In Europe, the Qualified Person is responsible for ensuring that the legal requirements for manufacturing and testing medicinal products are met. The management of the contract giver must provide the resources that the Qualified Person requires to carry out his or her tasks in accordance with the legal requirements that apply to medicinal products. He/she may delegate tasks, especially to the Head of Production and Head of Quality Control, or to other Qualified Persons working as subcontractors.
However, the Qualified Person who signs the approval for the marketing of the medicinal product is responsible for ensuring that the medicinal product is manufactured and tested in accordance with the statutory regulations and the marketing authorisation or clinical trial authorisation. He/she must ensure that the contract giver meets all of the regulations governing medicinal products, even if some of the services are outsourced.
The QA system of the contract giver must specify in detail how the Qualified Person can meet his or her responsibility. Furthermore, the contract giver's QA system must specify how the qualification of the suppliers is carried out and how their performance can be reviewed and monitored on an ongoing basis.
The basis for cooperation is an agreed contract between the contract giver and the contract accep-tor that defines the assignment of tasks and distribution of responsibilities between the companies involved (liability limiting agreement, see Chapter 1.4 Liability limiting agreement (LLA)). Before awarding contracts to suppliers, the contract giver must ensure that the contract meets the legal requirements, that the contract acceptor is capable of carrying out the tasks and has the necessary equipment, competencies and staff to complete the outsourced activity without impacting the quality of the product. This also means that the contract giver must ensure that the contract acceptor complies with GMP guidelines.
Furthermore, the contract giver must provide the contract acceptor with the information and documentation that is necessary for the contract acceptor to carry out the activities in accordance with the marketing authorisation. This does not only include sharing manufacturing and testing instructions, but also informing the contract acceptor about any issues that occurred during the development stage or problems that may have occurred during manufacturing and testing in the past. In addition, it is important to provide validation and revalidation documents and, if applicable, PQR evaluations to ensure that the service can be outsourced to the service provider quickly and safely. The contract giver must also provide the contract acceptor with information about safety measures that may be pertinent. This is mandatory for medical products and substances due to their pharmacological activity and applies in particular to newly developed substances that are not commonly known.
Within the framework of a continuous supplier evaluation, the contract giver must evaluate the performance of the supplier on a regular basis and ensure that changes and modifications to existing stipulations and specifications are carried out, if they are deemed necessary. The evaluation can be riskbased and should cover different issues, for example, whether the service is outsourced on a one off basis or permanently, what kind of experience the contract giver had with the supplier in the past, in what way complaints and deviations were treated, and the evaluation of the results of the company's audits or those of the inspection authorities.
The contract giver is also responsible for examining and evaluating the documentation for the service provided. This can be carried out directly by the contract giver's Qualified Person or delegated to the contract acceptor's Qualified Person if this was contractually agreed. A risk-based approach should be taken here as well to ensure that individual documents do not have to be double-checked. Whether the contract acceptor's documentation meets the requirements of the contract giver can be verified by providing the contract giver with all of the documents for the first batches when outsourced services are carried out for the first time. Later, random controls can be carried out within the framework of regular supplier audits.
During an annual product quality review, it must be regularly proven that the contracts between the contract giver and contract acceptor are up to date.
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Managing Outsourced GMP Activities Successfully