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Wooden Pallets – Ensuring Vendor Compliance – GMP in the Supply Chain

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

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Wooden Pallets – Ensuring Vendor Compliance – GMP in the Supply Chain

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  1. Wooden Pallets – Ensuring Vendor Compliance – GMP in the Supply Chain Bernie Manning, Centocor Biologics

  2. 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

  3. 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

  4. All you need to know about Pallets • Wooden pallets used for transport and storage of materials. • Treated with heat or phenols eg2,4,6, 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.

  5. 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

  6. 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

  7. 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 non-compliant pallets – develop a decision tree

  8. 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.

  9. Implementation Complete • Both Cork sites fully compliant • Chemical and Bio Risk Assessment Decision Tree finalised • Maximum1 to 2 non compliant pallets per month

  10. Questions?

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