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.
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.
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:
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.
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.
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.
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.
The interview was conducted by Doris Borchert from the GMP Compliance Adviser editorial office.
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.
Before you make a final decision, it is necessary to carry out a longer test phase.
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.
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?
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:
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.
The conclusion of a contract between the contractor and the client for the production of digital print data is imperative.
The annex to the contract should contain the price tables.
Doris Borchert, PhD
Maas & Peither AG – GMP Publishing