Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 10
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21The Investigations Operations Manual (IOM) Chapter 4, Subchapter 4.5.4 Official Seals,
discusses the following:
•
application of official seals,
•
sealing methods,
•
protecting the official seals,
•
broken official seals and temporary seals, and
•
metal seals.
The seal is initialed and dated in ink in the space provided and, when possible, is broken
across the section showing the sample number, date, and signature. In the designated area
at one end of the paper seal, it is initialed and dated in ink by the analyst and broken
across the section showing the sample number, date and signature of the Collector. It is
acceptable to break the paper seal in another location, if necessary. See IOM Exhibit 4-
17. When breaking a metal seal, a sharp metal tool is used to scratch initials and date on
the seal.
Generally, original seals are not to be removed from the sample package. If removed, the
broken seal is submitted with the Analyst Worksheet as an attachment, and the fact the
original seal is submitted is quoted on the Analyst Worksheet, Item 11, Reserve Sample.
The entire seal, with the investigator’s inscription, analyst’s initials, and dates, easily
visible, are attached to mounting paper. The mounting paper is identified with the
Attachment number, sample number, date, and initials in the upper right corner. See
ORA Laboratory Manual, Volume III, Section 3.3, Completing Worksheets and
Continuation Sheets.
2.4.2.2 Opening the Package and Inspecting the Sample
After breaking the Official Seal (if present) and opening the package, the analyst removes
and inspects the sample.
Using the Laboratory’s “Complaint/Corrective Action” Procedure, the analyst documents
any discernible abnormalities, discrepancies, and problems such as the following:
•
discrepancies between the sample received from the sample described in
the FACTS “Collection Report” or any other record,
•
broken paper seals without initials or date in the designated area,
•
damaged sample or sample package,
•
records failing to describe type of analysis requested, and
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 10 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
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