Evidence binder summary

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  • Publicado : 4 de septiembre de 2012
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The evidence presented herein covers the scope as defined in the revision to the Errata, submitted on July 27, 2012 to the Workplan Numbered Step LP-09-FE-06-A. The Packaging Lines under the scopefor the “In-Use” verification are:
• Bottle Packaging Line 31
• Bottle Packaging Line 2
• Bottle Packaging Line 5
• Bottle Packaging Line 9
• Bottle Packaging Line 10
The evidence presentedsupports the “In-Use” phase of the processes, standard operating procedures and controls for the use of the Optel Vision Inspection System in the filling stations for the bottle packaging lines at McNeilHealthcare LLC Las Piedras Site.
The following packaging lines are out of the scope of this Numbered Step as per revision to the Errata are:
• Blister Packaging Line 7
• Blister Packaging Line 12
•Blister Packaging Line 14
The following packaging lines will remain out of scope as per Errata to the Workplan submitted on June 6, 2012.
• Bottle Packaging Line 6
• Blister Packaging Line 11Note: Refer to the revision to the Errata, submitted on July 27, 2012 and to the original Errata submitted on June 6, 2012 for complete rationale for the packaging lines out of the scope of this NumberedStep and for the requirements of the packaging lines is to be reactivated.
Background:
As required by the Consent Decree of Permanent Injunction entered into on March 16, 2011 between the UnitedStates of America and McNeil-PPC, Inc (McNeil), McNeil is submitting this Evidence Binder to provide documented evidence for the confirmation of “In-Use” activities related to Lettered Step LP-09-FE-06-Aas stipulated in the Workplan for the Las Piedras, Puerto Rico, site submitted on October 21, 2011 and Erratas submitted on June 6, 2012 and revision on July 27, 2012.
The Workplan stipulates thefollowing for Lettered Step LP-09-FE-06-A:
- Install and Modify packaging equipment to improve mix-up detection & mitigation as referenced in CAP Section 5.
A. Installation of...
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