In my recent set of blogs, I have been talking about the need for and benefits of proof reading in the review and approval of artwork. In this article, I will highlight the need to train the staff involved, talk about the difficulties of covering all reviewers in the company network and what training opportunities are available.
Reviewing artwork – a GMP activity
The regulatory authorities in the US and EU and other authorities require management to have systems to ensure patient safety on labelling. The FDA CFR 211.125 insists strict control shall be exercised over labelling issued in drug product labelling operations. In CFR 820.30 for medical devices, the FDA says any changes to labelling must be formally reviewed and authorised before implementation. The MHRA have issued guidelines on best practice for the design of labelling and in EC GMP guide part 1 they talk about QA principles regarding labelling. These are only principles but they look for responsibility and active management by senior management, all quality-related activities are defined and documented, responsibilities are defined (in writing) and release of material only occurs after controls are completed.
Review and approval of artwork is a GMP activity so it is important that procedures are in place, staff are trained, assessed and the results documented in their training records. If you are audited tomorrow, are you confident your company would be in compliance for all staff involved in your labelling and artwork process?
The difficulty of training all the reviewers in your company network
I generally find the central regulatory and artwork groups have very detailed procedures. It can be a very different story with the affiliates. Even where procedures exist, and often they don’t, it is usually a very ‘thin’ procedure which doesn’t detail the specific responsibilities of the affiliate reviewer. ‘Training’ often is just a request to read the SOP and there is no assessment prior to permission to undertake these GMP tasks. In addition, affiliate reviewers are often changing making it difficult to remain in compliance.
It is key, however, that a native speaker who knows what is registered locally reviews the artwork correctly, and management must consider this group, as well as the central group, when looking at training and compliance. All reviewer groups must be trained, assessed, and details documented in training records.
Training opportunities for proof readers and reviewers
In most cases, I would recommend the reviewers have role-specific checklists within SOPs and are trained to understand what documentation they need before they begin a review, what specifically they are checking and, importantly, how to check that particular element. As proof readers undertake a broader range of checks, their training must encompass all of these activities, hence is even more comprehensive.
Unfortunately we find sourcing suitable training is a challenge and often limited to Company SOP training or guidance from other reviewers or proof readers. At Be4ward we have looked to help fill this training gap. Please refer to the attached link for more information on proof reading training, applicable to anyone involved in the review and approval of artwork in your company.
In my next article, I will look at the importance of measuring your artwork service.
To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.
For more information on artwork, go to our free download section.