14.05.2019 | LOGFILE Feature 18/2019

The power of the comma, or: What do print data have to do with drug safety?

The power of the comma, or: What do print data have to do with drug safety?

6 min. reading time | by Doris Borchert


Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug itself that calls into question patient safety, but incorrect or erroneous information on the packaging. A comma on our bank statements can bring tears to our eyes or a smile on our lips.

The incorrect positioning of a comma in the indication of a dosage quantity, however, represents a serious patient risk. The figure 4.0mg on the paper "only" differs by a comma of 40mg - de facto, however, there is a factor of 10 behind it, which under certain circumstances can decide between life and death. The generation of print data and drug safety are therefore closely related. Reason enough to pay more attention to this topic!

Here you can read a short interview with Ilka Henkel and André Deister, the authors of the new chapter "GMP aspects when handling print data" in your GMP Compliance Adviser.

Ms Henkel, you write that incorrect dosage information in the past has repeatedly led to recalls. How can such mistakes be avoided?

To avoid such errors, the processes involved in creating digital print data must be carefully defined and controlled. This also applies to the release process after changes have been made.

Mr Deister, what are print data?

That's a good question! This already shows that the pharmaceutical entrepreneur as client and the printer or repro company as contractor often have little understanding for each other's interests. Unfortunately, the question "What are print data?" is not always answered the same way on both sides of the supply chain:

  • For the pharmaceutical entrepreneur, it is the contents that are placed (printed) on a packaging material in combination with the technical data, such as the punch contour, depiction of code and safety features.
  • For the printer, it is the data that has to be multiplied and, for example, efficiently placed on a print sheet.

Ms Henkel, what does this mean for print data security?

Safety is one of the most important issues in the pharmaceutical industry. The security of print data is equivalent to the security of the product. The print data generation process involves many steps: creation, modification, including change history, transfer from the data creator to the printer and back, and, of course, archiving the print data. In order to ensure print data security, each individual process step must be described and approved by the parties involved. Validations and risk assessments are essential.

Mr Deister, who is usually responsible for these processes?

In practice, the creation of print data is often carried out by external repro companies. In this case, the same requirements apply to external type studios as to packaging suppliers. It should be noted that both internal and external type studios must be audited.

Ms Henkel, in your opinion, what requirements must an external type studio meet?

The basic prerequisite is that external type studios have a high level of printing knowledge. The technical equipment should be up to date with the latest developments. The type studio should also have many years of experience in creating print data. In my opinion, an open and trusting relationship between client and contractor is indispensable.

And what steps are necessary to establish an external type studio?

First you have to define the selection criteria. Once a suitable studio has been found, a test phase follows, during which the systems should also be validated. The next step is to carry out an audit. Once everything has gone according to plan, nothing stands in the way of concluding the contract.

Ms Henkel, Mr Deister - thank you very much for this brief but informative insight into the subject of print data management!

The interview was conducted by Doris Borchert from the GMP Compliance Adviser editorial office.

Reading sample: Creation of print data by external repro houses

An excerpt from the GMP Compliance Adviser, Chapter 13.A.11.4

Selection criteria for an external type studio

First, conduct a search for the providers on the market. In this context, it is useful to examine the competence of a global activity. At least English language skills should be available for this. Ideally, the supplier should already have gained experience in an international environment, as more and more pharmaceutical companies are faced with the challenge of operating internationally.

From a technical point of view, knowledge of the different printing processes and the special features of the creation of printing documents is important. Ask to what extent this detailed knowledge is available.

The question of what capacities are available and how peak times can be managed should also not be underestimated. Larger type studios often have subsidiaries worldwide that take on subtasks or even the complete artwork creation. Decide whether this is in the interest of your company. Record this determination contractually.

Also check which data security the external provider has established as the standard and what the backup situation is like.

Don't just decide by price, see the complete package. This is your print data, which is subject to a high degree of sensitivity.

Test phase and validation of the systems

Before you make a final decision, it is necessary to carry out a longer test phase.

  • To do this, make changes to all packaging materials used in your company!
  • Contact your packaging suppliers together with the external type studio and make sure that the print data created by the external type studio can be processed!

The aim is to ensure that the print data released by the pharmaceutical company can be processed by the packaging supplier without further post-processing. This saves you the currently still common practice of releasing print data again. The effort invested in advance is worthwhile both for the client and for the contractor.

  • Be interested in the organization and also in the quality management of your provider!

In this context, the question of how quality controls are carried out is important: Do text comparison systems exist (important especially for changes to foreign-language texts), or are the checks carried out manually? Are control systems validated or are the results of the validation taken over by the manufacturer of the control systems?

  • Test carefully and perform multiple series of tests!

Auditing of the type studio

As described above, external type studios are subject to the same audit requirements as packaging suppliers. It is recommended to pay particular attention to the existence of the following systems and to check their functionality in the audit:

  • Quality assurance system / quality management system
  • Management system of the top management
  • Qualification and training programme for personnel
  • Documentation system
  • Change management
  • Validation and qualification
  • Product and process descriptions
  • Process description for reworking
  • CAPA system
  • Security description of electronic data management

If the contractor allows it, a look at complaints from other companies is often informative.

Give high priority to the performance of an audit and its follow-up. Ensure that the audit is conducted by experienced auditors who have detailed knowledge of the processes.

Conclusion of a contract for the production of print documents

The conclusion of a contract between the contractor and the client for the production of digital print data is imperative.

  • Describe the tasks to be performed in detail.
  • Clearly define the ownership of the digital print data. In case you want to change the type studio at a later date or establish further type studios, this is a very important specification. In any case, the pharmaceutical company must be the owner of the print data.
  • Specify that print data must be denied access by third parties and may not be passed on to third parties.
  • Define the usage rights.
  • Describe processing times for changes and specify which actions should be taken if the processing time is exceeded.
  • Clearly define the specifications for defect claims and the liability procedure.

The annex to the contract should contain the price tables.

This text is an excerpt from the GMP Compliance Adviser, Chapter 13.A.11.4

Doris Borchert


Doris Borchert, PhD
Senior GMP expert and editor-in-chief at GMP-Verlag Peither AG
E-Mail: doris.borchert@gmp-publishing.com