A text excerpt from a sample SOP for GMP-compliant documentation of the GMP Compliance Adviser raised the question of a regulatory reference for the following section:
Editor Doris Borchert has taken over the answer to this interesting question. She does not assume that this requirement can be found literally in a GMP regulation. Rather, it can be derived from the general GMP requirements for good documentation practice:
Data must be clearly attributable - i.e. in this case, printouts and copies must be clearly labelled.
It must be ensured that the data is reliable.
In the case of glued-in printouts, this can only be ensured if the signature is applied in such a way that it covers the attached receipt and the underlying sheet.
Otherwise you could have inserted or exchanged the glued-in document afterwards. It is therefore less a detailed, literal requirement from the regulations than an interpretation or implementation in practice.
Since GMP regulations are rather general and answer the question "What is required", it is common practice to describe the implementation, and thus the "How must it be done?" in SOPs. Therefore, not every requirement in an SOP can be referenced literally to an underlying regulation.
This reply was supplemented by further information on the facts of the case from the client side:
In order to obtain an official point of view that can be used as an effective argumentation aid in the future, the question was additionally forwarded to a GMP inspector. Here is her statement:
"As a concrete reference in such cases, we often refer to sections 4.8 and 4.9 of Chapter 4 Documentation of the EU GMP Guide:
4.8 Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.
4.9 Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
The EU GMP Guide requires that changes to original entries are traceable. If the signature were not half on and half next to the printout, a subsequent change (removal/replacement of the printout) would not be traceable. “
Here you will find all the important requirements for good documentation practice:
EU GMP Guideline, Chapter 4 Documentation
WHO Guideline on Good Practice for Data and Record Management (Technical Report Series, No. 996 (2016), Annex 5)
By the way, you will find all regulations mentioned in the GMP Compliance Advisor, the most comprehensive GMP online knowledge portal worldwide!
There you will also learn in Chapter 15 Documentation how to put these requirements into practice.
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