Who has to sign a URS?

The URS (User Requirement Specification) is a key document in the qualification process and represents an important element in the life cycle of a GMP-relevant system. The question that repeatedly arises is: Who has to sign the URS? Approval by Quality Assurance (QA) is often also considered in this context.

The EU GMP regulations do not specify who has to sign a document. However, according to §10 of the German AMWHV (Medicinal Products and Active Ingredients Manufacturing Ordinance), a pharmaceutical company must determine which documents are to be approved by which parties, including possible QA approvals.

With regard to the URS, there is at least one indirect reference in the glossary of EU GMP Annex 15: The URS is defined there as "the set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system." From this, it can be inferred that the system owner, user, and engineering departments are responsible for the content of this document, and would typically be the ones to sign it. As a general rule, the following roles are required: creator, reviewer, and approver. The creator should have some understanding of how the system is used (in accordance with Annex 15 of the User). This could be a foreman or another employee who operates or works with the system. Someone who understands the technology, like the operations engineer, could be the reviewer (technology). The head of manufacturing is the system owner and approver. There is no explicit GMP requirement for QA to sign the URS in Europe-however, it is common practice for quality assurance to at least co-approve a URS.

One way of integrating QA into the approval process without delay is suggested in the ECA "Good Practice Guide Qualification & Validation". It suggests that QA is responsible for the "Quality Risk Assessment" QRA 1, among other things. According to this, QA reviews and releases the URS in a separate work step/document. This approach has the advantage that QA release takes place at the same time as the suppliers prepare their bids (which means that the bidding process can be completed more quickly). QA can also limit the scope of the URS review to critical aspects (CQA, CPP), which generally reduces the amount of work involved.

In the USA, QA approval is more strongly established. For companies that are subject to FDA regulations, the principle of "last signature QA" applies, i.e., no final release without the signature of the quality assurance department.