Cross-reference table GMP+ Standard B2 (2010) and + GMP Standard B2

In the following table there are references from the GMP+ Standard B2 (2010), published on 3 December 2009 to the current GMP+ Standard B2 version 24 July 2009, which was originally published in 2006. The tables provide general references to corresponding requirements in the standard specified. The references are also not exhaustive. Parts of certain requirements may also be included in other articles of the new standard. In order to obtain insight at the detailed level into the changes, you should always first go through the complete new standard. No rights may be derived from the use of this table.

Cross-reference table + + GMP B2 (2010) ---> GMP B 2

1 of 4 PDV

GMP B2 (2010) 1. Introduction 1.1 General + 1.2 Structure of the GMP certification scheme 1.3 Scope and application of this standard 1.4 The structure of this standard 1.5 Exclusion from requirements 2. Normative references + 2.1 GMP Documents 2.2 Legal compliance 3. Terms and definitions 4. The feed safety system 4.1 Management: responsibility and involvement 4.2 HACCP team 4.3 The feed safety system 4.4 Documentation and registration 5. Prerequisite programmes 5.1 Personnel 5.1.1 General 5.1.2 Competency and training 5.2 Infrastructure 5.2.1 Environment 5.2.2 Facilities and equipment 5.2.2.1 General 5.2.2.2 Intake and loading facilities 5.2.2.3 Storage facilities 5.2.2.4 Equipment 5.2.3 Access regulation 5.2.4 Other items 5.2.4.1 Cross-contamination 5.2.4.2 Air movement 5.2.4.3 Water and steam 5.2.4.4 Processing Aids and Technological Additives 5.2.4.5 Packaging 5.3 Maintenance and hygiene management 5.3.1 Maintenance 5.3.2 Maintenance of measuring equipment 5.3.3 Cleaning & sanitizing 5.3.4 Pest prevention and control 5.3.5 Waste management 5.3.6 Glass and breakable materials 5.4 Identification and traceability / sampling
Cross-reference table + + GMP B2 (2010) ---> GMP B 2

GMP B2 (originally published in 2006)

Remarks

1. Introduction 2.1 Scope 2.2 Normative reference 3. Definitions 4.1.1 Awareness 4.1.5 Management responsibility 4.1.2 Quality control system 4.1.3 Quality control documentation 4.1.5 Management responsibility 5.6 section Hygienically working 4.1.5 Management responsibility 5.6 section Site, building and process equipment requirements 5.6 section Site, building and process equipment requirements 5.6 section Site, building and process equipment requirements 5.6 section Site, building and process equipment requirements 5.6 section Intake & loading facilities 5.6 section Storage 5.6 section Conveyors and handling equipment 5.6 section Contamination with specific contaminants 5.6 section Steam injection 5.6 section Technical and technological aid agents 5.6 section Site, building and process equipment requirements 5.6 section Site, building and process equipment requirements 5.6 section Site, building and process equipment requirements 5.6 section Cleaning 5.6 section Pest control program 5.6 section Identification and traceability of feed materials

New Scope has changed!! New New

New

New

New New

New

New

New New

2 of 4 PDV

GMP B2 (2010)

GMP B2 (originally published in 2006) 5.4.1 Identification and traceability 5.6 section Identification and traceability of feed materials 5.4.2 Sampling 5.6 section Identification and traceability of feed materials 5.5 EWS and recall 6. HACCP 5. Specific requirements 6.1 Planning of the realisation of a safe 5.1 General feed 6.2 Description of products and 5.2 Product specification process 5.3 Production process specification 6.2.1 Determiniaton of requirements 5.2 Product specification 6.2.2 Specification of feed ingredients 5.2 Product specification 6.2.3 Process description 5.3 Production process specification 6.3 Hazard analysis 5.4 Hazard Identification 5.5 Risk evaluation and determination of critical control points 6.3.1 Hazard identification 5.4 Hazard Identification 6.3.2 Risk assessment 5.5 Risk evaluation and determination of critical control points 6.4 Establishing control measures and 5.6 Control measures for critical critical control points (CCPs) control points 6.5 Establishing critical limits 5.7 Monitoring and verification 6.6 Monitoring 5.7 Monitoring and verification 6.7 Corrective actions 5.6 section Control of non conforming products 6.8 Validation and verification 5.7 Monitoring and verification 7. Control of operational activities 7.1 Purchase 4.3 Basic requirements for purchase (4.2 Basic requirements for traders) 7.2 Verification of received products 7.3 Storage 4.5 Basic requirements for storage

Remarks

New

Please note that it is no longer possible to trade feeds that are not produced by the participant. New Please note that it is no longer possible to store feeds as a service for a third party, that are not produced by the participant.

7.4 Production 7.5 Sale & contracts 7.6 Labelling and delivery requirements 7.7 Transport 7.7.1 General 7.7.2 Road transport with own means of transport 7.7.3 Road transport, carried out by subcontractors 7.7.4 Road transport, contracted by third parties (participant is not responsible for transport) 7.7.5 Transport via inland waterway, by sea and by rail 8. Verification and improvement 8.1 Complaints 8.2 Internal audit

5.6 Control measures for critical control points 4.1.6.1 Contracts 4.1.6.2 Order receipt & processing 4.1.6.3 Packaging and delivery documents 4.4 Basic requirements for transport 4.4 Basic requirements for transport 4.4 section Road transport 4.4 section Road transport 4.4 section Road transport

4.4 section Transport by inland waterway, sea and rail

4.1.7 Complaints 5.8 Evaluation, actualisation and communication

3 of 4 PDV

Cross-reference table + + GMP B2 (2010) ---> GMP B 2

GMP B2 (2010) 8.3 Management review and improvement

GMP B2 (originally published in 2006) 5.8 Evaluation, actualisation and communication

Remarks

Cross-reference table + + GMP B2 (2010) ---> GMP B 2

4 of 4 PDV