Packaging represents a critical manufacturing operation requiring strong GMPs and quality oversight to ensure sustained and
robust compliance. Historically, inadequate packaging practices have been a meaningful ongoing contributor to product recall
actions industry-wide. A strong understanding of the compliance risks associated with product packaging is a necessary and
important component of a good quality system.
This case study on packaging line GMP optimization is the sixth of eight in a series put together by the Product Quality Research
Institute Manufacturing Technical Committee (PQRI–MTC) risk-management working group. The series is meant to advance the understanding
and application of the International Conference on Harmonization (ICH) Q9 Quality Risk Management guideline by providing actual examples of risk-management assessments used by the bio/pharmaceutical industry.
The introductory article and first case study, on defining design space, appeared in the July 2011 issue of Pharmaceutical Technology (1). Subsequent case studies in the series (8 in total) can be viewed online at http://PharmTech.com/PQRIstudies.
In this case study, the authoring firm has enjoyed satisfactory compliance performance across their international packaging
operations. Nonetheless, recognizing the criticality that packaging plays in ongoing quality assurance, the firm engaged in
a risk-assessment of a number of established packaging lines at several key packaging sites worldwide. The goal of the assessment
was to further enhance the quality assurance of existing packaging operations and practices.
The risk question and risk-assessment method
The risk question developed for the subject case study is: What processes, procedures, and/or events during the packaging of a product create an unacceptable risk, real or perceived,
to the quality of that product as received by our customers?
The project team assigned to this initiative sought to find a method that was inductive, systematic, and comprehensive, with
the understanding that the risk factors for this application were generally well defined and quantitative. The risk tool selected
to perform the analysis was: functional failures and effects analysis (FFEA). This tool represents a hybrid of failure modes
and effects analysis, or FMEA, and uses a risk matrix instead of a risk priority number (RPN). FFEA is a systematic, function-based
method for examining the effects of functional failures on system performance.
In this case study, a team of subject-matter experts conducted the analysis by identifying and assessing the effects on a
system associated with individual functional failures. To apply risk-based, decision-making concepts to the FFEA, the team
also identified the frequency of each functional failure and the severity of the potential effect (outcome) and compared each
to predetermined risk-acceptance criteria. The team suggested corrective actions when required by the risk-acceptance criteria
or when the team identified opportunities for improvement.
