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Qualification can only start after commissioning is completed. The outcome of qualification is approved documented evidence that systems operate as intended. For packaging machinery, agreed upon critical functions that have an impact on product quality are qualified (i.e., lot identification). Commissioning documentation can be referenced in qualification to eliminate duplication of checks and tests. Commissioning and qualification are completed by the project team prior to process validation. Process validation is typically completed by the system owner [such as Abbott].
Commissioning is completed by engineering and is a process of performing checks and tests, as needed, to determine whether the equipment is installed and operates as designed. The outcome of commissioning is a system that operates as designed. Please define and contrast the terms "commissioning," "qualification," and"validation" when it comes to packaging processes and machinery. When is each of these tasks done, and by whom? The benefits JETT provides can be realized across all our manufacturing operations, including packaging. Abbott has the opportunity to interact with other pharmaceutical companies to discuss practical issues related to equipment and process control qualification. We help provide the JETT team with sample documents to be utilized throughout the healthcare industry. We also have the opportunity to present these practical "how-to" solutions to industry through the ISPE, GAMP Americas, and Interphex conferences. Interacting with external peers within this industry helps us to stay current with how regulation is being interpreted and implemented. Participating may be viewed as having an outside perspective that can help project teams be more efficient. There are no fees for JETT participation. Involvement is on a volunteer basis. Describe the benefits that Abbott (and you as a professional) receive from JETT? Abbott Laboratories is a member of the JETT consortium, a GAMP (Good Automated Manufacturing Practice) Special Interest Group. JETT provides a forum to improve communications between pharmaceutical companies, OEMs, and consulting groups to streamline equipment qualification by improving documentation delivered to end users [such as Abbott]. The JETT team also offers tools and templates that align with the GAMP methodology. Abbott joined JETT shortly after the consortium was formed in June,1996. The problem facing us at that time was receiving acceptable documentation needed for validation without added cost.
