Frequent GMP Question: How many Signatures are required for Validation Protocols/ Reports?

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? What is the responsibility of the Head of Production and the QA department in this matter?

Indications can be found in the chapters 1, 2 and 4 of the EU GMP Guide Part I. You can find in Chapter 4 requirements on the topic "Documentation":

4.2. "Documents should be designed, prepared, reviewed, and distributed with care."
4.3. "Documents containing instructions should be approved, signed and dated by appropriate and authorised persons."

This can be summarized as follows: each document should have one author, one reviewer and one approver. The Head of Production is responsible for the qualification of his equipment and the validation of his processes (Chapter 2.7 (4)); the same applies to the Head of QC in the lab (2.8.).

Since the introduction of the revised Chapter 2 in February this year, a new point has been added. Moreover - depending on the size and the organisational structure of the company - an independent Head of Quality Assurance or Quality Unit can be assigned. Where such a function exists usually some of the responsibilities described in 2.6, 2.7 and 2.8 are shared with the Head of Quality Control and Head of Production. Senior management should therefore take care that roles, responsibilities, and authorities are defined. This means for example that the QA can assume the tasks of the Head of Production. Basically, the QM system should ensure that validation is performed (1.4 (10)).

Conclusion: Depending on your internal structure, you can specify the signature rules. You should be aware of what "approved" and "released" mean as both can have various meanings. "Approved" can be used for a document, for a technical review, for execution, or can even have a completely different meaning in conjunction with other terms. Similarly, depending on the term you use in combination with "released" its meaning is different, as, i.e., released formally or textually. Some companies set such definitions in a SOP documentation.

Finally, the GMP Guide gives the freedom to do it otherwise; if you - at least - come to the same conclusion and can prove it.

In the US, the procedure is slightly different. There, the personal responsibility of the Head of Production / QC is not part of the GMP regulation. On the contrary, it is the QCU who has a crucial role.

The American Society of Testing and Materials (ASTM) has a quite different approach. The document ASTM E 2500 defines "Subject Matter Experts" for qualification. According to this model, the QA department would only sign superordinate qualification documents. This is an interesting and lean approach although not very common Europe yet.

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