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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 materials Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 G
3、MT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1826 : 1997 This British Standard, having been prepared under 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 refe
4、rences relate to the work on this standard: Committee reference CII/58 Draft for comment 95/120896 DC ISBN 0 580 26890 X Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical
5、Committee CII/58, Biotechnology, upon which the following bodies were represented: Association of Consultants to the Bioscience Industries (Acbi) Bioindustry Association BLWA Ltd. (Association of the Laboratory Supply Industry) Brewing Research Foundation International British Agrochemicals Associat
6、ion Ltd. Chemical Industries Association Confederation of British Industry Department of Health Department of the Environment (air Climate and Toxic Directorate) Department of Trafe and Industry (National Engineering Laboratory) Health and Safety Executive Institution of Chemical Engineers Internati
7、onal Society for Pharmeceutical Engineering Ministry of Agriculture, Fisheries and Food Public Health Laboratory Service Society for Applied Bacteriology Society for General Microbiology Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN
8、1826 : 1997 i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 18263 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1826 : 1997 National foreword This British Standard has bee
9、n prepared by Technical 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
10、confer immunity from 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. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled
11、Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung 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 mem
12、bers. Ref. No. EN 1826 : 1996 E EUROPEAN STANDARDEN 1826 NORME EUROPE ENNE EUROPA ISCHE NORM September 1996 ICS 07.080 Descriptors: Biotechnology, raw materials, definitions, storage quality, inspection English version Biotechnology Large-scale process and production Control procedures for raw mater
13、ials Biotechnologie Proce de a grande e chelle et production Proce dures de contro le pour les matie res premie res Biotechnik 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
14、/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard 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
15、any CEN member. This European Standard exists 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.
16、 CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland,France,Germany,GreecemIceland,Ireland,Italy,Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, U
17、ncontrolled Copy, (c) BSI 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 shall be given the status of a national standard, either by publication of an
18、 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 organizations of the following countries are bound to implement this European S
19、tandard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword3 0Introduction3 1Scope3 2Normative references3 3Definitions3 4Raw material control4 Anne
20、x A (informative) Bibliography7 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 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
21、 harmful microbial contaminants: 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 t
22、ime when a raw material 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 mat
23、erials used in 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
24、by means of a biotechnological 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, p
25、rovisions from other publications. 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
26、it by amendment or revision. For undated references the latest edition of the publication referred to applies. ISO 11014-1Safety 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 Tota
27、lity of unit operations 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 biotec
28、hnological process. 3.4 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
29、 specification. NOTE 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
30、quality assurance is 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. H
31、owever, users can, in 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 a
32、ssay Assay used to determine whether the material meets the specifications. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1826 : 1996 BSI 1997 4 Raw material control 4.1 General The purchase of raw materials should involve person
33、nel who have experience or knowledge of the product and suppliers. A list should be established that guarantees control of the properties 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 t
34、he protective measures for workers to be applied, where appropriate, when handling raw materials (see annex A 5). The relevance of 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 m
35、aterial used for each process should be established and followed. It is recommended that a validation record is kept by documenting all important facts concerning the raw materials. Amongst the raw materials that should be taken into consideration are the following: water; carbon and nitrogen source
36、s; additional nutrients (e.g. minerals, vitamins); additives, acid, base, antifoam; auxiliary materials (e.g. enzymes, filtration 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
37、 air; process steam condensed into the fermenter during sterilization by direct steam; cleaning materials. NOTE 3. Cleaning materials 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 r
38、aw materials should be followed by the suppliers. The receiving company should be informed in writing about any deviations. It is 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 n
39、ational, European and international regulations concerning the control of raw material for food and pharmaceutical products. 4.2 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 th
40、at 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 should be checked against the agreed specifications. Validated data from certified suppliers can be used. The following items should be considered
41、, if relevant: label description; packaging integrity and size; identity of the raw material; batch traceability (identification, origin country, batch number and other labelling); storage conditions; health safety and environmental rules related to the raw material (for material safety data sheet,
42、see ISO 11014-1); qualitative assays in agreement with standards; purity and impurity assays agree with specifications; distribution 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 (
43、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 raw materials of biological origin with complex composition, where quality cannot be specified precisely, the supplier shou
44、ld inform the receiving company of any major changes in the production procedure, or change of sources. NOTE 1. It is recommended 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
45、(GMP) rules (see annex A 7) are also applied and the European Pharmacopoeia (see annex A 8) is used as a reference. For food products, standards and guidelines of the Codex Alimentarius (see annex A 9) should be applied. Methods of AOAC International (Association of Official Analytical Chemists) (se
46、e annex A 10) or any other valid methods should be used whenever appropriate. 4.3 Verification of raw material before use 4.3.1 General 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
47、the production conditions at pilot scale. Some techniques of verification are given in 4.3.2 and 4.3.3 and should be applied where appropriate. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 1826 : 1996 BSI 1997 Figure 1. Procedur
48、e for raw material control Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 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 corres
49、pondence 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 specifications which might adversely affect the quality of a material should be documented. Samples should be taken using adequate sampling procedures for analysis; if quick methods exist these can be performed upon receipt of the product prior to its unloading (in the case of bulk deli
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