SOP for retesting of raw material in pharmaceutical - PharmaSOPcorner https://www.pharmasopcorner.net/2018/03/sop-for-retesting-of-raw-materi...

SOP for retesting of raw material in pharmaceutical

 Pharmasopcorner

SOP for retesting of raw materials in

pharmaceutical
1.0 Purpose:

To lay down a procedure for retesting of raw material.

2.0 Scope:

This procedure is applicable for Retesting of Raw material in Quality C ontrol

department.

3.0 Responsibility:

QC Officer/Executive/Designee :

•To enter details in retesting inward register.

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SOP for retesting of raw material in pharmaceutical - PharmaSOPcorner https://www.pharmasopcorner.net/2018/03/sop-for-retesting-of-raw-materi...

• To plan sampling and testing of retest material.

• To request for respective protocol issuance to QA.

• To maintain record of instruments usage log book.

• To issuance the approved/rejected labels.

• To prepare C OA.

• To check all the test results against the individual specification.

QC Head/ Designee :

• To review, implement and ensure compliance of SOP.

• To approve the C OA.

Warehouse Head/Designee :

• To prepare list of retest materials as per schedule.

• To inform QC department.

QA Head/ Designee :

• To approve, implement and to ensure compliance of SOP.

4.0 Procedure:

4.1 The retest date shall be allotted as follow:

MATERIAL PERIOD

Active Material - 1 Year

Inactive Solid Material - 2 Year

Inactive Liquid Material - 1 Year

C olors/Flavors - 1 Year

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SOP for retesting of raw material in pharmaceutical - PharmaSOPcorner https://www.pharmasopcorner.net/2018/03/sop-for-retesting-of-raw-materi...

Empty Hard gelatin C apsule - 1 Year

4.2 Note: If the microbial limit test is applicable for any raw materials, the retest
period shall be 1 year.

4.3 Note: If the retest date is exceed from the expiry date of the material then
expiry date to be considered as retest date.

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4.4 QC Officer/designee shall followed above retest period and mention the
retesting date on the “Approved” label.

4.5 Warehouse Head/designee shall prepare the list of raw materials for retesting
at starting of every month shall raise a "Test request form" and send it to QC
department.

4.6 QC Officer/designee shall enter details of test request form in Inward register
for retest of Raw material and allocate the A.R. No. as per the SOP.

4.7 QC Head/designee shall allocate the work to QC Officer/Executive/designee for

reanalysis as per the production priority.

4.8 The QC officer/designee shall sample the raw material as per the Raw material
sampling SOP.

4.9 QC Officer/designee shall test the Raw material as per SOP and perform only
those tests as mentioned in individual specification using respective standard test
procedure.

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SOP for retesting of raw material in pharmaceutical - PharmaSOPcorner https://www.pharmasopcorner.net/2018/03/sop-for-retesting-of-raw-materi...

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4.10 After completion of analysis, QC Officer/designee shall prepare the C OA as

per the SOP and attach with protocol. Officer will also attach all the raw data, C OA
of previous approved material, manufacturer C OA and copy of test request form
and hand over to QC Executive/designee for review.

4.11 QC Executive/designee shall check all the record thoroughly against the
individual specification and hand over to QC Head/designee for final approval.

4.12 QC Head/designee shall randomly check the data and approve the C OA.

4.13 After final approval, QC Executive /designee shall issue the

“APPROVED/REJEC TED” labels as per the number of packs in the consignment and
take in the entry in label issuance record.

4.14 QC Officer shall deface the previously approved label by cross(X) mark ,affix
duly filled and signed “APPROVED/REJEC TED” labels on below of previously
approved label of all packs/containers with revised retest period.

4.15 Enter the status of Raw material (release or reject) in Inward register for
retest of Raw material

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SOP for retesting of raw material in pharmaceutical - PharmaSOPcorner https://www.pharmasopcorner.net/2018/03/sop-for-retesting-of-raw-materi...

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4.16 QC Officer/designee shall dispose the left over sample as per the SOP.

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