GAMP Audit Checklist

Audit details (address, audit team, supplier representatives) 

Company size, structure and summary of history (number of sites, staff, organizational charts, company history) 

Product/service history (main markets, how many sold, use in pharmaceutical sector) 

Summary of product/service under audit (product literature) 

Tour of facility (to verify housekeeping, general working environment, working conditions) 

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Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Reference procedure to be followed Reference Checklist used to guide audit (e.g., GAMP)... 

Unless the supplier in question has already been accredited (better yet, proven) as a preferred supplier, a formal Supplier Audit is an essential prerequisite. Smaller blood establishments may choose to delegate a trusted third party to carry out an audit on their behalf. In all cases, a comprehensive checklist of the type outlined in Appendix M2 of GAMP 4 should be used. 

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