Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-001.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Handling of Sampled Material/Product
1.1 PurPose
To provide written instructions to clarify the steps followed after sampling till the sample reaches
the analyst.
1.2 resPonsibility
It is the responsibility of the quality assurance (QA) inspector and quality control (QC) administra-
tion to follow the procedure. QC/QA directors will be responsible for the standard operating
procedures (SOP) compliance.
1.3 Procedure
Just after sampling of raw/packaging materials or products (intermediate, bulk, or finished), sampled
items are sent to the QC laboratory for further analysis.
• The QA inspector will then enter information regarding the products' (intermediate, bulk,
or finished) raw and packaging material in the relevant log book.
• The QA inspector will further forward the samples to the QC laboratory together with
relevant documents such as sampling and receiving reports for raw and packaging material,
and batch records for intermediate, bulk, or finished products also with sampling report.
• The QC sample receiving personnel will verify samples and documents and will enter the
sample information in a relevant analysis journal.
• The receiving personnel will then assign a QC number for each sample and distribute
samples to relevant sections of the laboratory supervisor or officer (physical, chemical,
and/or microbiological) as per the material/product analytical specification.
For not more than one hour should the samples stay in the receiving room before they reach the
corresponding QC supervisor or officer.
1.4 reason for revision
First time issued for your company, affiliates, and contract manufacturers.
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