1. Scope of this document

This document contains assessment and certification/inspection criteria for:

• Feed Responsability Assurance Module (FRA) module,
• Inland waterway transport and short sea shipping of feed (based on ISO/IEC17020),
• Laborary testing and registered laboratoies (based on ISO/IEC17025).

2. Normative references

The following documents, in whole or in part, are normatively referenced in this document and are mandatory to comply with. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

• ISO/IEC 17020:2012 Conformity assessment – requirements for the operation of various type of bodies performing inspection.
• ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
• F0.1 Rights and Obligations.
• F0.2 Definition list
• F0.3 Scopes for certification.
• CR1.0 Acceptation requirements.
• CR2.0 Assessment and Certification

3. Terms and Definitions

For GMP+ definitions see F0.2 Definition list. Throughout this document the terminology “through the Certification Body” is used indicating that all activities performed by critical-, non-critical locations and outsourcing party are conducted under the responsibility/liability of the GMP+ accepted Certification Body.

4. Process requirements

4.1. Pre-certification activities

4.1.1. Application

The Certification Body must require an authorized representative of the applicant organization to provide the necessary information to enable it to establish the following:

1. the desired scope of the certification;
2. relevant details of the applicant organization as required by the specific certification scheme, including its name and the address(es) of its site(s), its processes and operations, human and technical resources, functions, relationships and any relevant legal obligations;
3. identification of outsourced processes used by the organization that will affect conformity to requirements;
4. the standards or other requirements for which the applicant organization is seeking certification;

And if applicable:

5. Number of analysis;
6. Accredited analysis;
7. Partly accredited analysis
8. Not accredited analysis.

Relevant details of the applicant organization including its name and addresses as specified in the official legal business registration by the competent authority and information as mentioned in Appendix 1 of this document. In addition the 5^th bullet of article 5.1.1. of the CR2.0 Assessment and Certification, applies.

4.1.2. Application review

Before proceeding with the audit, the Certification Body will carry out a review of the application and additional information for certification to ensure that:

1. the information about the applicant organization and its management system is sufficient for the conduct of the audit;
2. any known difference in understanding between the Certification Body and the applicant organization is resolved;
3. the Certification Body has the competence and ability to perform the certification activity;
4. the scope of certification sought, the location(s) of the applicant organization's operations, time required to complete audits and any other points influencing the certification activity are taken into account (language, safety conditions, threats to impartiality, etc.);
5. records of the justification for the decision to undertake the audit are maintained.

The certification body, following the review of the application, must either accept or decline an application for certification (the reasons for declining an application, the review of the application, must be documented and made clear to the client).

Based on the review, the Certification Body must determine the competences it needs to include in its audit team and for the certification decision.

The Certification Body must not exclude activities, processes, products and services from the scope of certification when these can have an influence on the feed safety. The application review is mandatory.

4.1.3. Certification agreement

Article 5.1.3 of the CR2.0 Assessment and Certification is applicable. In deviation on requirement 5.1.3.b, the minimum obliged audit/inspection time per scope(s)/standard(s) as stated in Appendix 1 of this document per audit type is applicable, referring to Appendix 1 is insufficient.

4.1.4. Audit and Inspection team assignment

Persons who are performing the audit/inspection must comply with the applicable requirement of Appendix 2 and Appendix 3 (if applicable) of the CR1.0 Acceptation requirements.

4.1.5. Rotation of auditors and inspectors

Rotation of auditors scope Laboratory testing :

• Article 5.1.5.1 of the CR2.0 Assessment and Certification is applicable.

Rotation of auditors/technical expert scope registered laboratory :

• The auditor and technical expert may only perform the desk study of the same GMP+ Certified Company six consecutive times. Then rotation of the auditor and technical expert must take place

Rotation of Inspector :

• A new inspector must be assigned after 3 consecutive inspections.

Rotation of FRA auditors :

• Article 5.1.5.1 of the CR2.0 Assessment and Certificationis applicable.

4.1.6. Audit plan

For FRA an audit plan for each type of audit must be send to the GMP+ Certified Company prior to the audit.

For the scope Laboratory testing, for each type of audit an audit plan must be sent to the GMP+ Certified Company prior to the audit.

4.2. Certification process

4.2.1. Audit and Inspection

4.2.1.1. General

Article 5.2.1.1. of the CR2.0 Assessment and Certification is applicable. The minimum obliged audit/inspection frequency and audit times are determined in Appendix 1 of this document. In deviation of article 5.2.1.1.:

1. The assessment for the scope Registered laboratory will be performed by means of a desk study (or on site if applicable).
2. The administrative assessment of the scope Laboratory testing, if all analyses are accredited in accordance with ISO/IEC17025 must be performed once per year.
3. On site assessment of the scope Laboratory testing if not all analyses are accredited in accordance with ISO/IEC17025 must be performed once per year for the non-ISO/IEC 17025 accredited analyses.
4. On site assessment of the scope Laboratory testing if the laboratory is not accredited in accordance with ISO/IEC17025 must be performed once per year for system assessment.

4.2.1.2. Initial certification Audit and inspection

An initial certification audit/inspection will be performed through the Certification Body in order to assess whether the company meets the criteria set out in Appendix 1 of the CR2.0 Assessment and Certificationor in the GMP+ checklist Inland waterway transport and short sea shipping of feed. The initial certification audit/inspection must be conducted within 3 months after concluding an certification agreement with the applicant organization.

Scope Laboratory testing:

The initial certification audit is an assessment of the quality system/documentation. The most important analyses must be assessed during the initial certification audit. All analyses must be assessed during the certification cycle.

4.2.1.3. Temporary acceptance

The text of article 5.2.1.3.1 of the CR2.0 Assessment and Certificationis applicable.

4.2.1.4. Surveillance audits

The first surveillance audit must be executed each 12 months, plus and minus 2 months, after the certification decision date.

The second surveillance audit must be executed each 24 months, plus and minus 2 months, after the certification decision date.

4.2.1.5. Announced surveillance audits

An announced surveillance certification audit will be performed during the period of validity of the GMP+ certificate through the Certification Body in order to assess whether the company meets the criteria set out in Appendix 1 of the CR2.0 Assessment and Certification. The frequency and the audit times of the announced surveillance audit are determine in Appendix 1 of this document.

4.2.1.6. Unannounced surveillance audits

See article 4.2.1.5 above. In addition if the FRA module is audited together with the FSA module the audit will be performed unannounced for all scopes.

4.2.1.7. Recertification audit/ inspection

Prior to the extension of validity of a certificate a re-certification audit/inspection must be carried out through the Certification Body.

A GMP+ certificate may or may not be extended by the Certification Body based on the assessment criteria as specified in Appendix 1 of the CR2.0 Assessment and Certification or in the GMP+ checklist Inland waterway transport and short sea shipping of feed.

Before the period of validity of the certificate expires, the total certification process must be finished including updating of the GMP+ company database (status and data of certificate) through the Certification Body. If a recertification audit is not carried out before the expiration date of the validity of the certificate, then an initial certification audit must be carried out. The company is in the intervening period not GMP+ certified.

4.2.1.8. Expansion audit

Article 5.2.1.6. of the CR2.0 Assessment and Certificationis applicable.

4.2.2. Special audits and Inspections

The following audits/inspections can be applicable, assessment must be done in accordance with Appendix 1 of the CR2.0 Assessment and Certification or the checklist Inland waterway transport and short sea shipping of feed.

4.2.2.1. Stricter supervision Audit (SSA)

Article 5.2.2.1. of the CR2.0 Assessment and Certificationis applicable.

4.2.2.2. Repeat audit (RPA) and Repeat Inspection (RI)

Article 5.2.2.2. of the CR2.0 Assessment and Certificationis applicable.

In deviation, the reason for a repeat inspection may be an EWS alert, complaints or incidents, or other special circumstances. In principle the repeat inspection is aimed on these reason(s) but can also be aimed at all requirements of the GMP+ Feed Certification scheme.

1. GMP+ International may ask the Certification Body to carry out a repeat inspection on short term in principle in the presence of a GMP+ International auditor and/or a technical expert.
2. The repeat inspection must be carried out by a GMP+ inspector. The involved Certification Body must motivate the choice of the GMP+ inspector and document its decision.
3. The deadline will be assessed per case but ultimately determined by GMP+ International.
   The inspection will be on the vessel. Administrative checks and a sampling may be carried out.
4. The required appointments and communication on this will be made with the GMP+ Certified Company through the Certification Body in consultation with GMP+ International.
5. In principle the costs of the repeat inspection will be at the expenses of GMP+ International. However, if it appears that 1 or more requirements with text in the guidance “Non Conform” in the checklist are observed, the costs will be charged to the GMP+ Certified Company.

4.2.3. Extraordinary events

Article 5.2.3. of the CR2.0 Assessment and Certification is applicable.

4.2.4. Identifying and Recording Audit and Inspection findings

If the applicant organization/GMP+ Certified Company does not comply with the applicable requirements of the GMP+ Feed Certification scheme, the sanctions as specified in Appendix 1 of the CR2.0 Assessment and Certification apply.

For the scope Inland waterway transport and short sea shipping of feed the following applies: If a “Not Conform” with a description is observed, a GMP+ certificate cannot be issued. The GMP+ certificate can only be issued if the “Not Conform” with a description is resolved

4.2.5. Audit report

The text of article 5.2.6. of the CR2.0 Assessment and Certificationis applicable.

In deviation, a checklist has to be completed for the scope Inland waterway transport and short sea shipping of feed and uploaded in the GMP+ database within 8 weeks after the execution of the inspection on site. Within 8 weeks following the execution of the inspection on site, the final checklist must be sent to the GMP+ Certified Company together with any data from the certificate or the temporary acceptance. In the event of a repeat inspection, GMP+ International must have received the final checklist within 5 working days.

4.2.6. Review

Article 5.2.7. of the CR2.0 Assessment and Certificationis applicable. In addition, review of the checklist Inland waterway transport and short sea shipping of feed is mandatory.

4.2.7. Certification decision

The certification decision must be based on:

1. For any type of nonconformities/non conforms, the Certification Body has reviewed, accepted and verified the correction and corrective actions;
2. Assessment of the applicant organization/GMP+ Certified Company took place in accordance with Appendix 1 of the CR 2.0 Assessment and Certification and the checklist Inland waterway transport and short sea shipping of feed. If in the description of nonconformities is referred to feed safety, for the FRA scopes, feed safety is not applicable.
3. The assessment and decision of a Certification Body must be demonstrably based on objective evidence of conformity and non-conformity obtained.

4.2.8. Certificate and Temporary acceptance

4.2.8.1. Certificates/ Statement

A certificate has the following maximum validity:

• FRA certificates (all MI 5.1, MI 5.2, MI 5.3, MI 5.4 and MI 5.6) 3 years,
• FRA statement (MI 5.5): 14 months
• Scope Laboratory testing 3 years,
• Scope Registered laboratory 3 years,
• Scope Inland waterway transport and short sea shipping of feed 2 years,

calculated from the date of a positive certification decision. Within 8 weeks following the execution of the audit/inspection on site, the Certification Body will send the certificate/ statement to the applicant organization/GMP+ Certified Company. The duration of the GMP+ certificate/ statement must not exceed the validity of the certification agreement.

For FRA multi-site certificate see article 5.2.9.1 of the CR2.0 Assessment and Certification

4.2.8.2. Temporary acceptance

A temporary acceptance with a maximum period of validity of 4 months may be issued by the Certification Body. However, if during the initial certification audit on site (if applicable), the applicant organization does not appear to comply the GMP+ requirements conform Appendix 1 of CR2.0 Assessment and Certification then the temporary acceptance must be withdrawn. The duration of the temporary acceptance must not exceed the validity of the certification agreement.

For FRA multi site temporary acceptance see article 5.2.9.2 of CR2.0 Assessment and Certification.

4.2.8.3. Certificate and Temporary acceptance templates:

The Certification Body must put the following text on the certificate or temporary acceptance:

1. Text for a certificate

2. Text for a certificate for the scope Registered laboratory:

3. Text for temporary acceptance

4. Text for statement

In addition the following applies:

1. The data of the GMP+ Certified Company/temporary accepted company must exactly be the same as registered in the legal business registration. (for example Chamber of Commerce/registration at competent authority, tax/vat number)
2. It is mandatory to show the GMP+ FSA/FRA logo on the certificate.
3. It is not permitted to use the GMP+ FSA/FRA logo on a temporary acceptance. In addition, the document may not be called a “certificate” but must be designated as a “temporary acceptance”.
4. It is not permitted to use the logos of Critical Location, non-Critical Location and Outsourced Party on the GMP+ certificate and temporary acceptance other than the GMP+ accepted Certification Body.
5. The begin date of the certificate/temporary acceptance is a date which is in any event equal or after the date of the positive certification/temporary acceptance decision.
6. In case of expansion of scopes the end date of the valid GMP+ certificate may not be extended. The Certification Body can also grant the GMP+ Certified Company a new GMP+ certificate for the additional scope.
7. It is not permitted to specify brand names in any way whatsoever on the certificate or temporary acceptance.

4.3. Suspension or Withdrawal of a Certificate Temporary acceptance

The text of article 5.3 of the CR 2.0 Assessment and Certification is applicable. In deviation, for the scope Inland waterway transport and short sea shipping of feed the following applies: If a “Not Conform” with a description is observed, the GMP+ certificate must be withdrawn. A GMP+ certificate can only be issued if the “Not Conform” with a description is resolved.

4.4. Transfer to another Certification Body

Article 5.4. of the CR 2.0 Assessment and Certification is applicable.

4.4.1. Pre-transfer review

Article 5.4.1. of the CR 2.0 Assessment and Certification is applicable. In deviation on article 5.4.1.d & e. for the scope Inland waterway transport and short sea shipping of feed the following applies:

An evaluation of the last checklist to established if a “Non Conform” with description were observed. This evaluation can include other relevant documentation, regarding the (re)-certification process i.e. notes, etc.

4.4.2. Certification process during transfer

Article 5.4.2. of the CR 2.0 Assessment and Certification is applicable. In deviation on article 5.4.2.b. for the scope Inland waterway transport and short sea shipping of feed the following applies:

Open “Non Conform” with description established during the last inspection must be closed by the accepting Certification Body/Critical location during the initial inspection.

4.4.3. Cooperation between the departing and accepting Certification Bodies

Article 5.4.3. of the CR 2.0 Assessment and Certification is applicable

5. Exclusion of GMP+ International Liability

Chapter 6 of the CR 2.0 Assessment and Certification is applicable.

6. Tariffs

Chapter 7 of the CR 2.0 Assessment and Certification is applicable.

7. Disputes between Certification Bodies and GMP+ certified companies

Chapter 8 of the CR 2.0 Assessment and Certification is applicable.

Appendix 1: Frequency and Audits/Inspection time

See Appendix 2 of the CR2.0 Assessment and Certification. In deviation, these audits/inspection times are including preparation, reporting, etc. and audit time reduction is not allowed, unless one of the footnotes is applicable.

Appendix 2: Multi-site certification

Appendix 4 of the CR 2.0 Assessment and Certification is applicable. In addition:

Multi-site certification is not permitted for the FSA scopes:

Laboratory testing,

Registered laboratory

Inland waterway transport and short sea shipping of feed.

Multi-site certification is not permitted for the FRA scopes:

• Production of compound feed,
• Production of premixtures,
• Production of feed materials,
• Production of feed additives.

Multi-site certification is permitted for the FRA scopes:

• Trade in feed - GMO controlled,
• Storage and Transshipment of feed - GMO controlled,
• Road transport of feed - GMO controlled,

Minimum obliged audit time in day’s per multi-site location