Technical Agreement Template

The terms of this Agreement shall be governed by the laws of [Consultant.State]. All disputes or legal proceedings are filed and settled by a neutral arbitrator in [Consultant.State]. If an advisor and a client come into conflict, both parties agree that the winning party shall reimburse its entire attorney`s fees, including attorneys` fees, by the opposing party. This Agreement represents the entirety of the terms and conditions between the Consultant and the Client with respect to the services described therein. Any addition or modification of this Agreement is subject to the written agreement of both parties. If both agreements contain provisions relating to the same subject-matter, these must be carefully examined in the event that one of the agreements is subsequently amended. Make sure that your technical agreement contains all the cGMP rules applicable to the manufacture of a particular product. – active and adjuvant-bound raw materials must be purchased in accordance with the `Guidelines to minimise the risk of transfer`. – The Contractor may not make any changes to the process, raw materials or wording without the prior written consent of the Contractor.- Contractors and regulatory authorities should be allowed to carry out audits and inspections of the relevant processes. Premises and documents. – the contractor may not sub-assign any of its responsibilities to third parties without the agreement of the contracting entity. – Record deviations from predefined procedures or desired test results.- It is the contractor`s responsibility to keep batch records for a set period after the product expires.

Either party may terminate the agreement at any time by inculcating the other party in writing with the other party for 30 days by registered letter or email. Even in the event of cancellation, the client is responsible for pro-rated payment from the advisor for consulting services provided prior to the cancellation date. By defining a clear technical agreement, both sides know who is responsible for what, thus avoiding conflicts and have defined a clear path of escalation. During the MHRA or FDA inspection of the contract site, the inspectors` main question is how the parties share responsibility, communicate and confirm GMP compliance. With a well-written technical agreement, the contract manufacturer has a prefabricated response to the investigator. It is therefore important to learn how to establish a GMP technical agreement. It is customary for the trade agreement and the quality agreement to contain provisions relating to the same subject matter, for example.B. audit rights or technology transfer.

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