Quality Agreement for Clinical Trial

Examples of application by the FDA have occurred when a quality agreement has not been followed or a problem has arisen because there was no agreement and gaps have arisen. As part of a quality system, the manufacturer must ensure that the contracting company is qualified following due diligence before signing an agreement with the company. According to data collected through a 2011 Avoca sector survey of sponsoring organizations, only about 65% of respondents had quality agreements with their CROs. However, in the same survey, 94% of respondents who used a quality agreement were satisfied with the performance of their CRO, while only 59% of respondents who did not use a quality agreement were satisfied with the performance of their CRO. This supports the idea that entering into a quality agreement is essential to establishing a strong relationship between the sponsor and the CRO. Minsk shared part of the FDA`s quality agreement guideline, which included important points that needed to be strengthened (Figure 1). A formal corporate policy document should clearly state which types of suppliers and services require a quality agreement. Whenever a CMO/contractor is used, a quality agreement must be concluded. A quality agreement should exist with all suppliers of critical materials and is also recommended for suppliers of large quantities, para. B example methylcellulose for capsules, column resins, etc. There is a misconception that quality agreements are only required for the use of collective management organisations operating in a different regulatory environment. This is not the case – any outsourcing contract should have an associated quality agreement, including agreements between different departments of the same company, regardless of the physical location of one of the parties involved. There are regulatory requirements for quality agreements.

==References=====External links===GMP for pharmaceuticals, it is very likely that they will be soon. In 2016, the FDA released the guidance document “Contract Manufacturing Agreements for Drugs: Quality Agreements.” Adding a quality agreement requirement to 21 CFR 211 would bring U.S. GMPs into compliance with European Union (EU) GMPs and ICH guidelines accepted by the FDA (see below). These agreements set timelines and establish responsibility and accountability. They complement the contractual obligations. Not only do they have regulatory sense to ensure compliance with GCP regulations, but they also have an economic sense and can potentially save the sponsor time and money. In their experience, quality and regulatory staff are often called in the final rounds – perhaps in the 7th or 8th round – and the sales team or business development team may have already begun negotiations and almost completed the deal. Quality and regulation are often introduced very late, although they are ultimately responsible for most of the provisions of the quality agreement. The FDA`s 2016 guidelines on contract manufacturing agreements are limited to human, veterinary, and biological drugs.

While it is specific to drugs, biologics and veterinary drugs, others, including device manufacturers, may refer to it for advice and best practices. Also note that the quality agreement must be separate or at least separable from the commercial contract, e.B. a service contract or a supply contract. As mentioned earlier, the quality agreement can be reviewed by the FDA during an inspection. Quality agreements have been used in the pharmaceutical industry for many years to describe the responsibilities assigned to suppliers who provide GMP services such as contract manufacturing, packaging and distribution. Quality agreements are just beginning to be used in clinical drug development to ensure that responsibilities are understood by both the contractor and the supplier providing GCP services. The pharmaceutical and biopharmaceutical industries are more likely to rely on quality agreements, and the FDA recognizes the importance of proper oversight and compliance. This white paper focuses on quality agreements in the world of PCBs. In today`s environment of virtual businesses and outsourced drug development, it is important to properly supervise and monitor regulators. With the publication of ICH/GCP Addendum E-6 (R2) 2016, proponents must also demonstrate adequate monitoring of CROs by suppliers, including those awarded by the ORC-SPONSORS to another party.

A quality agreement is the ideal tool to define responsibilities and expectations. A quality agreement in the context of pharmaceutical development is an agreement that is mutually negotiated and concluded between the quality departments of a sponsor (pharmaceutical companies) and their suppliers (CRO, etc.). It is intended to define responsibilities with regard to quality tasks and to help ensure the development of safe products. Contractual partnerships inevitably have problems and quality agreements ensure that they are dealt with quickly and systematically. Another example of how our quality agreement negotiations facilitated collaboration was our discussion with a CRO about the requirement to hold at least one quarterly risk management meeting to identify risks and develop mitigation plans. During this discussion, we were able to present to the CRO the use of the Failure Mode and Impact Analysis Tool (FMEA) in risk management for our studies. Both sides committed to establishing a risk management process in the quality agreement in which specific details would be discussed at future meetings. One of the many important details of quality agreements is the time windows. If a CMO wants a processing time of five days to verify a record master batch (MBR), this can be useful because there is no need to verify the data.

However, if the CMO wants five days to review a batch production record (OPI) executed, this is not appropriate in most cases. There is simply too much data that needs to be verified to be able to do a thorough job in five days. The Quality Agreement provides a means and structure to establish the parties` expectations, identify deviations from those expectations, and establish an escalation process to address/mitigate those deviations. The key to successfully negotiating the quality agreement is a clear communication of expectations between the parties and the emphasis that each party has a sense of ownership of the study through a jointly agreed language. A quality agreement clarifies exactly what is expected of both parties and who will be responsible for virtually every aspect of the project. It also identifies specific aspects of project costs and can thus save time and money. The FDA reminds industry that quality agreements must be available for review by the agency when the agency conducts inspections. The FDA regularly requests proof of a quality agreement or lack thereof. And in ICH Q10, 2.7, “Does the pharmaceutical quality system, including the management tasks described in this section, extend to the monitoring and review of outsourced activities? The quality responsibilities of the procuring entity and the contractor should be defined in a written agreement. Those who need to know the content of the quality agreement in order to do their job should be involved in reviewing the agreement, including business development, project managers, and law (to ensure compliance with the supply agreement). The collaborative approach of creating a quality agreement creates a sense of ownership of the project by all parties involved, with the common goal of conducting a quality study.

This ensures a “win-win” situation in which both parties commit to fulfilling their responsibilities without blame and without concentrating one-way errors on the supplier because it does not meet the promoter`s standards. As a result of implementing a quality agreement, a sponsor has a study that meets their expectations, and the supplier has earned the sponsor`s trust, which hopefully leads to more successful future collaborations. CREATING A WIN-WIN SITUATION Decisive for the success of the negotiations and the implementation of the quality agreement and metrics was the involvement of the management of each company and its respective clinical and quality teams. This was important because it identified what each party considered important to conduct a quality study. On the device side, the agency can charge new 510k for the product. If it requires an application for pre-marketing authorisation, it could become a falsified product. Or you could make changes that would result in inadequate instructions for use or inadequate formulations that could also mislabel the product. Therefore, it is important that the agreement attempts to minimize this risk.

Not all changes require prior FDA approval. If you are into quality assurance, you have to deal with the “what if”. Although the quality agreement is not explicitly defined in FDA law, during an inspection, the FDA may require a review of documents describing how the contracted service provider has been managed or audited. As clinical research continues the trend of outsourcing more clinical trial activities to clinical service providers such as CROs or other providers, it is essential that sponsors ensure that the activities they outsource are conducted in accordance with the sponsor`s quality expectations. Due to shortened development times, often after a rigorous selection process, the clinical service provider immediately begins working on the project without both parties discussing their quality expectations. .