 9) should be applied. Methods of AOAC International (Association of Official Analytical Chemists) (see annex A 10) or any other valid methods should be used whenever appropriate. 4.3 Verification of raw material before use 4.3.1 G
44、eneral Verification assays, which differ from industry to industry, to assure specifications can be as simple as a visual observation or as complicated as a simulation of the production conditions at pilot scale. Some techniques of verification are given in 4.3.2 and 4.3.3 and should be applied wher
45、e appropriate.Page 5 EN 1826 : 1996 BSI 1997 Figure 1. Procedure for raw material controlPage 6 EN 1826 : 1996 BSI 1997 4.3.2 Verification upon receipt For each consignment, the containers should be checked for integrity of package and seal and for correspondence between the order, the delivery note
46、 and the suppliers labels. If specified, a quality certificate should be delivered by the supplier. Damage to containers and/or deviations of specifications which might adversely affect the quality of a material should be documented. Samples should be taken using adequate sampling procedures for ana
47、lysis; if quick methods exist these can be performed upon receipt of the product prior to its unloading (in the case of bulk delivery). Depending on the result of raw material control procedures concerning step verification upon receipt in figure 1, the material will either be released for the biote
48、chnological process or will go into quarantine. 4.3.3 Quarantine verification In order to guarantee that specifications are upheld, adequate test methods (i.e. using validated procedures) should be applied to the samples taken. If on analysis the product is not within the specifications then it shou
49、ld be rejected. Appropriate labelling and record keeping should be done in accordance with good manufacturing practice (see annex A 7) where relevant. NOTE. 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 the stor
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