Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-004.00 Effective date: mm/dd/yyyy
Approved by:
SUBJECT: Sampling of Bulk Products for Laboratory Testing
23.1 PurPose
To provide written instructions for the sampling of bulk products.
23.2 resPonsibility
It is the responsibility of the QAI to follow up the procedure. The QA manager will be responsible
for the SOP compliance.
23.3
Procedure
23.3.1 S
amPling
of
B
ulk
P
roductS
and
i
intermediate
P
roductS
Prerequisite: The QAI will make sure that the container is clean, sterile, dry, and pyrogen free
(as the case may be).
23.3.2 d
ry
P
roduction
: t
aBletS
and
c
aPSule
B
ulk
S
amPling
After release as per SOP QAS-000 by quality assurance, the QAI will label plastic container/plastic
bags with the sampling label and will raise a sampling report by mentioning the product's name,
code and batch number, and stage of sampling (Attachment I).
At the commencement of the compression/encapsulation, the QAI will send a sample of 50 tab-
lets/capsules with bulk release form for analysis/dissolution test from every batch.
The QAI will collect tablets/capsules in plastic container/plastic bag such that the representative
sample of the whole batch is collected and the sample size is as per the quantities required for testing
of each product.
Container/plastic bags will be sent to the quality control administration for analysis and bulk release.
23.3.2.1 Powder Prosuspension
The QAI will collect the samples after blending (or as mentioned in the product specification) in
plastic bag or bottles with the help of a sampling thief.
The QAI will prepare a sampling report making sure that the samples are properly labeled.
23.3.2.2 sampling after sealing/coating
The information for sampling will be provided by the production department on “sampling advice”
at the time of completion of sealing and coating.
The QAI will sample and prepare the sampling report, making sure that the sample is properly
labeled and the report is duly filled in.
23.3.3 S
amPling
of
S
oft
P
roductS
At the completion of bulk manufacturing, the production department will inform the QAI to collect
samples. The QAI will collect samples in glass bottles or plastic container (cream and ointment) and
will send the sample along with the sampling report to the in-process laboratory at the packaging side.
23.3.3.1 exception
Bulk sampling of suspension products for microbiological testing shall be carried out from filling lines.
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