PQRI Case Study (6): Packaging Line GMP Optimization - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

PQRI Case Study (6): Packaging Line GMP Optimization
The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.


Pharmaceutical Technology
pp. 46-48

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here