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Facilities Inspection
Facilities Inspections are done mainly for manufacturers of vaccines and other biologics. However, facilities inspections can be done on behalf of Governments who have manufacturers in their country.
This page is broken down into the following 3 sections: what is done on a GMP Type Inspection (Product Specific), what Documents and Data are evaluated on a site inspection, and what Manufacturing Facilities I have inspected as a carded inspector. Click on the appropriate heading above or return to the home page.
GMP Type Inspection (Product Specific)
A Facilities Inspection, specifically a GMP type inspection and On Site Evaluation (Product specific) covers ...
- Site visit to inspect the facilities and all aspects of production, validation and control; including warehouse (raw materials and finished product areas), production areas, filling and packaging areas and quality control areas including animal facilities; evaluation of QA and training programs
- Contractor/supplier audits
- Issuance of exit notice observations (deficiencies)
- Inspection report
- Recommendations to correct deficiencies
- Provide training on correction of deficiencies
- Provide training on conduct of audits and how to prepare for inspections
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Documents and Data
A site inspection includes evaluation of the following documents and data ...
- Master and Working Seed inventories - including origin of media constituents and Certificates of Origin of bovine products
- Complete process validation reports with supporting data
- Fermentation media - validation data to support sterility
- Validation data to support storage times of all in process intermediates and final bulks
- Cleaning validation program for all major equipment and supporting data
- SIP validation program for major equipment with supporting data
- Cleaning validation data for premises involved in production
- Validation data for re-use of columns, filters and membranes
- Environmental monitoring program for all areas involved in production and validation data
- Routine environmental monitoring data for all areas in production
- Preventive maintenance program for HVAC systems
- Validation of the water systems
- Routine WFI monitoring data
- Master Batch Records
- Personnel gowning program
- Training program
- Product failure list and reasons why
- Incident or deviation report program
- Validation data for analytical assays and bioassays
- Animal health certificates and animal sentinel data
- Shipping validation data
- Supplier audit program; results of raw materials and animal supplier audits
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Manufacturing Facilites
When I was a carded inspector, I conducted inspections of the following manufacturing facilities ...
- Aventis Pasteur - Lyons, France
- Aventis Pasteur - Toronto, Canada
- GlaxoSmithKline - Rixensart, Belgium
- Wyeth Ayerst - Pearl River, USA
- Wyeth Ayerst - North Carolina, USA
- Merck - West-Point, USA
- Chiron/Behring - Marburg, Germany
- Biken - Japan
- Statens Serum Institute - Copenhagen, Denmark
- Takeda - Japan
- BioChem Pharma - Laval, Canada
- Biochem Pharma - Quebec City, Canada
- Sclavo - Sienna, Italy
- Synco Biopartners - Amsterdam, Netherlands
- Allergan - Westport, Ireland
- Allergan - California, USA
- Ribi - Montana, USA
- Warner Lambert - Dublin, Ireland
- Regeneron - New York, USA
- Kyowa Hakko Kogyo - Hofu, Japan
- SBL Vaccines - Stockholm, Sweden
- SBL Vaccines - Matfors, Sweden
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