1.0.
OBJECTIVE:
To describe procedure for
sampling during manufacturing process for analysis to meets its predetermined
specifications.
2.0.
SCOPE:
This procedure is applicable for
collection and submitting the samples to QC department for analysis at company -
location.
3.0.
RESPONSIBILITY:
3.1.
QA Officer/ Executive shall be
responsible for collecting the sample.
3.2.
QA Manager shall be accountable for the procedure.
4.0.
PROCEDURE:
4.1.
GENERAL :
4.1.1.
Production personnel shall intimate to QA for sampling through
Test Request after completion of the process steps.
4.1.2.
QA personnel shall sample the product as per sampling plan as
define in step no. 4.5.
4.2.
PERSONNEL HYGIENE :
4.2.1.
Personnel should have wear complete over gowning, latex hand
gloves, breathing air system and safety specs prior to sampling.
4.2.2.
Sanitize hands with 70% IPA.
4.3.
SAMPLING TOOL :
4.3.1.
Sampling tool i.e. sampling rod, spatula, and pipette should be
clean prior sampling.
4.4.
LABELING :
4.4.1.
After sampling QA will affix ‘Under Test label’ on the
container(s) / Vessel and make necessary entry in the register and then send
the sample in proper manner with Test Request and register to QC laboratory for
analysis of the sample.
4.5.
SAMPLING PLAN :
|
Tablet
|
Ointment
/ Cream / Gel
|
||
|
Stage
|
Sample
Qty.
|
Stage
|
Sample
Qty.
|
|
Granulation
|
10
g
|
Mixing
|
Eq.
about 4 units qty.
|
|
Compression
|
160
tab*
|
Filling
|
10
units**
|
|
Coating
|
50
tab*
|
* Collect 25
units from LHS & RHS during processing of batch. And after completion of
processing make composite sample from the collected units during processing.
** Sampled
from each container and if containers more than 10, then apply √ n + 1 sampling plan.
|
|
4.6.
TABLET MANUFACTURING :
4.6.1.
GRANULATION :
4.6.1.1.On sampling intimation through ‘Test
Request’ from production, QA will sampled the granules from FBP/ Blender
through sampling rod, after completion of final mixing / lubrication stage.
4.6.1.2.After sampling keep the granules in to the
sampling bag with “SAMPLE FOR ANALYSIS” label on it.
4.6.1.3.After sampling Affix ‘under Test’ label on
the equipment contained granules.
4.6.1.4.Then he / she will make proper entry in to
the sample register and send the sample to QC laboratory in proper manner.
4.6.1.5.This is Bulk sample.
4.6.2.
COMPRESSION :
4.6.2.1.During running of compression machine,
collect 25 tablets each of LHS & RHS of compression machine.
4.6.2.2.After Completion of the Compression process
make composite sample (50tablets) from the collected tablets.
4.6.2.3.Keep the samples in to the poly bag with
“SAMPLE FOR ANALYSIS” label on it.
4.6.2.4.Then affix ‘Under Test’ label on the
container(s).
4.6.2.5.Make appropriate entry in to the sample
register and then send the sample to QC Laboratory.
4.6.2.6.This is Final sample if the final product
is in Uncoated form (Finished Product).
4.6.2.7.This is Intermediate sample if the final
product is in coated form.
4.6.3.
COATING :
4.6.3.1.On
sampling intimation from production through ‘Test Request’, collect randomly 50
tablets for each drum / lot in such a way so as to ensure that sampled quantity
represents the entire coating lot.
4.6.3.2.Check
the uniformity of coating and shade variation.
4.6.3.3.Keep
the samples in to the poly bag with “SAMPLE FOR ANALYSIS” label on it.
4.6.3.4.Then
make appropriate entry in to the sample register and send the sample to QC
laboratory.
4.6.3.5.This is Final sample (Finished Product).
5.0.
ANNEXURE:
Annexure-I :
Label format for “SAMPLE FOR ANALYSIS”
6.0.
REFERENCES:
Nil
7.0.
ABBREVIATION :
Abbreviation used Full form of abbreviation used
QA Quality
Assurance
No. Number
% Percentage
IPA Isopropyl
Alcohol
QC Quality
Control
Qty. Quantity
gm Gram
SOP Standard
Operating Procedure
LHS Left
Hand Side
RHS Right
Hand Side
Hrs. Hours
8.0.
DISTRIBUTED TO:
Quality
Assurance
Manufacturing
Quality Control
9.0.
REVISION HISTORY:
|
Revision
|
Change
Control Number
|
Reason for the
Modifications
|
|
|
|
|
Annexure-I :
Label format for “SAMPLE FOR ANALYSIS”
|
Company
|
|
|
Sample For Analysis (Label)
|
|
|
Name of
Product:
|
|
|
Batch No.:
|
|
|
Mfg. Date :
|
|
|
Stage :
|
|
|
Sample Qty. :
|
|
|
Sampled By
(Sign & Date):
|
|
|
Ref QAD-010-F01-02
|
|
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