Audit Report

Corning Science JA – 809

Audit #: JA - 809
Region: Mexico
Material: Basic Chemicals/Raw Materials
Company: Corning Science
Location: Avenida Industrial del Norte S/N Reynosa
Date: 6 June 2017

This Rx-360 Audit Report contains the following scope:

The scope of the audit included:
Basic Chemicals/Raw Materials:
– Falcon Conical Tubes TM, 15 ml, sterile, Genesys no. 12050400, supplier part. no.
352097/XX2097
– Falcon Conical Tubes TM, 50 ml, sterile, Genesys no. 12050401, supplier part. no.
352098/XX2098
-Tube, 50ml, PP, sterile -Supplier part no. 430829
– Genesys Supplier part no. 12045492
Facility tour:
 Warehouse Incoming Materials incl. quarantine / reject areas / sampling areas
 Production areas, packaging/labeling processes
 QC Laboratories (IPC, Finished Goods) Warehouse Finished Goods
Quality systems:
 Procedures – Quality Policy/quality planning / Management Review
 Document Management System – records & control
 Resources – responsibilities – job descriptions
 Personnel training: planning & records (collected from selected personnel)
 Quality risk assessments / Validation Master Plan (VMP) and validation
 Change control
 Release of incoming material and final product
 QC: analytical methods / method validation / records / calibration and metrology
 Product control documentation – technical data sheets, drawings of materials & batch
records (material delivered to Roche) – line clearance (SOPs), production & process
changes – inspection and test procedures – process parameter monitoring
 Nonconformity handling (OOS procedure, deviations, CAPA, reworking)
 Environmental Monitoring: Clean Area / Room qualification & monitoring / pest
control
 Supplier qualification process / List of Approved Suppliers
 Qualification documents for external service providers (sterilization, laboratories)
 Customer complaints handling & records
The audit was based on Rx-360 Guideline for Basic Chemicals and Raw Materials, V
2.0 and the Rx-360 Supply Chain Security Checklist 2.0.