Transcript Document
Wooden Pallets – Ensuring Vendor Compliance – GMP in the Supply Chain Bernie Manning, Centocor Biologics Overview • Background Information • All you need to know about Pallets • 3 Steps to Compliance • Symbols that Ensure Compliance • Challenges and Solutions • Potential Questions During GMP Audits • Implementation Complete Background Information • Originated in McNeil Healthcare Facility, PA, USA • Musty odour and Taste reported from some OTC medications eg Tylenol, some gastrointestinal upset also reported • Investigation identified that the most likely cause was storage of drug containers on contaminated pallets • All potentially impacted products recalled All you need to know about Pallets • Wooden pallets used for transport and storage of materials. • Treated with heat or phenols eg 2,4,6, Tribromophenol (TBP) to remove pests • In certain conditions TBP can be converted by fungi into 2,4,6 Tribromoanisole (TBA) • TBA has a musty, mildew-type odour – recognised for years by wine industry as also causes corked wine. 3 Steps to Compliance • FDA 483 issued January 2010 and Three Phased Implementation Plan developed • Phase 1 – Global Pallet Policy issued documenting expectations – Supplier compliance program initiated • Phase 2 – 100% inspection of incoming pallets for compliance with policy – Non-compliant storage pallets removed from sites • Phase 3 – Risk assessment developed for assessing materials received on non compliant pallets – 100% worldwide compliance Symbols that Ensure Compliance • International Standard ISPM 15 – 2009 regulates wooden pallets. International Symbol: a-Trademark – the identifying symbol, logo, or name of the accredited agency b-Facility Identification – product manufacturer name, brand or assigned facility number c-Method of Treatment (HT represents Heat Treated) d-Country Code – the two letter ISO country abbreviation. Ireland is IE e-Approved International symbol for compliant wood packaging material Challenges and Solutions • Implementing a one-size-fits-all remediation plan across a Global multi-site operation – manage using single site contact per site • Remediating things you never knew about your supply chain eg movement of materials onto new pallets during transit from an approved supplier to site – also remediate your transport companies • Cross-site consistency in assessing receipts on noncompliant pallets – develop a decision tree Prepare for Questions During Audits • Standard questions asked by FDA (and potentially IMB) include: – Are you using wooden pallets? – Are they fumigated? – Is there a mold/mildew odor coming from any products packaged in bottles that were on these pallets? – Provide a list of all products with customer complaints which include nausea. Implementation Complete • Both Cork sites fully compliant • Chemical and Bio Risk Assessment Decision Tree finalised • Maximum1 to 2 non compliant pallets per month Questions?