Service providers such as external artwork studios and printers are often used by a company to make up their full artwork capability. Where 3rd parties are used to carry out patient and product safety related activity in the end-to-end process, a company needs to ensure that any tasks that are delegated to the 3rd party are managed acceptably.
Typically, the following measures would be put in place:
- Formal 3rd party assessment and selection process managed under the company’s Quality Management System.
- Formal contracts established covering the full scope of the 3rd party’s activity.
- Critical aspects of their activity defined and agreed in some form of formal Technical Agreement.
- Critical quality standards they must adhere to defined and agreed in some form of formal Quality Agreement.
- Formal mechanism to identify and mutually agree any changes to the above.
- Formal periodic reviews of the performance of both parties in executing their duties.
- Periodic audits of the 3rd party.
All of the above points are essential to ensuring the quality of the artwork remains constant when using third part service providers.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labelling artwork management capabilities in the pharmaceutical, healthcare and other highly regulated industries. Please help me improve the thinking by adding your comments and share this with others who may have a view.
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