The confusion caused by failing to use a GMP date format can be frustrating at best, and catastrophic at worst. In this blog, we highlight what can go wrong when regulated industries use inconsistent date formats, and guide you to some information to help you avoid this kind of trouble.
The problem in a nutshell
Data integrity covers not only the security of your data, but also the quality of it. Using unclear or inconsistent date formats contributes to poor-quality data, which can:
- complicate and delay analysis, as data may have to be cleansed first
- cast doubt over or even invalidate a study or trial, as data are unreliable
- result in product discards, recalls or patient harm
- draw increased scrutiny from auditors or other stakeholders
- erode a good reputation, either your own or your organisation’s.
Is there an internationally standardised GMP date format?
Professional communities in the technology, aerospace, science, and research sectors use ISO 8601(1) as their standard, to give them the precision and consistency they need to communicate effectively across international boundaries or even just within their own teams.
But outside those very specialised industries, wide variations in how dates and times are represented persist. Even within the same business, you can find a lack of consistency. For example, should you write 7:00 a.m., 7:00 am, 7:00 AM or some other variation? While that’s largely a matter of editorial style, other types of inconsistencies are more of a worry.
Consider the date 04/07/03. Does this mean the fourth of July, 2003, as it would in Australia, or the seventh of April 2003, as it would in the US? Or is it even the third of July 2004, as ISO 8601 allowed at one point?
What about the date 5/2/2017? Not only is it unclear which date is meant, but there is the potential for the five and the two to be altered to 15 or 25 and 12 or 22 respectively. Adopting a GMP date format removes the risk of misinterpretation and the potential for unauthorised alteration of single-digit dates.
What the codes of GMP say
Codes of GMP don’t tend to be prescriptive in regard to date and time formats. Rather, they give principles by which to work. The principles that relate to date and time formats in GMP environments are that they should:
- be unambiguous
- be used consistently
- minimise the risk of unauthorised alteration
- provide the level of precision required for the context in which they are used.
So there’s no single ‘correct’ GMP date format, but potentially several (and certainly some ‘incorrect’ ones). An unambiguous date format for English-speaking audiences is the 2-3-4 format: DD/MMM/YYYY, e.g. 28 Jun 2017. The 2-3-2 format: DD/MMM/YY, e.g. 28 Jun 17, is also acceptable if a system is set up to take a 2-digit year.
For time formats, you can use either the 24-hour system or the 12-hour system, as long as the abbreviations and words that support them are clearly defined and are used consistently (e.g. a.m. vs am, noon vs midday).
How to implement GMP date formats
Our partner company, PharmOut, has written a white paper on How to Implement Good Documentation Practices, including the use of GMP date formats. You can use this white paper as a basis for implementing GMP date formats in your business or as a guide in reviewing your current practices.
If you’d like more-specific guidance for your business, contact us today for an obligation-free consultation.
(1) ISO 8601 Data elements and interchange formats – Information exchange – Representation of dates and times.