1.0
PURPOSE
To lay down the procedure for powder processing batch analysis.
2.0
SCOPE
2.1
3.0
4.0
RESPONSIBILITY
3.1
Assistant- Quality Assurance
3.2
Assistant- Quality Control
ACCOUNTABILITY
4.1
5.0
This procedure is applicable in Quality Assurance, Quality Control, producton
and Warehouse.
Manager – QA & RA
PROCEDURE
5.1
The batch numbering system for any production batch is as per SOP Assigning
Batch Number, Manufacturing and Re-Test / Expiry Dates For Active
Pharmaceutical Ingredients And Intermediates.
5.2
The following powder processing operations may be performed on batch
materials
a
Milling
b
Micronising
c
Sieving
d
Compacting
e
Blending
5.3
For blending operations (e) the batch shall be numbered as per SOP Assigning
Batch Number, Manufacturing and Re-Test / Expiry Dates For Active
Pharmaceutical Ingredients And Intermediates.
5.4
For powder processing operations a to d, the following procedure shall be
followed.
5.5
Production personnel shall transfer the total batch to warehouse after release as
per SOP Batch Release.
5.6
On receipt of an order or requirement for powder processing, production manager
shall raise requisition for powder processing BPCR to QA.
5.7
QA shall issue the BPCR with the same batch number.
5.8
Warehouse shall issue the required quantity of material for powder processing as
mentioned in the material request attached to the BPCR.
5.9
Production shall perform the operations and record the observations in the BPCR.
5.10
After completion of the operations, production shall forward the BPCR along with
sampling request slip to QA.
5.11
QA shall forward, the sampling request slip to QC and initiate review of the
BPCR
5.12
QC chemist shall allocate new A R No. for the material and issue the analytical
protocol
5.13
QC chemist shall sample the material and preserve the control sample as per
finished product sampling Product Recall.
5.14
QC chemist shall perform Identification (by IR), critical tests as per analytical
equivalence chart and powder processing specifications, e.g. particle size, sieve
analysis, bulk density, etc.
5.15
QC chemist shall refer the original analytical data of the batch and refer the data
to the original A R No. in the protocol.
5.16
QC chemist / executive shall review the analytical equivalence chart, data of test
performed (Identification, critical tests and powder processing tests) and compile
the COA.
5.17
If the material is meeting the requirements, the material release note is signed and
forwarded to QA.
5.18
Manager – QA & RA shall review the BPCR, analytical data and release the
material as per SOP Batch Release
END OF DOCUMENT