Unique Identification on Primary Containers to Drive Product Traceability & Quality

Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines. The most common processes and technologies applied to achieve compliance are now reaching their technical limitations and as such, new approaches are needed to deliver the traceability requirements.

Traceability at the individual container level could become very important to drive patient safety through the prevention of product mix-up. There are other strong business drivers for uniquely coded containers. These include improved batch visibility and accountability while simplifying investigation work in the case of potential deviations during fill and finish operations. This reduces risk and can limit the direct financial impact from missed revenue or drug shortages.

The purpose of this document is to obtain feedback from practitioners on the issues and challenges that may be faced if and when uniquely identified primary containers for parenteral products are implemented within their manufacturing operations. In addition, we are seeking feedback on the proposed technologies and solutions described in this document as well as any additional use cases.

This ISPE Discussion Paper outlines:

• The rationale behind the development of parenteral containers with a unique identity
• Feedback from a survey of industry related to considerations necessary to help build a business case
• The current state of implementation of unique container identification technology in parenteral manufacturing lines including potential solutions
• A summary of challenges/questions that the technology developers face to finalize and develop the robustness of the solution

A process has been developed that delivers individual identification of primary glass containers for parenteral drugs. This technology has been extensively tested at a Proof of Concept level and is now moving into the Industrialization Phase.

In parallel to the development of the technical solution, the value proposition and the business case have been created for a range of pharmaceutical products from vaccines to biologics. Furthermore, this approach has been validated by a cross section of pharmaceutical manufacturers, presenting a compelling business case.

The development of this Discussion Paper has involved representatives from a cross section of stakeholders within the pharmaceutical industry. The objectives were to provide a better understanding of the requirements for the use and implementation of uniquely identified containers in the pharmaceutical manufacturing of parenteral products. Secondly, to deliver a discussion document that can form the basis of an implementation standard for use by the industry.