Quality Progress - January 2014 - 64

ONE GOOD IDEA BY JOHN G. SUEDBECK Bucket List Categorize and control your risk management audit data ICH Q9 IS a U.S. Food and Drug Adminis- supplier evaluation, recalls, returns, tration standard on quality risk management complaints, deviations, out of specifica- developed by the International Conference tion results, internal audits, noncon- inspections. List all evaluations and re- on Harmonization of Technical Require- formances, change control, validation, evaluations. Include distributors because ments for Registration of Pharmaceuticals documentation, calibration and preven- they are part of the pedigree (an audit for Human Use. "Quality Risk Management" tive maintenance, product testing crite- trail that follows a drug from the time it from Annex II provides guidance for manag- ria and finished goods release. Review is manufactured through the distribution ing risk and lists risk factors to help auditors define the frequency and scope of audits.1 for adequacy and compliance. * Complexity of the site and distribu- customer surveys. * Results of previous audits and system to a pharmacy). * Major changes related to build- Auditors collect evidence during the tion. Review general site information, ing, equipment, processes and key audit process and sort evidence according pest control, holding and distribution personnel. Review the organization's to the appropriate risk factor to facilitate risk assessment mitigation planning. I like controls and security. * Complexity of the manufacturing history and change notification records. * Experience with the manufacturing to think of the factors provided in ICH Q9 process. Perform process mapping and of a product. This may include fre- as "risk buckets" for sorting data. trace the supply chain. Identify key steps quency, volume, number of batches and in the process. Verify there are adequate the percentage of the organization in the controls in place for each key step. Iden- pharmaceutical industry. The robustness tify and define quality filters in place (a of their quality management system and safeguard analysis that shows what risks the level of technology in use also may are managed and how). * Complexity of the product and its serve as evidence of their experience. * Test results of official laboratories. therapeutic significance. In descending Review pass and release testing results order of risk, review sterile finished prod- and regulatory history. ucts, nonsterile finished products, sterile A plethora of evidence often is obtained Note that reasonable conclusions are active pharmaceutical ingredients (API), from the audit process and it can become based on evidence that is sufficient, reliable nonsterile APIs with special risk factors confusing trying to make sense of it all. The and relevant. Previously, I discussed the (such as isomerisim, polymorphism or a risk factors suggested in ICH Q9 provide a reliability of audit evidence in "Solid Proof" special risk of harmful impurities), labs means of sorting the data into manageable (June 2012).2 The following is an approach and contract research organizations, non- buckets that can help your organization as- for determining the relevancy of audit sterile APIs, excipients, labels and product sess risk and manage it effectively. QP evidence as it pertains to each of the risk contact packaging. factors in ICH Q9: * Existing legal requirements. Review Also consider risk factors associated with solubility, fermentation, toxicity, nondisclosure agreements, supply agree- synthesis, impurities, solvents, chemical ments and quality agreements. activity, potency and particle size: * Overall compliance status and his- * Number and significance of qual- tory of the organization or facility. ity defects. This is the quality history Review regulatory status certifications review for the item or service. Consider and customer audit history. the development history as well. Review * Robustness of an organization's recalls, returns, complaints, deviations, quality risk management activities. out of specification results, internal audit Verify controls are in place for training, data, nonconformances and internal 64 QP * www.qualityprogress.com REFERENCE AND NOTE 1. Access ICH Q9 at www.fda.gov/downloads/ Regulatoryinformation/Guidances/ucm128053.pdf (case sensitive). 2. John G. Suedbeck, "Solid Proof," Quality Progress, June 2012, http://asq.org/quality-progress/2012/06/back-to-basics/ back-to-basics-solid-proof.html. JOHN G. SUEDBECK is a quality assurance specialist for Metrics Inc. in Greenville, NC. He earned a bachelor's degree in analytical chemistry from Fayetteville State University in North Carolina. A senior member of ASQ, Suedbeck is an ASQ-certified quality manager, quality improvement associate and quality auditor. http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm128053.pdf http://www.asq.org/quality-progress/2012/06/back-to-basics/ http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - January 2014

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
Breaking Down Barriers
Follow the Fundamentals
Fresh Perspective
Back in Service
Quality in the First Person
Career Corner
Innovation Imperative
Statistics Roundtable
Standards Outook
QP Toolbox
QP Reviews
One Good Idea

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