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An introduction to managing changes & revalidations in SBS
January 4, 2016
2 Min Read
Pharmaceutical & Medical Packaging News staff
Validating the medical device package design and packaging process for the production and distribution of terminally sterilized medical devices can be a significant investment in terms of money and resources.
The fact that EN ISO 11607 provides a means to establish product families and to use worst-case considerations to create scenarios for validations can help leverage the cost by spreading them over an entire product range. Revalidations done on a periodic basis generate additional cost and changes could require complete validations to be redone.
To optimize the effort while minimizing the risk it is important to establish at the beginning of a validation a well thought through plan and to consider potential and future revalidations building on previously documented validation efforts. This approach can have a positive impact on cost and may be essential to avoid disruptions of supply in case of short-term changes that cannot be avoided.
Guidance on design validation and process validation is widely available, but guidance on changes that require revalidation activities is relatively limited. There are basic revalidation requirements covered in the standards and in various guidance documents, but due to the general nature, interpretation can be challenging.
Therefore, when my colleague, Michael H. Scholla, Ph.D. and global director of regulatory and standards for DuPont Medical & Pharmaceutical Protection, and I decided to write an article on managing change and revalidations, we were faced with enthusiastic encouragement. The paper, "Sterile Barrier Systems: Managing Changes and Revalidations," is now available in the peer reviewed Journal of Validation Technology. It provides an overview of the regulatory requirements for sterile packaging system revalidation and covers points to consider when applying these requirements to various typical change scenarios.
We are really looking forward to comments from the community.
Thierry Wagner, Regulatory Affairs Director, EMEA DuPont Medical & Pharmaceutical Protection
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