SANS 489-2009 Good Manufacturing Practice in the animal feed industry《动物饲料行业的良好生产规范》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22304-5 SANS 489:2009Edition 1SOUTH AFRICAN NATIONAL STANDARD Good Manufacturing Practice in the animal feed industry Published by SABS St

4、andards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 489:2009 Edition 1 Table of changes Change No. Date Scope Foreword This South African standard was approved by National Committee SABS SC 1025B, Hygiene prac

5、tices in the food industry Hygiene practices in animal feed manufacturing, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in September 2009. A reference is made in 2.6 to “a registered Animal Scientist“.

6、In South Africa this means an individual registered as a Professional Natural Scientist in the field of Animal Science in accordance with the Natural Scientific Professions Act, 2003 (Act No. 27 of 2003). A reference is made in 3.3.3, 5.4.7, 5.9.2 and 10.2 to the verification of new products and ser

7、vices, records of formulation for each batch produced, the retaining of the sample and the maintenance of quality records, respectively, in accordance with the applicable requirements of “the current relevant national legislation”. In South Africa this means the Fertilizers, Farms Feeds, Agricultura

8、l Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947). A reference is made in 4.1 to buildings that comply with hygiene and sanitation requirements under “the current relevant national legislation“. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993).

9、A reference is made in 7.1.3 to “accredited methods“ used to analyse the quality of products. In South Africa this means methods accredited by an organization that is signatory to the International Accreditation Forum Mutual Recognition Arrangement. The South African National Accreditation System (S

10、ANAS) is an example of such an organization. SANS 489:2009 Edition 1 1 Contents Page Foreword 1 Scope . 3 2 Definitions 3 3 Requirements for quality systems . 5 3.1 Management responsibilities. 5 3.1.1 Quality policies 5 3.1.2 Organizational structure 5 3.1.3 Management reviews 6 3.2 Quality systems

11、. 6 3.2.1 General 6 3.2.2 Quality system procedures . 6 3.2.3 Quality control plans 7 3.2.4 Product specifications . 7 3.3 Quality standard requirements 7 3.4 Purchasing 7 3.4.1 General 7 3.4.2 Assessment of suppliers . 8 3.4.3 Purchasing data 8 3.4.4 Acceptance of orders 8 3.5 Document and data con

12、trol 8 3.5.1 General 8 3.5.2 Approval and issuing of documents and data. 9 3.6 Control of customer-supplied products . 9 4 The plant 9 4.1 General 9 4.2 Plant layout 10 4.3 Birds, pets and vermin control. 10 4.4 Installations . 10 4.5 Industrial hygiene 10 5 Trade and production of compound feed and

13、 premixes 11 5.1 General 11 5.2 Receiving feed ingredients 11 5.3 Storage for premixes. 12 SANS 489:2009 Edition 1 2 Contents (concluded) Page 5.4 Production sequences. 12 5.5 Weighing equipment . 12 5.6 Requirements for processing and mixing ingredients. 13 5.7 Conveying systems . 13 5.8 Pelletizin

14、g 13 5.9 Shelf life and treatment . 13 5.10 Returns 14 5.10.1 General . 14 5.10.2 External returns. 14 5.10.3 Internal returns 15 6 Inspection. 15 6.1 General . 15 6.2 Final inspections . 15 6.3 Hygiene inspections 15 6.4 Inspections and test records. 15 7 Control, calibration and maintenance of ins

15、pection, measuring and test equipment 16 7.1 General 16 7.2 Control and inspection procedures . 16 8 Control of noncomplying products 16 8.1 General . 16 8.2 Noncompliance review and disposal 17 8.3 Corrective action. 17 8.4 Preventive action 17 9 Handling, storage, packaging, preservation and deliv

16、ery 18 9.1 General . 18 9.2 Handling and storage . 18 9.3 Packaging, preservation and delivery. 18 10 Quality records . 19 11 Internal quality audits . 19 12 Training 19 Bibliography. 20 SANS 489:2009 Edition 1 3 Good Manufacturing Practice in the animal feed industry 1 Scope This standard covers th

17、e trade and production of compound feed, simple and moisture-rich animal feed, animal feed ingredients, and premixes for the animal feed industry to ensure that the delivery of products and services by manufacturers of these products and providers of these services consistently meet the requirements

18、 laid down by law, with regard to human, animal and environmental safety. NOTE 1 The ability of the feed manufacturer and the premix manufacturer or the feed ingredients supplier or the raw materials supplier (or all three) to show that the quality is assured via a quality guarantee system is the ba

19、sis for the systematic control in the animal feed production chain. NOTE 2 The areas of attention in maintaining quality standard requirements in the framework of Good Manufacturing Practice (GMP) regulation of the animal feed industry involve the control of the following: the use of additives and i

20、n-feed veterinary medicines; the levels of undesirable substances and products; and hygienic work methods (control of microbiological conditions). 2 Definitions For the purposes of this document, the following definitions apply. 2.1 acceptable acceptable to the authority administering this standard

21、2.2 compound feed mixtures of feed ingredients, whether or not containing additives, which are intended for oral animal feeding as a complete or complementary feeding stuff 2.3 contamination undesirable matter occurrence of any substance that could ruin the product 2.4 contract agreed requirements,

22、transmitted by any means, between a supplier and a customer SANS 489:2009 Edition 1 4 2.5 cross-contamination additives or in-feed veterinary medicines and feed ingredients, mixed in an animal feed, that remain behind during the production process and, as a result, end up in the next batch of premix

23、 or animal feed 2.6 feed formula document that contains at least a list of ingredients and the ratio in which they must be mixed, formulated by a registered Animal Scientist (see foreword) 2.7 Good Manufacturing Practice GMP combination of manufacturing and quality procedures aimed at ensuring that

24、products are consistently manufactured in accordance with product specification requirements and at avoiding contamination of the products by internal or external sources 2.8 manufacturer feed manufacturer and premix manufacturer or feed ingredients supplier or the raw materials supplier (or all thr

25、ee) to whom the GMP code applies 2.9 micro bins small holding silos for the automated addition of ingredients 2.10 non-target animal animal for which a particular additive or in-feed veterinary medicine is not intended 2.11 organization company group of people and facilities with an arrangement of r

26、esponsibilities, authorities and relationships NOTE Examples of organizations are corporations, firms, enterprises, institutions, charities, sole traders, associations, or parts or combinations thereof. 2.12 pellet particle formed from compounded material, cut out to the desired length and then drie

27、d NOTE Pelletizing also refers to the formation of a particle from wet extruded material that is cut in varying shapes and dried. This particle is then referred to as a kibble. 2.13 premix uniform mixture of one or more micro-ingredients, additives or in-feed veterinary medicines with diluent or car

28、rier (or both) 2.14 purchaser person who purchases products or services (or both) for or from a feed manufacturer SANS 489:2009 Edition 1 5 2.15 quality standard document that details a set of quality requirements that control how materials, products, services, technologies, processes and systems ar

29、e managed 2.16 supplier person who sells or trades products to the feed manufacturer and the premix manufacturer or the feed ingredients supplier or the raw materials supplier (or all three) 2.17 traceable ability to follow the movement of a feed through specified stage(s) of production, processing

30、and distribution 2.18 treatment application of the modification process to feed ingredients or feed with the aim of reducing or removing microbiological contamination through a thermal, chemical or mechanical process or a combination thereof 3 Requirements for quality systems 3.1 Management responsi

31、bilities 3.1.1 Quality policies 3.1.1.1 The management shall define and document its commitment, policy and objectives for quality. The quality policy shall be relevant to the objectives and to the quality standard as laid down in the GMP manual. The management shall ensure that this policy is under

32、stood, implemented and maintained at all levels within the organization. 3.1.1.2 The organization shall implement, maintain and review its quality objectives. 3.1.1.3 The management shall initiate action to prevent the occurrence of noncompliance in products and services with regard to quality stand

33、ard requirements, even if these occur as the result of the quality system. 3.1.1.4 The policy shall mention the organizations involvement in the feed supply chain by including references to feed hygiene, safety and all other aspects of feed quality. 3.1.1.5 The management shall adhere to a commitmen

34、t to comply with quality standard requirements and continually improve on the effectiveness of the quality management system. 3.1.1.6 The management shall organize the treatment of noncomplying products until the deficiency or the unsatisfactory condition has been corrected. 3.1.2 Organizational str

35、ucture 3.1.2.1 Resources 3.1.2.1.1 The feed manufacturer shall ensure that all installations and equipment comply with the specified standards and requirements. SANS 489:2009 Edition 1 6 3.1.2.1.2 The feed manufacturer shall also be responsible for the provision of trained personnel for managing and

36、 implementing work and verification activities, including internal and external quality audits, by providing funds and labour. 3.1.2.1.3 The management shall ensure that customer satisfaction is obtained by meeting customer requirements. 3.1.2.2 Responsibilities and authority 3.1.2.2.1 Responsibilit

37、ies and authority shall be defined and communicated within the organization. 3.1.2.2.2 An organogram of the organizational structure, showing the relevant qualifications and positions of all employees, shall be displayed. 3.1.2.2.3 The responsibility of top management shall be to ensure that the org

38、anizations policies, objectives and the required customer satisfaction are met. 3.1.2.3 Management representatives 3.1.2.3.1 The management shall appoint a management representative who, irrespective of other responsibilities, shall have a defined authority. 3.1.2.3.2 The management representative s

39、hall report to the management on the functioning of the quality system for review and as a basis for its improvement. 3.1.2.3.3 The management representative shall serve as the contact for external personnel on matters related to the quality system. 3.1.3 Management reviews The quality system adopte

40、d to satisfy the requirements of this standard shall be reviewed at least once a year by the manufacturers management to ensure its continuing suitability and effectiveness. Records of such reviews shall be maintained. 3.2 Quality systems 3.2.1 General 3.2.1.1 Either the manufacturer or the supplier

41、 (or both) shall draw up, establish and maintain a documented quality system as a means of ensuring compliance of products or services to the quality standard requirements. 3.2.1.2 A quality control manual which covers the requirements of this standard shall be provided by the manufacturer or the su

42、pplier (or both). 3.2.1.3 Any deviation from the requirements of this standard shall be recorded. 3.2.2 Quality system procedures 3.2.2.1 The quality system and its documented procedures, which include tasks, responsibilities and authority for personnel, shall be implemented efficiently. 3.2.2.2 The

43、 procedures that form part of the quality system shall be harmonized with the complexity of the work and the respective employment levels of the personnel involved. SANS 489:2009 Edition 1 7 3.2.3 Quality control plans 3.2.3.1 The company shall establish a quality control plan that shall detail how

44、the critical points shall be controlled in the order of the production process. 3.2.3.2 All relevant checks and inspections shall be documented in the quality control plan. In drawing up this plan, attention shall be given to: a) the referral to procedures and instructions for the sampling of produc

45、ts, the handling of samples, inspections and testing; b) the frequency of tests, sampling, inspections and checks; c) persons responsible for the tests, sampling, inspections and checks; d) test equipment, inspection equipment and the proficiency that is necessary to control the quality; e) the requ

46、irements specified for testing and for control; and f) whether a system of retention of samples that is appropriate to the product type is in place. 3.2.4 Product specifications The quality system shall comprise, as a minimum requirement, the requirements for animal feed, additives, in-feed veterina

47、ry medicines, premixes or animal feed ingredients in the product specification. 3.3 Quality standard requirements 3.3.1 The manufacturer, the supplier or any external contractors, including transporters, shall ensure that the products or services comply with the quality standard requirements in the

48、framework of the GMP. 3.3.2 The manufacturer or supplier (or both) shall document all standards and requirements with regard to the quality standard for products to be delivered, including requirements which indicate to what extent the designated animal feed ingredients or products may deviate from

49、this standard. 3.3.3 Before any new products or services can be included in the delivery programme, it shall be verified whether all the applicable requirements of the current relevant national legislation (see foreword) and quality standard requirements in the framework of the GMP are met, and records shall be kept. 3.4 Purchasing 3.4.1 General 3.4.1.1 The feed manufacturer and the premix manufacturer or the feed ingredients supplier or the raw materials supplier (or all three) shall ensure that purchased products meet the specified requirements for the quality of feed. 3.4.