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Technical Agreement Quality Agreement
By Zach Arnold | October 10, 2021
In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. In such cases of contract manufacturing, the EU Guidelines on Good Manufacturing Practice invite companies to sign a technical agreement setting out the roles and responsibilities of the parties concerned with regard to the manufacture and control of medicinal products. A GMP technical agreement ensures compliance with current best practices (cGMP). In addition, the EU PMP directives provide that “the treaty should clearly describe who carries out each stage of the outsourced activity, for example: Knowledge management, technology transfer, supply chain, subcontracting, quality and procurement of materials, examination and release of materials, carrying out production and quality controls (including process controls, sampling and analysis”. The agreement should not contain certain points such as general terms and conditions of sale, price and escalator clauses, forecasts, delivery conditions, confidentiality obligations and limitations of liability. These positions are included in the delivery contract, which is separate proof. The quality agreement may be included by reference in the delivery agreement. If both documents are established as a single document, the whitelist may contain people who have no reason or no time to check for issues that have nothing to do with their area of expertise. After offering real examples of technical changes that didn`t seem to have an impact, but ultimately resulted in product issues or administrative notification requirements, we agreed to notify the CDMO PM to the customer`s CTO during the two-hour scheduled calls. In the project plan, we also committed to having representatives on site or during critical operations and manufacturing campaigns in order to be informed in real time of the QE. This is a constructive negotiation with the available instruments. This model master document of more than 35 pages for the manufacture of a quality technical contract clearly defines the obligations of the procuring entity and the contractor and is extremely beneficial for both parties. The proposal sets out all the provisions, agreements and controls necessary to avoid any misunderstanding that could lead to a product or work of unsatisfactory quality.
Quality assurance, with input from manufacturing and laboratory personnel from both parties, should prepare the agreement. The SQ functions of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must verify the quality agreement to ensure that its requirements are taken into account. Whenever a contractor or CMO is engaged, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be concluded. . . .
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