Terms, Rules and Conditions of Certification GMP+

Valid from 19th October 2015

These terms and conditions of GMP + certification to govern the contractual relationship between the customer and the certification body URS based on the accepted bid, which specifies the subject, scope and cost of certification.

Certification Scheme
In order to obtain and retain certification all clients to the scheme must adhere to the following procedures and rules of the scheme.
All information deemed necessary by United Registrar of Systems Czech s.r.o. (URS) in order to complete the audit / evaluation programme should be made available by the client.
URS shall be responsible for all actions of certification, from the initial audit/evaluation of the clients System through periodic surveillance visits and re-assessment, additional audits/evaluations. The GMP+ INTERNATIONAL has no liability whatsoever with respect to the assessment of companies by URS. URS is working due to actual GMP+ regulations. In case of changes of these GMP+ regulations URS stipulates right to one-side change of contract according to changes in GMP+ regulations.
URS shall inform the client of the initial audit/evaluation results and if not satisfied that all the requirements for the certification are being met, shall inform the client of those aspects in which the application is deemed non-compliant. The definition of non-conformities is according to the GMP+ regulations at the last revision.
When the client can demonstrate that effective remedial action has been taken to meet all the requirements within a specified time limit, URS will review the remedial action and determine the suitability of awarding certification.
All certificate holders will be entitled to provide feedback and suggestions relating to the potential areas for improvement. URS reserves the right to make minor changes and corrections to these „Terms,Rules and Conditions of Certification GMP+“ without prior notification. Clients will be given 1 month’s notice of any changes that affect their responsibilities or liabilities.
The client shall ensure that the question of responsibility to URS for the System is clearly defined, e.g. by appointing a designated person who is nominated to maintain contact with URS to ensure that the above provisions have been observed. The client shall permit scheme accreditation and GMP+ INTERNATIONAL representatives all reasonable access for the purpose of observing URS group auditors/evaluators performing initial audit/ evaluation and/or surveillance activities due to GMP+ and URS rules Accreditation representative and GMP+ INTERNATIONAL can use client’s documentation for accreditation purposes and/or approval.

Audit/Evaluation
Audits/evaluations shall be conducted against the clients procedures and the requirements of the GMP+ scheme and relevant legislation.
The audit report is to be sent to the GMP+ INTERNATIONAL in 6 weeks following the audit, when GMP+ International will ask that. The auditee should send the corrective actions with the corrective action plan in time set by auditor or set by GMP+ and URS rules.

Certification
When an initial audit/evaluation has been completed and systems deemed to be satisfactory by relevant Scheme Manager of URS he/she shall inform the client accordingly and issue a certificate.
Surveillance frequency is on a basis set by GMP+ INTERNATIONAL documents. However audits are to be scheduled according to the relevant GMP+ regulation. An additional visits may be conducted at the discretion of the URS group Scheme Manager or GMP+ INTERNATIONAL or accreditation organisation. The certificate is valid for 3 years. The certificate will remain the property of URS and shall be returned on request. All clients shall maintain a log of all complaints they receive which fall within the scope of registration for which a certificate has been awarded.

Selection of the Auditors team
The URS always selects an Auditor, suitable for the field of activity of the organization. The URS reserves the right to change the Auditor(s) to ensure his/their independence and objectivity, or if due to unforeseen circumstances, cannot ensure that the designated Auditor is available.
Duration of the Contract
The Contract is being concluded for a definite period of 3 years from the date of its signing by both Contracting Parties. The Contract may be prematurely terminated by agreement of the Contracting Parties. Any Contracting Party may withdraw from the Contract, if the other Contracting Party does not fulfil its contractual obligations, notwithstanding the fact that it was informed on the violation of the obligations in writing and did not make any remedy even within a reasonable time provided by the injured Party.

In case that the Client would terminate this Contract before expiration of 3 years, or failed to comply with his obligations under this Contract, the participants agreed to contractual fine amounting 33% of the payment for the unexhausted performance of the Appendix 1 of accepted contract. The contractual fine is not applicable for the client, who made a decision to not continue in the business activities related to GMP+ or announced a voluntary liquidation of the company.

Venue of performance
Assessment and facts finding required for the audit of the GMP+ be carried out by URS
- at premises of the assessed organization,
- as well as in remote locations of the organization.
- terms of the audits will be always determined based on a mutual agreement of the URS and the Client.
- certificates will be issued within 30 weeks from the date of the initial audit.

Rights and obligations of the Contracting Parties
Client’s obligations:
The Client undertakes to allocate an employee as a coordinator of the project within the organization. The employee shall ensure cooperation with other staff of the organization involved in the systems according to relevant standards.

The Client undertakes to follow these rules and regulations for certification GMP+ with which he was made familiar by the URS.

The Client undertakes to pay the price set out in accepted offer

The URS undertakes to ensure the highest-level co-operation with client’s staff - planning of terms of the certification audits, etc.

The URS shall not be liable for non-performance or delayed performance of his duties, caused by Force Majeure. Force Majeure means circumstances, especially those events, unpredictable at the time of conclusion of the Contract (natural disasters, industrial accidents, etc.), whose presence and influence significantly affects performance of the contract, giving neither to the Client nor to the URS any possibility to effectively prevent the affects by use of any legally available and reasonably requested means.

The Client undertakes to provide necessary co-operation to the URS during performance of Contract. The Client undertakes in particular:
- to ensure active cooperation of all his employees and other persons involved in his organization and as such being subject to GMP + standard mode;
- enable to the URS access to the objects and premises used by the organisation and related to the fulfilment of subject matter of Contract;
- to provide all necessary legal, economic and technical data and information relating to the Clients organization, for the purpose of performance of Contract.

The Client shall enable the owner of the standard of GMP + International and/or the Accreditation Body to take part in a witness audits and/or in parallel audits.

In case of any ambiguity between language versions, English language version of this Contract or its Annexes prevails.

The Client agrees that the URS carries out the audit in the local language (or in English, if the Auditor does not communicate in the local language). The URS shall secure his Audit Report in English and states findings/discrepancies in combination both of the local and English languages. If the Auditor does not speak the local language, so findings/discrepancies will be only in the English language. If the Auditor does not communicate in the language, the URS’s local office in the country will try to secure a person (translator) from own office, knowing both the local and English language, skilled in audit techniques, so as to be able to interpret Auditor’s questions relevant to GMP + standard. If the URS’s local office is unable to provide the translator from this office, the Client hereby agrees to ensure an English speaking interpreter for the audit at the Client’s own expenses. In case that Auditor does not communicate in the local language, the Client agrees to provide documentation in English at his own expense, containing at least the Quality Manual, or on Auditor’s request also HACCP risk analysis.

Early Warning System 
EWS  In the case of non-compliance with specified levels of contaminants, the customer is obliged to inform the EWS and submit a report within 12 hours after confirmation of contamination to its certification body, the relevant authorities and GMP + International. 

Confidentiality
All provided pieces of information will be treated as strictly confidential and except for Certification body or Accreditation body or Owner of the standard GMP + International will not be, without written permission of the Client, disclosed to anyone else.

The obligation of confidentiality does not apply to information already disclosed by the party owing the information or pieces of information publicly available or obtained independently of the parties participating in contractual relationships concerning the subject matter of this Contract, or obtained from third parties without any limitations.

Regardless the above provisions, the following pieces of information are not considered to be confidential:
- pieces of information that became publicly known without being caused intentionally or by any omission of the receiving party,
- pieces of information legally available to the receiving party prior to the conclusion of this Contract, unless such information is not subject to another, previously concluded agreements on protection of the pieces of information.
information resulting of a procedure to which the receiving party arrived independently and is able to demonstrate it by its records or by confidential pieces of information of a third party,
- if after signing of this agreement has
been given to the receiving party by a third party who does not obtained such pieces of information neither directly nor indirectly from the party that owns them.

Extending Certification
A Company wishing to extend its certificate to cover additional products, processes, services or sites shall apply to the Scheme Manager in writing. The Scheme Manager shall review the nature of extension and decide on the necessary audits/evaluations to be performed

Publicity by Certificate (holders) clients
A client has the right to publish that the product, process or service and company have been audited/evaluated by a member of the URS and apply a mark of conformity to promotional materials for which the certificate applies.
In every case, the client shall take sufficient care of its publications and advertising so that no confusion arises between certified and non-certified product, processes and/or services. The client shall not make any claim that could mislead purchasers to believe that a product, process, service, site or organisation is covered by the certification when in fact it is not.
The GMP+ certified companies are entitled to make use of the GMP+ logo of the (GMP+ INTERNATIONAL). The GMP+ certified company should undertake strict compliance with the conditions set by the GMP+ INTERNATIONAL.

Confidentiality
URS shall endeavour to ensure that its employees and agents maintain secrecy concerning all confidential information with which they become acquainted as a result of their contacts with the client. The reports will only be issued to URS, to the certified company, to the GMP+ INTERNATIONAL eventually or in case of need to accreditation body. The data is remained for 6 years. URS will provide information about its client or its activity in case that it is required by law or by relevant decisions of court or administrative authority.

Misuse of a Certificate
URS shall take all reasonable precautions to control the use of its certificates. Incorrect references to certifications or misleading use of certificates found in advertisements; catalogues, etc. shall be dealt with by suitable actions, which could include legal or corrective action or publicising the transgression. Clients are invited to report to the Scheme Manager any misuse of the URS group marks, accreditation and GMP+ marks which comes to their attention. The source of all information received will be treated in confidence.

Sanctions
The warnings, suspensions and cancelling of the certificate are done according to the GMP+ regulations latest revision.
All costs incurred by URS, in the suspending and reinstating of certificates will be charged to the client.
If it is established that the GMP+ certified company is no longer compliant with the certification conditions, URS will increase the audit frequency according to the relevant GMP+ regulation or revoke the certification.

Corrective Actions
When URS receives a report of certificate misuse the report shall be investigated. If misuse is substantiated, the cost of the investigation shall be paid by the certificate holder. URS will determine the scope of misuse and the type of corrective action to be undertaken.

Complaints against URS
Should the client have cause to complain regarding the conduct of URS’s staff, the complaint should be made in writing and addressed to the relevant Scheme Manager of URS group. Should the complaint be made against the Scheme Manager, the letter of complaint should be addressed to the Chairman of the GMP+ Committee. A client can send the compliant as well to GMP+ INTERNATIONAL due to actual GMP+ procedure.

Appeals Procedure
Notification of failure to comply with the requirements of certification may be given for, but not limited to, the following:
- deficiencies in management systems observed during initial audit or surveillance or additional visits, revealing non-conformity with certification requirements.
- misrepresentation or misuse of certification.
- misrepresentation or misuse of the Accreditation Body’s logo, Certification Body´s logo or GMP+ logo.
Client has the right to appeal against any notification given.
Notification of an organisations intention to appeal must be made in writing, and must be received by the relevant Scheme Manager of URS within fourteen days of receipt of notification of failure to comply with the certification requirements.
All appeals shall be submitted to the GMP+ Committee. The Scheme Manager of URS shall be required to submit evidence to the GMP+ Committee to support his decision to issue a notice of non-conformity.
Client has the right to object to involvement of particular members of the GMP+ Committee in the appeals procedure if evidence can be provided that their impartiality is compromised. The appellants also have the right to present their case in person at their own expense.
The decision of the GMP+ Committee shall be final and binding on both the organisation and URS. Once the GMP+ Committee has made a decision regarding an appeal, no counter claim by either party in dispute can be made to amend or change this decision.
Decisions on appeals will be made within 4 months of receipt of the appeal n instances where the appeal has been successful and the award made or reinstated, reimbursement of costs of appeals will only be made at the discretion of the GMP+ Committee.
If it does not lead to a resolution of the dispute, the dispute will then be handled in accordance with the disputes regulation as specified in GMP+ documents.

Fees
URS shall be entitled to charge fees at a level to be determined from time to time having regard to its costs relating to administration.
The client is obliged to pay GMP+ INTERNATIONAL fees according to actual tariff.
Commercial arrangements are detailed in contracts or other agreements between URS and the clients or clients.

Structural Changes to Systems and Organisations
All clients are required to keep their system documentation up-to-date and to notify the Scheme Manager of URS of any significant changes to the organisation’s systems or structure. In particular any changes which may affect the scope of certification or which result in a new appointment to the position of Representative must be reported. URS’s auditors must be notified of all changes made to the management system since the previous visit.

Disputes
Any disputes subject to legal proceedings will be settled in accordance with law of EU (European Union).

ТОВ "ЮНАЙТЕД РЕГІСТР ОФ СИСТЕМС УКРАЇНА"
вул. Водогінна 2, оф 221
79011, Львів

+38 067 364 52 00
+38 050 603 74 88
+38 032 244 48 80
 

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Certification of Systems
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