The practice of making true copies of thermal paper.
Last week I was asked an interesting question relating to making true copies of thermal paper. We all copy thermal paper but the question was: ‘Where does it say that in the regulations that this needs to be done?’
One of the challenges when training new GMP starters in good documentation practice is that regulatory guidance (for example CFRs and PIC/S GMP guidances) don’t tell us how to do something, rather they tell us what a requirement is, then the manufacturer needs to establish processes to meet the requirement.
Much of good documentation practices are extrapolations of broad compliance statements which, over time, become industry practice. If companies can demonstrate a way to meet the same requirements via a different route then this is acceptable. The practice of copying thermal paper is not explicitly stated anywhere but it is normal practice as it supports data retention and data integrity requirements.
In a very short time frame, under most conditions, record legibility on thermal paper begins to deteriorate or fade, rendering the record illegible. This is where the practice of creating true copies has evolved from.
CFR 211.180 (a) Any production, control or… record… associated with a batch of drug product shall be retained for at least one year after the expiration of the batch. The scope of this includes:
- 180(c): Records 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.’
- 184 (b): The results of any test… and the conclusions.
- 188: Batch production and control records … (5) in-process lab control results (forming part of the batch record).
The requirement is ‘record retention’ and the ability to ‘recreate’ the manufacturing and control events, therefore the legibility of the thermal print-outs becomes part of the primary batch record that needs to be retained. Industry achieves this is by creating true copies of thermal paper records.
In the FDA Inspection Records we see Thermal Paper referred to as unreliable as early as 1983.
In PIC/S we can find the requirement under the Principles in chapter 4, ‘Suitable controls should be implemented to ensure accuracy, integrity, availability and legibility of documents’ as well as under documentation retention requirements in Chapter 4.
If your company is using a type of thermal paper that does not deteriorate and the record integrity can be demonstrated by remaining legible for the retention period of the product then the practice of copying thermal paper could be stopped.
The importance of ‘why’
A different question our thermal paper friend could have asked might have been, ‘why is making true copies of thermal paper such common practice in regulated companies?’
Understanding the ‘why’ of regulations is as important as knowing ‘what’. GMP and the associated integrity of the GMP records is not about following checklists but understanding the risk to product, patient and implementing processes to mitigate and manage those risks.
Need some bed time reading on Data Integrity?
Why not read the PharmOut White paper on “How to Implement Good Documentation Practices”?
The MHRA recently published definitions on “Original record” vs a “True Copy”, read more MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015.