Annex VI Just in Time or Small Batch Production

Annex VI: Just in Time or Small Batch Production

Annex VI Just in Time or Small Batch ProductionThe imminence of Annex VI will have a resounding impact upon the clinical trial industry, adding further complexity to the existing compliance legislation. As the clinical trials industry adapts its approach towards production and supply, I will discuss the differences between Just in Time and Small Batch Production from a labeling perspective and the Importance of a sophisticated streamlined software solution for this.

A key issue caused by Annex VI is the requirement for period of use on inner packaging and the fact that this is liable to change after labeling and before use. Small Batch Production and Just in Time are ways to mitigate this issue.

Small Batch Production benefits:
Small Batch Production is an approach to production and supply that may be useful during times of uncertainty. It is a type of production that focusses upon producing smaller but more frequent batches of primary packaging.

  • This approach does not require any changes to the existing process of production.
    Secondly, because of smaller volume, this approach minimizes the risk of information, particularly period of use, displayed on the packaging becoming out of date.
  • Thirdly, because pressure in mass volume is alleviated from the production process it can improve stock fluidity and improve inventory turnover.

Just in Time benefits:
Small Batch Production is sometimes incorrectly referred to as Just in Time and whilst both possess similarities regarding their impact, they are both different approaches to production and supply. Just in Time is an approach whereby printing, packing and shipping are completed in accordance with a pre-existing plan using the latest approved data.

  • JIT utilises the latest data and so greatly decreases the likelihood that integral information such as expiry dates will become out of date before the product is used. This in turn reduces the need to not only change inner and outer packaging but also the flexibility to adapt to any design changes or regulatory fluctuation. This capability is essential regarding Annex VI.
  • This approach can also improve inventory turnover because levels of stock are kept to a bare minimum.

PRISYM 360: Just in Time Labeling
The practicalities of success with JIT depend on many factors including the use of a solution like PRISYM 360 that can reduce overheads and risk in production, by using the latest approved data to calculate expiry dates. It is important to be prepared during times of uncertainty. The strategy of waiting to analyse what competitors or partners do is risky as it takes time to integrate a new system. Be smart. Partner with labeling solution experts like us, to ensure you are prepared for the forthcoming.

How we can help with Annex VI

Gordon Alexander

About the author

Gordon Alexander, Enterprise Pre-sales Engineering, PRISYM ID

Gordon is involved in understanding customer needs and industry challenges to drive solutions to improve efficiency, minimize risk, address regulatory requirements and provide new approaches to business systems and processes. Gordon has 20 years of technical software experience with roles as industry consultant, business analyst, and pre-sales engineering.