Copies in the GMP Environment / True Copies

Recommendation

7/8 May 2024

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Copies play an important role in the GMP environment. They are used every day. And they are a data integrity issue par excellence. Where to find references to this in the regulations?

EU GMP Guide

Looking in the EU GMP Guideline, which forms of copies are distinguished, you will find two places:

4.1 ... Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems.

Thus, the term "official copy" is used but not described or defined. Companies should describe or define the term "official copy" in their documentation system. It should be regulated how to deal with "official" copies and what value they have.

In addition, duplication of working documents is also mentioned:

4.2... The reproduction of working documents from master documents should not allow any error to be introduced through the reproduction process.

These working copies seem to be something different from official copies. Obviously, however, special attention should be paid to the copying process itself. It is up to the company to decide whether it is mandatory to distinguish between two different forms of copies.

True Copy in GMP Regulations

A frequently used term in GMP is "true copy". EU GMP does not apply this term. The term originates from the US FDA and is first used in 21 CFR Part 211:

211.180 (d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

In various guidelines on data integrity you will find definitions of the term "true copy" and numerous references.

WHO Guidance on Good Data and Record Management Practices

True copy. A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including, in the case of electronic data, all essential metadata and the original record format as appropriate.

MHRA 'GXP' Data Integrity Guidance and Definitions

A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature) to have the same information, including data that describe the context, content, and structure, as the original.

A true copy is therefore an exact, verified copy of an original record.

The WHO verifies and certifies, but does not describe what that certification should be. The MHRA is a bit more precise on this (by providing a dated signature). The PIC/S PI 041 Draft 3 devotes a separate section to the term "true copy" under 8.10.

All three guidelines (WHO, MHRA and PIC/S) also describe the handling and meaning of electronic copies of the original records (scanned variant of the original paper document as pdf file).

It is important that the company, if it wants to use the term of true copy, describes in its documentation system exactly what it understands by a true copy and how it handles it, since EU GMP does not apply the term true copy.