Ask our Experts GMP-compliant documentation: Handling of glued-in printouts

7 min. reading time | by Doris Borchert, Phd
Published in LOGFILE 28/2020

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:

"Printouts must be labelled properly to ensure they can be clearly assigned. Attached printouts must be marked by an employee in such a way that their initials are half on the printout and half on the paper that the printout is attached to.“

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:

"The topic arose during a supplier audit, where glued scale printouts were found in the batch documentation, which were only signed directly on the printout.

Since no requirement from a guideline could be found for this, this could not even be enforced as a "recommendation", because theoretically there is no deviation from a requirement here.

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. “

Tip from the editors:

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 Adviser, the most comprehensive GMP online knowledge portal worldwide!
There you will also learn in Chapter 15 Documentation how to put these requirements into practice.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de