Polaris

SOP# SITE-001.0CompanyEffective Date: DD/MMM/YYD. Distribution of SOPs1. Each department will maintain an active SOP manual containing authorizedcopies of all current approved SOPs.2. QA will retrieve or discard all distributed versions of the SOPs (i.e., not thearchive copy) as new versions are implemented.E. Maintaining Original, Signed SOPs1. QA will maintain a complete collection of current Company SOPs and will retainall obsolete, discontinued, or otherwise superseded SOPs in an SOP archive.F. Revision of SOPs1. SOPs requiring permanent modifications will be revised by the Author orindividual designated by the Department Head. Revised SOPs will be circulatedfor review and approval as described in Section III.C.2. QA will update the cover page of the revised SOP to show subsequent revisionsof the SOP.G. Periodic Review of SOPs1. All SOPs will be reviewed on an annual basis to determine whether modificationsare needed or if the SOP remains in use. Annual review of SOPs will be initiatedby QA. QA will issue a reminder that SOPs are due for review.2. If a procedure is no longer in use, the SOP will be considered inactive and storedby QA in the SOP archives.3. Changes to the SOP will be made according to procedures described inSection III.C.4. Documentation of annual SOP review will be maintained in the SOP archives.IV.ReferencesNoneV. AttachmentsNoneSITE-001.doc© 2004 by CRC Press LLC